Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; citric acid monohydrate; mannitol; hydrochloric acid; adipic acid; polysorbate 80; sodium hydroxide - rheumatoid arthritis hyrimoz? is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,hyrimoz? can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hyrimoz? in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). hyrimoz? can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hyrimoz? is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis hyrimoz? is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis hyrimoz? is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) hyrimoz? is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab.,ulcerative colitis hyrimoz? is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see section 5.1 clinical trials).,psoriasis in adults and children hyrimoz? is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. hyrimoz? is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) hyrimoz? is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis hyrimoz? is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; mannitol; sodium hydroxide; citric acid monohydrate; water for injections; hydrochloric acid; polysorbate 80; adipic acid - rheumatoid arthritis hyrimoz? is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,hyrimoz? can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hyrimoz? in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). hyrimoz? can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hyrimoz? is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis hyrimoz? is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis hyrimoz? is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) hyrimoz? is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab.,ulcerative colitis hyrimoz? is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see section 5.1 clinical trials).,psoriasis in adults and children hyrimoz? is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. hyrimoz? is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) hyrimoz? is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis hyrimoz? is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - abrilada is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. abrilada can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). abrilada is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. abrilada can be used alone or in combination with methotrexate. abrilada is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. abrilada can be used alone or in combination with non-biologic dmards. abrilada is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. abrilada is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. abrilada is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies (14.7)] . abrilada is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. abrilada should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions (5)] . abrilada is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. abrilada is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see data) . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16–19.7 mcg/ml in cord blood, 4.28–17.7 mcg/ml in infant serum, and 0–16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for abrilada and any potential adverse effects on the breastfed child from abrilada or from the underlying maternal condition. the safety and effectiveness of abrilada have been established for: pediatric assessments for abrilada demonstrate that abrilada is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, abrilada is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. postmarketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab-treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of abrilada in patients 65 years of age and older. in patients treated with abrilada, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . abrilada (ah brill-ah-dah) (adalimumab-afzb) 40 mg/0.8 ml single-dose prefilled pen injection, for subcutaneous (under the skin) use keep this leaflet. these instructions show step by step directions on how to prepare and give an injection. storage information: keep abrilada, injection supplies, and all other medicines out of the reach of children. abrilada for injection comes in a disposable (throw away) single-use pen that contains a single dose of medicine. abrilada for injection can be given by a patient, caregiver or healthcare provider. do not try to inject abrilada yourself until you are shown the right way to give the injections and read and understand the instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of abrilada at home, you should receive training on the right way to prepare and inject abrilada. it is important that you read, understand, and follow these instructions so that you inject abrilada the right way. it is important to talk to your healthcare provider to be sure you understand your abrilada dosing instructions. to help you remember when to inject abrilada, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject abrilada. step 1. supplies you need step 2. getting ready   questions and answers what should i do with my pen if it has been dropped? do not use it, even if it looks undamaged. dispose of your pen in the same way as a used pen. you will need to use a new pen to give your injection. can i use my pen straight from the refrigerator? yes, however you may find that using the pen at room temperature reduces stinging or discomfort. if you allow your pen to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine. what should i do if i need to travel? when you are traveling, you may store your pen in its carton at room temperature up to 86°f (30°c) for up to 30 days. is it okay to shake my pen before i use it? no, do not shake your pen. shaking can damage your medicine. when you check your medicine, gently tilt your pen back and forth while looking carefully into the window. it is normal to see one or more air bubbles. do i need to remove any air bubbles before using my pen? no, do not attempt to remove air bubbles. drops of medicine have appeared at the needle tip. is this okay? yes, it is normal to see a few drops of medicine at the needle tip when you remove the cap. can i re-insert the needle if i change my mind where i want to inject? no, you should not re-insert the needle into your skin. if you change your mind, you will need a replacement pen if the needle has already been inserted into the skin. after the injection button has been pressed, you must not lift your pen from the skin until the injection has finished. i pushed my pen against the skin but could not press the button down. what should i do? take your finger off the injection button and push your pen down more firmly against the skin. then try pushing the button again. if this does not work, stretching the skin may make the injection site firmer, making pressing the injection button easier. can i pinch or stretch the skin at the injection area? yes, pinching or stretching the skin before injection may make the injection site firmer, making it easier to press the injection button. do i need to keep my finger pressed on the injection button for the whole injection? no, you can stop pressing the button when the injection has started. however, make sure you keep holding the pen firmly against the skin. the pen will continue to deliver your medicine. how long will the injection take? from the time the dose begins until you hear the 2nd click, it usually takes 3 to 10 seconds. after the 2nd click, you should continue to hold your pen in place