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

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

pfizer laboratories div pfizer inc - dofetilide (unii: r4z9x1n2nd) (dofetilide - unii:r4z9x1n2nd) - dofetilide 0.125 mg - tikosyn is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [af/afl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. because tikosyn can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. in general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). tikosyn is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. tikosyn has not been shown to be effective in patients with paroxysmal atrial fibrillation. tikosyn is contraindicated in patients with congenital or acquired long qt syndromes. tikosyn should not be used in patients with a baseline qt interval or qtc >440 msec (500 msec in patients wi

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - varenicline tartrate 0.85mg equivalent to 0.5 mg varenicline;  ;   - film coated tablet - 0.5 mg - active: varenicline tartrate 0.85mg equivalent to 0.5 mg varenicline     excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry clear ys-2-19114-a opadry white ys-1-18202 - an aid to smoking cessation

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - varenicline tartrate 1.71mg equivalent to 1 mg varenicline;  ;   - film coated tablet - 1 mg - active: varenicline tartrate 1.71mg equivalent to 1 mg varenicline     excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry blue 03b90547 opadry clear ys-2-19114-a - an aid to smoking cessation

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - varenicline tartrate 0.85mg equivalent to 0.5 mg varenicline;  ;  ; varenicline tartrate 1.71mg equivalent to 1 mg varenicline - combination - 0.5 mg and 1 mg - active: varenicline tartrate 0.85mg equivalent to 0.5 mg varenicline     excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry clear ys-2-19114-a opadry white ys-1-18202 active: varenicline tartrate 1.71mg equivalent to 1 mg varenicline excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry blue 03b90547 opadry clear ys-2-19114-a - an aid to smoking cessation

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

pfizer laboratories div pfizer inc - sunitinib malate (unii: lvx8n1ut73) (sunitinib - unii:v99t50803m) - sunitinib 12.5 mg - sutent is indicated for the treatment of adult patients with gastrointestinal stromal tumor (gist) after disease progression on or intolerance to imatinib mesylate. sutent is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc). sutent is indicated for the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy. sutent is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pnet) in adult patients with unresectable locally advanced or metastatic disease. none. risk summary based on animal reproduction studies and its mechanism of action, sutent can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform a drug-associated risk. in animal developmental and reproductive toxicology studies, oral administration of sunitinib to pregnant rats and rabbits throughout organogenesis resulted in teratogenicity (embryolet

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

pfizer laboratories div pfizer inc - ritlecitinib tosylate (unii: eag4t1459k) (ritlecitinib - unii:2oye00pc25) - litfulo is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. limitations of use : not recommended for use in combination with other jak inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. litfulo is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see warnings and precautions (5.6)] .       if a patient becomes pregnant while receiving litfulo, healthcare providers should report litfulo exposure by calling 1-877-390-2940. risk summary available data from clinical trials with litfulo use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparison, respectively (see animal data) . the background risks of major birth defects and miscarriage for the indicated population are unknown. all pregnancies carry some risk of birth defects, loss, or other adverse outcomes. the estimated background risks in the u.s. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively. data animal data in an embryo-fetal development study in pregnant rats, oral administration of ritlecitinib from gestation days 6 to 17 decreased fetal body weights and caused fetal skeletal malformations (malformed vertebrae and ribs) and variations (delayed ossification) at doses ≥175 mg/kg/day (49 times the mrhd based on auc comparison). maternal toxicity (lower body weights) was noted at 325 mg/kg/day (102 times the mrhd based on auc comparison). there was no developmental toxicity at 75 mg/kg/day (16 times the mrhd based on auc comparison). in an embryo-fetal development study in pregnant rabbits, oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased visceral malformations (malpositioned kidneys), skeletal malformations (supernumerary sternebrae, absent thoracic arch, and/or fused thoracic centra), and skeletal variations (delayed ossification) at 75 mg/kg/day (55 times the mrhd based on auc comparison). there was no developmental toxicity at doses up to 25 mg/kg/day (12 times the mrhd based on auc comparison). in a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through lactation day 20 had no effects on pre- and postnatal development at doses up to 75 mg/kg/day (14 times the mrhd based on auc comparison). at 175 mg/kg/day (41 times the mrhd based on auc comparison), ritlecitinib caused adverse lower postnatal survival and lower offspring body weights, which correlated with delayed sexual maturation in both sexes. bred females in the f1 generation also exhibited lower mean numbers of corpora lutea at 175 mg/kg/day. risk summary there are no data on the presence of ritlecitinib in human milk, the effects on the breastfed infant, or the effects on milk production. ritlecitinib is present in the milk of lactating rats (see data) . when a drug is present in animal milk, it is likely that it will be present in human milk. because of the serious adverse effects in adults, including risks of serious infection and malignancy, advise women not to breastfeed during treatment with litfulo and for approximately 14 hours after the last dose (approximately 6 elimination half-lives). data after a single oral 30 mg/kg dose of ritlecitinib to lactating rats, ritlecitinib concentrations in milk over time were higher than those in plasma. the mean milk to plasma auc ratio was 2.2. the safety and effectiveness of litfulo for the treatment of alopecia areata have been established in pediatric patients ages 12 years and older. a total of 181 pediatric patients ages 12 to <18 years were enrolled in alopecia areata clinical trials, with 105 pediatric patients ages 12 to <18 years with alopecia areata randomized in a pivotal, double-blind, placebo-controlled trial (trial aa-i). efficacy was consistent between the pediatric patients and adults [see clinical studies (14)] . the adverse reaction profile in the pediatric patients was similar to adults. the safety and efficacy of litfulo have not been established in pediatric patients under 12 years of age. no dose adjustment is required for patients ≥65 years of age. a total of 28 patients enrolled in alopecia areata trials were 65 years of age and