for at least 5 more seconds to make sure you give the full dose. what should i do if i see more than a small drop of medicine on the skin after giving my injection? nothing this time, but for your next injection wait a little longer before removing the pen from the skin to make sure all of the medicine went into your skin. what should i do if i have any questions about my abrilada pen or medicine? contact your healthcare provider or pharmacist. this instructions for use has been approved by the u.s. food and drug administration. manufactured by pfizer inc. new york, ny 10001 distributed by pfizer labs division of pfizer inc. new york, ny 10001 us license no. 2001 lab-1352-3.0 revised: 06/2023 abrilada (ah brill-ah-dah) (adalimumab-afzb) 10 mg/0.2 ml, 20 mg/0.4 ml, 40 mg/0.8 ml single-dose prefilled syringe injection, for subcutaneous (under the skin) use only keep this leaflet. these instructions show step by step directions on how to prepare and give an injection. storage information: keep abrilada, injection supplies, and all other medicines out of the reach of children. abrilada for injection comes in a disposable (throw away) single use prefilled syringe that contains a single dose of medicine. abrilada for injection can be given by a patient, caregiver or healthcare provider. do not try to inject abrilada yourself until you are shown the right way to give the injections and read and understand the instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of abrilada at home, you should receive training on the right way to prepare and inject abrilada. it is important that you read, understand, and follow these instructions so that you inject abrilada the right way. it is important to talk to your healthcare provider to be sure you understand your abrilada dosing instructions. to help you remember when to inject abrilada, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject abrilada. step 1. supplies you need step 2. getting ready wash your hands with soap and water, and dry completely. if you have any questions about your medicine, please contact your healthcare provider or pharmacist.   questions and answers what should i do with my prefilled syringe if it has been dropped? do not use it if it has been dropped or the carton containing your prefilled syringe has been dropped even if it looks undamaged. dispose of your prefilled syringe in the same way as a used prefilled syringe. you will need to use a new prefilled syringe to give your injection. can i use my prefilled syringe straight from the refrigerator? yes, however you may find that using the prefilled syringe at room temperature reduces stinging or discomfort. if you allow your prefilled syringe to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine. what should i do if i need to travel? when you are traveling, you may store your prefilled syringe in its carton at room temperature up to 86°f (30°c) for up to 30 days. is it okay to shake my prefilled syringe before i use it? no, do not shake your prefilled syringe. shaking can damage your medicine. when you check your medicine, gently tilt your syringe back and forth while looking carefully into the window. it is normal to see one or more bubbles. do i need to remove any air bubbles before using my prefilled syringe? no, do not attempt to remove air bubbles. drops of medicine have appeared at the needle tip. is this okay? yes, it is normal to see a few drops of medicine at the needle tip when you remove the needle cover. can i re-insert the needle into my skin? no, you should not re-insert the needle into the skin. you will need a replacement prefilled syringe if the needle has already been inserted into the skin. how long will the injection take? dose delivery will take approximately 2 to 5 seconds. remember to hold your prefilled syringe in place for at least 5 seconds after the plunger has been pushed down all the way. what should i do if i have any questions about my prefilled syringe or medicine? contact your healthcare provider or pharmacist. this instructions for use has been approved by the u.s. food and drug administration. manufactured by pfizer inc. new york, ny 10001 distributed by pfizer labs division of pfizer inc. new york, ny 10001 us license no. 2001 lab-1353-3.0 revised: 06/2023

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - abrilada is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. abrilada can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). abrilada is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. abrilada can be used alone or in combination with methotrexate. abrilada is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. abrilada can be used alone or in combination with non-biologic dmards. abrilada is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. abrilada is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. abrilada is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies (14.7)] . abrilada is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. abrilada should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions (5)] . abrilada is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. abrilada is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see data) . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16–19.7 mcg/ml in cord blood, 4.28–17.7 mcg/ml in infant serum, and 0–16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for abrilada and any potential adverse effects on the breastfed child from abrilada or from the underlying maternal condition. the safety and effectiveness of abrilada have been established for: pediatric assessments for abrilada demonstrate that abrilada is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, abrilada is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. postmarketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab-treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of abrilada in patients 65 years of age and older. in patients treated with abrilada, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . abrilada (ah brill-ah-dah) (adalimumab-afzb) 40 mg/0.8 ml single-dose prefilled pen injection, for subcutaneous (under the skin) use keep this leaflet. these instructions show step by step directions on how to prepare and give an injection. storage information: keep abrilada, injection supplies, and all other medicines out of the reach of children. abrilada for injection comes in a disposable (throw away) single-use pen that contains a single dose of medicine. abrilada for injection can be given by a patient, caregiver or healthcare provider. do not try to inject abrilada yourself until you are shown the right way to give the injections and read and understand the instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of abrilada at home, you should receive training on the right way to prepare and inject abrilada. it is important that you read, understand, and follow these instructions so that you inject abrilada the right way. it is important to talk to your healthcare provider to be sure you understand your abrilada dosing instructions. to help you remember when to inject abrilada, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject abrilada. step 1. supplies you need step 2. getting ready   questions and answers what should i do with my pen if it has been dropped? do not use it, even if it looks undamaged. dispose of your pen in the same way as a used pen. you will need to use a new pen to give your injection. can i use my pen straight from the refrigerator? yes, however you may find that using the pen at room temperature reduces stinging or discomfort. if you allow your pen to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine. what should i do if i need to travel? when you are traveling, you may store your pen in its carton at room temperature up to 86°f (30°c) for up to 30 days. is it okay to shake my pen before i use it? no, do not shake your pen. shaking can damage your medicine. when you check your medicine, gently tilt your pen back and forth while looking carefully into the window. it is normal to see one or more air bubbles. do i need to remove any air bubbles before using my pen? no, do not attempt to remove air bubbles. drops of medicine have appeared at the needle tip. is this okay? yes, it is normal to see a few drops of medicine at the needle tip when you remove the cap. can i re-insert the needle if i change my mind where i want to inject? no, you should not re-insert the needle into your skin. if you change your mind, you will need a replacement pen if the needle has already been inserted into the skin. after the injection button has been pressed, you must not lift your pen from the skin until the injection has finished. i pushed my pen against the skin but could not press the button down. what should i do? take your finger off the injection button and push your pen down more firmly against the skin. then try pushing the button again. if this does not work, stretching the skin may make the injection site firmer, making pressing the injection button easier. can i pinch or stretch the skin at the injection area? yes, pinching or stretching the skin before injection may make the injection site firmer, making it easier to press the injection button. do i need to keep my finger pressed on the injection button for the whole injection? no, you can stop pressing the button when the injection has started. however, make sure you keep holding the pen firmly against the skin. the pen will continue to deliver your medicine. how long will the injection take? from the time the dose begins until you hear the 2nd click, it usually takes 3 to 10 seconds. after the 2nd click, you should continue to hold your pen in place for at least 5 more seconds to make sure you give the full dose. what should i do if i see more than a small drop of medicine on the skin after giving my injection? nothing this time, but for your next injection wait a little longer before removing the pen from the skin to make sure all of the medicine went into your skin. what should i do if i have any questions about my abrilada pen or medicine? contact your healthcare provider or pharmacist. this instructions for use has been approved by the u.s. food and drug administration. manufactured by pfizer inc. new york, ny 10001 distributed by pfizer labs division of pfizer inc. new york, ny 10001 us license no. 2001 lab-1352-3.0 revised: 06/2023 abrilada (ah brill-ah-dah) (adalimumab-afzb) 10 mg/0.2 ml, 20 mg/0.4 ml, 40 mg/0.8 ml single-dose prefilled syringe injection, for subcutaneous (under the skin) use only keep this leaflet. these instructions show step by step directions on how to prepare and give an injection. storage information: keep abrilada, injection supplies, and all other medicines out of the reach of children. abrilada for injection comes in a disposable (throw away) single use prefilled syringe that contains a single dose of medicine. abrilada for injection can be given by a patient, caregiver or healthcare provider. do not try to inject abrilada yourself until you are shown the right way to give the injections and read and understand the instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of abrilada at home, you should receive training on the right way to prepare and inject abrilada. it is important that you read, understand, and follow these instructions so that you inject abrilada the right way. it is important to talk to your healthcare provider to be sure you understand your abrilada dosing instructions. to help you remember when to inject abrilada, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject abrilada. step 1. supplies you need step 2. getting ready wash your hands with soap and water, and dry completely. if you have any questions about your medicine, please contact your healthcare provider or pharmacist.   questions and answers what should i do with my prefilled syringe if it has been dropped? do not use it if it has been dropped or the carton containing your prefilled syringe has been dropped even if it looks undamaged. dispose of your prefilled syringe in the same way as a used prefilled syringe. you will need to use a new prefilled syringe to give your injection. can i use my prefilled syringe straight from the refrigerator? yes, however you may find that using the prefilled syringe at room temperature reduces stinging or discomfort. if you allow your prefilled syringe to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine. what should i do if i need to travel? when you are traveling, you may store your prefilled syringe in its carton at room temperature up to 86°f (30°c) for up to 30 days. is it okay to shake my prefilled syringe before i use it? no, do not shake your prefilled syringe. shaking can damage your medicine. when you check your medicine, gently tilt your syringe back and forth while looking carefully into the window. it is normal to see one or more bubbles. do i need to remove any air bubbles before using my prefilled syringe? no, do not attempt to remove air bubbles. drops of medicine have appeared at the needle tip. is this okay? yes, it is normal to see a few drops of medicine at the needle tip when you remove the needle cover. can i re-insert the needle into my skin? no, you should not re-insert the needle into the skin. you will need a replacement prefilled syringe if the needle has already been inserted into the skin. how long will the injection take? dose delivery will take approximately 2 to 5 seconds. remember to hold your prefilled syringe in place for at least 5 seconds after the plunger has been pushed down all the way. what should i do if i have any questions about my prefilled syringe or medicine? contact your healthcare provider or pharmacist. this instructions for use has been approved by the u.s. food and drug administration. manufactured by pfizer inc. new york, ny 10001 distributed by pfizer labs division of pfizer inc. new york, ny 10001 us license no. 2001 lab-1353-3.0 revised: 06/2023

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - belimumab, quantity: 200 mg/ml - injection, solution - excipient ingredients: sodium chloride; arginine hydrochloride; histidine hydrochloride monohydrate; histidine; polysorbate 80; water for injections - benlysta is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g. ana titre greater than or equal to 1:80 and/or anti-dsdna titre greater than or equal to 30 iu/ml) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,the safety and efficacy of benlysta have not been evaluated in patients with severe active central nervous system lupus.

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - belimumab, quantity: 200 mg/ml - injection, solution - excipient ingredients: sodium chloride; arginine hydrochloride; histidine hydrochloride monohydrate; histidine; polysorbate 80; water for injections - benlysta is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g. ana titre greater than or equal to 1:80 and/or anti-dsdna titre greater than or equal to 30 iu/ml) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,the safety and efficacy of benlysta have not been evaluated in patients with severe active central nervous system lupus.

United States - English - NLM (National Library of Medicine)

amgen inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - amjevita is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. amjevita can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). amjevita is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. amjevita can be used alone or in combination with methotrexate. amjevita is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. amjevita can be used alone or in combination with non-biologic dmards. amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. amjevita is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. amjevita is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf-blockers [see clinical studies (14.7)] . amjevita is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. amjevita should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see boxed warning and warnings and precautions (5)] . amjevita is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. amjevita is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see data ]. risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n = 10) and infant serum (n = 8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for amjevita and any potential adverse effects on the breastfed child from amjevita or from the underlying maternal condition. the safety and effectiveness of amjevita have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn's disease in pediatric patients 6 years of age and older. pediatric assessments for amjevita demonstrate that amjevita is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, amjevita is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to < 4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of amjevita in patients 65 years of age and older. in patients treated with amjevita, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . instructions for use welcome! the amjevita™ sureclick® autoinjector is a single-dose prefilled autoinjector. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita sureclick autoinjector for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using amjevita sureclick autoinjector. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™(am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled sureclick® autoinjector guide to parts important: needle is inside important before you use an amjevita sureclick autoinjector, read this important information: storing your amjevita sureclick autoinjectors - keep the amjevita sureclick autoinjector and all medicines out of the reach of children. - keep the amjevita sureclick autoinjector in the original carton to protect from light or physical damage. - the amjevita sureclick autoinjector should be kept in the refrigerator at 36°f to 46°f (2°c to 8°c). - if needed, you may store the amjevita sureclick autoinjector at room temperature up to 77°f (25°c) for up to 14 days. throw away amjevita if it has been kept at room temperature and not been used within 14 days. - do not store the amjevita sureclick autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita sureclick autoinjector - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita sureclick autoinjector after the expiration date on the label. - do not shake the amjevita sureclick autoinjector. - do not remove the yellow cap from the amjevita sureclick autoinjector until you are ready to inject. - do not use the amjevita sureclick autoinjector if it has been frozen. - do not use the amjevita sureclick autoinjector if it has been dropped on a hard surface. part of the amjevita sureclick autoinjector may be broken even if you cannot see the break. use a new amjevita sureclick autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the amjevita sureclick autoinjector is not made with natural rubber latex. for more information or help or call 1-800-77-amgen (1-800-772-6436). step 1: prepare a remove 1 amjevita sureclick autoinjector from the package. carefully lift the autoinjector straight up out of the box. put the original package with any unused autoinjectors back in the refrigerator. for a more comfortable injection, leave the autoinjector at room temperature for 15 to 30 minutes before injecting. - do not put the autoinjector back in the refrigerator once it has reached room temperature. - do not try to warm the autoinjector by using a heat source such as hot water or microwave. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector yet. b inspect the amjevita sureclick autoinjector. make sure the medicine in the window is clear and colorless to slightly yellow. - do not use the autoinjector if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the autoinjector has been dropped. the yellow cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the autoinjector has been dropped. - the yellow cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). c gather all materials needed for your injection. wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new autoinjector - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d prepare and clean your injection site. you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e pull yellow cap straight off, only when you are ready to inject. it is normal to see a drop of liquid at the end of the needle or yellow safety guard. - do not twist or bend the yellow cap. - do not put the yellow cap back onto the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. f stretch or pinch your injection site to create a firm surface. stretch method stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches wide. pinch method pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin stretched or pinched while injecting. step 3: inject g hold the stretch or pinch. with the yellow cap off, place the autoinjector on your skin at 90 degrees. h firmly push the autoinjector down onto skin until it stops moving. push down important: you must push all the way down but do not touch blue start button until you are ready to inject. i when you are ready to inject, press the blue start button. j keep pushing down on your skin. your injection could take about 10 seconds. window turns yellow when injection is done important: when you remove the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. call your doctor immediately. step 4: finish k discard (throw away) the used autoinjector and the yellow cap. - put the used sureclick autoinjector in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the sureclick autoinjector in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not reuse the autoinjector. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of the reach of children. l examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. commonly asked questions what will happen if i press the blue start button before i am ready to do the injection on my skin? can i move the autoinjector around on my skin while i am choosing an injection site? can i release the blue start button after i start my injection? will the blue start button pop up after i release my thumb? what do i do if i didn't hear a click after pushing the device down on my skin for 10 seconds? whom do i contact if i need help with the autoinjector or my injection? this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 07/2022 v2 turn over to continue……… welcome! amjevita™ is supplied as a single-dose prefilled syringe. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita prefilled syringe for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using the amjevita prefilled syringe. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled amjevita syringe guide to parts important: the needle is covered by the needle cap before use. important before you use an amjevita prefilled syringe, read this important information: storing your amjevita prefilled syringes - keep the amjevita prefilled syringe and all medicines out of the reach of children. - keep the amjevita prefilled syringe in the original carton to protect from light or physical damage. - the amjevita prefilled syringe should be kept in the refrigerator at 36° f to 46° f (2° c to 8° c). - if needed, you may store the amjevita prefilled syringe at room temperature up to 77° f (25° c) for up to 14 days. throw away amjevita if it has been kept at room temperature and has not been used within 14 days. - do not store the amjevita prefilled syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita prefilled syringe - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita prefilled syringe after the expiration date on the label. - do not shake the amjevita prefilled syringe. - do not remove the needle cap from the amjevita prefilled syringe until you are ready to inject. - do not use the amjevita prefilled syringe if it has been frozen. - do not use the amjevita prefilled syringe if it has been dropped on a hard surface. part of the amjevita prefilled syringe may be broken even if you cannot see the break. use a new amjevita prefilled syringe, and call 1-800-77-amgen (1-800-772-6436). - the amjevita prefilled syringe is not made with natural rubber latex. - for more information or help call 1-800-77-amgen (1-800-772-6436). step 1: prepare a   remove the prefilled syringe carton from the refrigerator. remove the number of amjevita prefilled syringes you need for your injection from the carton. grab the syringe barrel to remove the prefilled syringe from the tray as shown. put the original carton with any unused prefilled syringes back in the refrigerator. for safety reasons: - do not grab the plunger rod. - do not grab the needle cap. - do not remove the needle cap until you are ready to inject. - do not remove the finger flange. the finger flange is part of the syringe. for a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting. - do not put the syringe back in the refrigerator once it has reached room temperature. - do not try to warm the syringe by using a heat source such as hot water or microwave. - do not leave the syringe in direct sunlight. - do not shake the syringe. important: always hold the prefilled syringe by the syringe barrel. b   inspect the amjevita prefilled syringe. always hold the syringe by the syringe barrel. make sure the medicine in the syringe is clear and colorless to slightly yellow. - do not use the syringe if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the needle cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the needle cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new syringe, and call 1-800-77-amgen (1-800-772-6436). c   gather all materials needed for your injection(s). wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new syringe(s) - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d   prepare and clean your injection site(s).          you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e   hold the prefilled syringe by the syringe barrel with the needle cap pointing up. carefully pull the needle cap straight off and away from your body when you are ready to inject. it is normal to see a drop of liquid at the end of the needle. - do not twist or bend the needle cap. - do not put the needle cap back onto the syringe. - do not remove the needle cap from the syringe until you are ready to inject. important: throw the needle cap into the sharps disposal container provided. f   pinch your injection site to create a firm surface. pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin pinched while injecting. step 3: inject g   hold the pinch. with the needle cap off, insert the syringe into your skin at 45 to 90 degrees. do not place your finger on the plunger rod while inserting the needle. h   using slow and constant pressure, push the plunger rod all the way down until it reaches the bottom. do not pull back the plunger rod while the needle is inserted. i   when done, release your thumb, and gently pull the syringe off of your skin. step 4: finish j   discard (throw away) the used prefilled syringe and the needle cap. do not use any medicine that is left in the used syringe. - put the used amjevita prefilled syringe in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not reuse the syringe. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of the reach of children. k   examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. this instructions for use has been approved by the u.s. food and drug administration. manufactured by : amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 7/2022 v2 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) 10 mg/0.2 ml injection, for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that a caregiver may be able to give your injections of amjevita at home, they should receive training on the right way to prepare and inject amjevita. do not try to inject until they have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex.   important: keep the syringe and sharps disposal container out of the sight and reach of children. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com, or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. important: keep the syringe out of the sight and reach of children. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68° f to 77° f (20° c to 25° c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68° f to 77° f (20° c to 25° c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored or has flakes. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at about a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on the injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the us food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 04/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 40 mg/0.4 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 10 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 80 mg/0.8 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 15 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita dosing: - amjevita comes in 3 different doses: 20 mg/0.2 ml, 40 mg/0.4 ml, and 80 mg/0.8 ml. check your prescription to make sure you have the correct dose. - the color and look of the prefilled syringe will be different for each dose. the amount of medicine in the syringe will also be different for each dose. - for example, it is okay for the 20 mg/0.2 ml dose to have a small amount of medicine and the 80 mg/0.8 ml to have a large amount of medicine. check the illustrations below to see what your dose looks like in the syringe. 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave, or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for the injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom of the syringe to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023

United States - English - NLM (National Library of Medicine)

celltrion usa, inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - yuflyma is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. yuflyma can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). yuflyma is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. yuflyma can be used alone or in combination with methotrexate. yuflyma is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. yuflyma can be used alone or in combination with non-biologic dmards. yuflyma is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. yuflyma is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. yuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies (14.7)] . yuflyma is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. yuflyma should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions (5)] . yuflyma is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. yuflyma is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease- matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data) . adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see clinical considerations) . in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see data] . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for yuflyma and any potential adverse effects on the breastfed child from yuflyma or from the underlying maternal condition. the safety and effectiveness of yuflyma have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn's disease in pediatric patients 6 years of age and older. pediatric assessments for yuflyma demonstrate that yuflyma is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, yuflyma is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, yuflyma was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to < 4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of yuflyma in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of yuflyma have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of yuflyma for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of yuflyma for this indication is supported by yuflyma's approval as a biosimilar to adalimumab and evidence from adequate and well-controlled studies in adults with additional data of adalimumab from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of yuflyma have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of yuflyma in patients 65 years of age and older. in patients treated with yuflyma, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2) ]. for subcutaneous use only read and follow the instructions for use that come with your yuflyma auto-injector before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or treatment. important information - use the auto-injector only if your doctor has trained you on the right way to prepare for and to give an injection. - ask your doctor how often you will need to give an injection. - do not shake the auto-injector at any time. - do not remove the cap until you are ready to inject. - do not share the auto-injector with anyone. how to store the auto-injector - store the auto-injector in a refrigerator between 36°f to 46°f (2°c to 8°c). - keep the auto-injector in the original carton until use to protect it from light. - do not use an auto-injector that has been left in direct sunlight. - do not freeze the auto-injector. if the auto-injector has been frozen, do not use the auto-injector even if it is thawed. - if needed, you may store the auto-injector at room temperature up to 77°f (25°c) for up to 31 days. - after the auto-injector has reached room temperature, do not put it back in the refrigerator. - keep the auto-injector and all medicines out of the reach of children. read instructions on all pages before using the yuflyma auto-injector prepare for injection - do not  use the auto-injector if;-it is cracked or damaged.-the expiration date has passed. figure b - do not use the auto-injector if the liquid is the discolored (yellow or dark brown), cloudy, or contains particles in it. - you may see air bubbles in the liquid. this is normal. figure c - do not warm the auto-injector using heat sources such as hot water or a microwave. figure d - do not inject into skin that is within 2 in (5 cm) of your belly button (navel), or is red, hard, tender, damaged, bruised, or scarred. - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. - do not inject the same injection site each time you give an injection. - each new injection site should be at least 1.2 in (3 cm) away from the injection site you used before. figure e figure f - do not blow on or touch the injection site again before giving the injection. figure g - do not recap the auto-injector. - do not remove the cap until you are ready to inject. - do not touch the needle or needle cover. doing so may result in a needle stick injury because the needle is inside the needle cover. figure h figure i - when the injection starts you will hear the 1st loud "click" and the blue plunger rod will begin to fill the window. - do not change the position of the auto-injector after the injection has started. figure j - after you remove the auto-injector from the injection site, the needle will be automatically covered (see figure l ). - if the window has not turned completely blue or if the medicine is still injecting, this means you have not received a full dose. call your doctor immediately. - you may see grey stopper in the window. this is normal. - some bleeding may occur. - do not reuse the auto-injector. - do not rub the injection site. figure k figure l - do not throw away (dispose of) the auto-injector in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is:-made of a heavy-duty plastic,-can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,-upright and stable during use,-leak-resistant, and-properly labeled to warn of hazardous waste inside the container. figure m - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for subcutaneous use only read and follow the instructions for use that come with your yuflyma prefilled syringe before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or treatment. important information - use the prefilled syringe with needle guard only if your doctor has trained you on the right way to prepare for and to give an injection. - ask your doctor how often you will need to give an injection. - do not shake the prefilled syringe at any time. - do not remove the cap until you are ready to inject. - do not share the prefilled syringe with anyone. - only use each prefilled syringe for one injection. - do not pull back on the plunger rod at any time. how to store the prefilled syringe - store the prefilled syringe in a refrigerator between 36°f to 46°f (2°c to 8°c). - keep the prefilled syringe in the original carton to protect it from light. - do not use a prefilled syringe that has been left in direct sunlight. - do not freeze the prefilled syringe. if the prefilled syringe has been frozen, do not use the prefilled syringe even if it is thawed. - if needed, you may store the prefilled syringe at room temperature up to 77°f (25°c) for up to 31 days. - after the prefilled syringe has reached room temperature, do not put it back in the refrigerator. - keep the prefilled syringe and all medicines out of the reach of children. read instructions on all pages before using the yuflyma prefilled syringe prepare for injection - hold the prefilled syringe body when removing it from the carton. do not touch the plunger rod. - do not  use the prefilled syringe if;-it is cracked or damaged.-the expiration date has passed. figure b - do not use the prefilled syringe if the liquid is the discolored (yellow or dark brown), cloudy, or contains particles in it. - you may see air bubbles in the liquid. this is normal. figure c - do not warm the prefilled syringe using heat sources such as hot water or a microwave. figure d - do not inject into skin that is within 2 in (5 cm) of your belly button (navel), or is red, hard, tender, damaged, bruised, or scarred. - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. figure e figure f - do not blow on or touch the injection site again before giving the injection. figure g - do not pull back on the plunger rod at any time. - do not recap the prefilled syringe. - do not remove the cap until you are ready to inject. - do not touch the needle. doing so may result in a needle stick injury. figure h - do not change the position of the prefilled syringe after the injection has started. figure i figure j - some bleeding may occur. - do not reuse the prefilled syringe. - do not touch or recap the needle. - do not rub the injection site. figure k - do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is:-made of a heavy-duty plastic,-can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,-upright and stable during use,-leak-resistant, and-properly labeled to warn of hazardous waste inside the container. figure l - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for subcutaneous use only read and follow the instructions for use that come with your yuflyma prefilled syringe before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or treatment. important information - use the prefilled syringe only if your doctor has trained you on the right way to prepare for and to give an injection. - ask your doctor how often you will need to give an injection. - do not shake the prefilled syringe at any time. - do not remove the cap until you are ready to inject. - do not share the prefilled syringe with anyone. - do not pull back on the plunger rod at any time. how to store the prefilled syringe - store the prefilled syringe in a refrigerator between 36°f to 46°f (2°c to 8°c). - keep the prefilled syringe in the original carton to protect it from light. - do not use a prefilled syringe that has been left in direct sunlight. - do not freeze the prefilled syringe. if the prefilled syringe has been frozen, do not use the prefilled syringe even if it is thawed. - if needed, you may store the prefilled syringe at room temperature up to 77°f (25°c) for up to 31 days. - after the prefilled syringe has reached room temperature, do not put it back in the refrigerator. - keep the prefilled syringe and all medicines out of the reach of children. read instructions on all pages before using the yuflyma prefilled syringe prepare for injection - hold the prefilled syringe body when removing it from the carton. do not touch the plunger rod. - do not  use the prefilled syringe if;-it is cracked or damaged.-the expiration date has passed. figure b - do not use the prefilled syringe if the liquid is the discolored (yellow or dark brown), cloudy, or contains particles in it. - you may see air bubbles in the liquid. this is normal. figure c - do not warm the prefilled syringe using heat sources such as hot water or a microwave. figure d - do not inject into skin that is within 2 in (5 cm) of your belly button (navel), or is red, hard, tender, damaged, bruised, or scarred. - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. figure e figure f - do not blow on or touch the injection site again before giving the injection. figure g - do not pull back on the plunger rod at any time. - do not recap the prefilled syringe. - do not remove the cap until you are ready to inject. - do not touch the needle. doing so may result in a needle stick injury. figure h - do not change the position of the prefilled syringe after the injection has started. figure i figure j - some bleeding may occur. - do not reuse the prefilled syringe. - do not touch the needle. - do not rub the injection site. figure k - do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is:-made of a heavy-duty plastic,-can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,-upright and stable during use,-leak-resistant, and-properly labeled to warn of hazardous waste inside the container. figure l - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container.

United States - English - NLM (National Library of Medicine)

mylan specialty l.p. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - hulio is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. hulio can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). hulio is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. hulio can be used alone or in combination with methotrexate. hulio is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. hulio can be used alone or in combination with non-biologic dmards. hulio is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. hulio is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older . hulio is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies (14.7, 14.8)] . hulio is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. hulio should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions (5)] . hulio is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients . hulio is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients . none. available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn’s disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see data) . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for hulio and any potential adverse effects on the breastfed child from hulio or from the underlying maternal condition. the safety and effectiveness of hulio have been established for: pediatric assessments for hulio demonstrate that hulio is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, hulio is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero-exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn’s disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn’s disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of hulio in patients 65 years of age and older. in patients treated with hulio, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . for subcutaneous (under the skin) use only read these instructions carefully before using your pen. this information does not replace talking to your healthcare provider about your medical condition and your treatment. do not try to inject hulio yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of hulio at home, you should receive training on the right way to prepare and inject hulio. it is important that you read, understand, and follow these instructions so that you inject hulio the right way. it is also important to talk to your healthcare provider to be sure you understand your hulio dosing instructions. to help you remember when to inject hulio, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver has any questions about the right way to inject hulio. for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) caution: never put your thumb, fingers, or hand over the orange activator after cap is removed. never press or push the orange activator with your thumb, fingers, or hand. the orange activator is where the needle comes out. if accidental injection to your fingers or hands occurs, apply first-aid and either call your healthcare provider or go to the nearest hospital emergency room if needed.   dosage: hulio pen is for single dose (1-time) use only. important: do not use hulio if frozen, even if it has been thawed. do not uncap your hulio pen until you are ready to inject and will not be interrupted. do not recap. recapping your hulio pen can damage the needle. a loud “click” will occur when the orange activator is pressed down to deliver your dose of hulio. parts of the hulio pen storing and handling the hulio pen if needed, for example when traveling, hulio may be stored at room temperature up to 77°f (25°c) for a period of up to 14 days, with protection from light. discard (throw away) hulio if not used within the 14-day period. record the date on the carton and dose tray when hulio is first removed from the refrigerator. gather supplies for injection find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive an injection. supplies you will need: included in hulio carton not included in hulio carton if you do not have all the supplies you need to give yourself an injection, visit or call your local pharmacist. preparing the pen remove the pen from the refrigerator 30 minutes before using. check the viewing window to make sure: do not use the pen if medicine is not near the fill marker. use another pen or contact your healthcare provider. do not use the pen if it is cloudy, discolored, or has particles in it. choosing and preparing injection site your healthcare provider should show you proper injection site techniques. giving the injection caution:  injection process must be completed without interruption. read all steps first before beginning injection. step 1 uncap important: step 2 squeeze and hold injection site the thigh injection site is shown here (see figure f). perform these steps the same way for abdomen (belly) injection sites.   step 3 place pen step 4 begin injection step 5 hold down for 2nd “click”, orange indicator and 10 seconds continue pushing the body of the pen down against the injection site until: caution: make sure all three of these have occurred to ensure all medicine was delivered. if the needle did not retract or you do not think you received the full dose, contact your healthcare provider for assistance. step 6 end of injection, remove hulio pen dispose of the hulio pen and cap put the used pen and cap in an fda-cleared sharps disposal container or puncture resistant container right away to avoid injury (see “how should i throw away (dispose of) the used hulio pen and cap?” in step 7). pen is for single-dose only. do not reuse the pen if all of the medicine was not injected. do not try to recap the pen as it could lead to a needle stick injury. step 7 how should i throw away (dispose of) the used hulio pen and cap? if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and pens. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. step 8 write down the date you received your injection and the injection site used in the injection diary. injection diary date injection site used           customer service for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) the brands listed are trademarks of their respective owners. hulio is a registered trademark of fujifilm kyowa kirin biologics co., ltd., licensed to the viatris companies. the hulio logo is a trademark of bgp products operations gmbh, a viatris company. © 2022 viatris inc. manufactured by: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured for: mylan specialty l.p. morgantown, wv 26505 u.s.a. u.s. license no. 2210 product of japan this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2022 pci:adal:ifup:rx6 697892 for subcutaneous (under the skin) use only read these instructions carefully before using your syringe. this information does not replace talking to your healthcare provider about your medical condition and your treatment. do not try to inject hulio yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of hulio at home, you should receive training on the right way to prepare and inject hulio. it is important that you read, understand, and follow these instructions so that you inject hulio the right way. it is also important to talk to your healthcare provider to be sure you understand your hulio dosing instructions. to help you remember when to inject hulio, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver has any questions about the right way to inject hulio. for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) dosage: hulio prefilled syringe is for single dose (1-time) use only.   important: parts of the hulio prefilled syringe (syringe) see figure a storing and handling the syringe if needed, for example when traveling, hulio may be stored at room temperature up to 77°f (25°c) for a period of up to 14 days, with protection from light. discard (throw away) hulio if not used within the 14-day period. record the date on the carton and dose tray when hulio is first removed from the refrigerator. gather supplies for injection find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive an injection. supplies you will need: included in the hulio carton not included in hulio carton if you do not have all the supplies you need to give yourself an injection, visit or call your local pharmacist. preparing the syringe remove the syringe from the refrigerator 30 minutes before using. check the viewing window to make sure: do not use the syringe if medicine is not near the fill marker. use another syringe or contact your healthcare provider. do not use the syringe if it is cloudy, discolored, or has particles in it. choosing and preparing injection site your healthcare provider should show you proper injection site techniques. giving the injection caution:    injection process must be completed without interruption. read all steps first before beginning injection. step 1 uncap caution: step 2 squeeze and hold injection site the thigh injection site is shown here (see figure f). perform these steps the same way for abdomen (belly) injection sites. step 3 insert needle into site at a 45° angle to the injection site, with your other hand use a quick dart-like motion to insert the needle into the site (see figure g). be careful to insert the needle so that it will not inject into your fingers holding the injection site. step 4 inject medicine after the needle is in, let go of squeezing the injection site. slowly push the plunger all the way down with your thumb until all the medicine is injected and the syringe is empty (see figure h). if the plunger is not pressed all the way down the needle safety feature will not activate afterwards to cover the needle. do not move, twist, or rotate syringe during injection. step 5 end of injection, remove syringe pull the syringe away from the injection site, then release your thumb from the plunger. the needle will retract and the needle safety feature will cover the needle (see figure i). caution: if the needle did not retract or you do not think you received the full dose, contact your healthcare provider for assistance. if the needle does not retract, carefully place the syringe into a sharps or puncture resistant container to avoid injury. dispose of the hulio syringe and needle cap put the used syringe and needle cap in an fda-cleared sharps disposal container or puncture resistant container right away to avoid injury (see “how should i throw away (dispose of) the used hulio prefilled syringe and needle cap?” in step 6). syringe is for single-dose only. do not reuse the syringe even if all of the medicine was not injected. do not try to recap the needle as it could lead to a needle stick injury. step 6 how should i throw away (dispose of) the used hulio prefilled syringe and needle cap? if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. step 7 write down the date you received your injection and the injection site used in the injection diary. injection diary date injection site used             customer service for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) the brands listed are trademarks of their respective owners. hulio is a registered trademark of fujifilm kyowa kirin biologics co., ltd., licensed to the viatris companies. the hulio logo is a trademark of bgp products operations gmbh, a viatris company. © 2022 viatris inc. manufactured by: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured for: mylan specialty l.p. morgantown, wv 26505 u.s.a. u.s. license no. 2210 product of japan this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2022 pci:adal:ifus:rx5 697925

Israel - English - Ministry of Health

amgen europe b.v. - adalimumab - solution for injection - adalimumab 50 mg / 1 ml - adalimumab - rheumatoid arthritisamgevita in combination with methotrexate is indicated for:• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.axial spondyloarthritisankylosing spondylitis (as):amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.axial spondyloarthritis without radiographic evidence of as:amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as, but with objective signs of inflammation by radiological and/or laboratory tests including mri and serum crp levels, who have had an inadequate response to, or are intolerant to, non - steroidal anti-inflammatory drugs.psoriatic arthritisamgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease to improve physical function.psoriasisamgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.hidradenitis suppurativa (hs)amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hs therapy.crohn’s diseaseamgevita is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn’s disease who have had an inadequate response to conventional therapy. amgevita is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.ulcerative colitisamgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.uveitisamgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.intestinal behcet's diseaseamgevita is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.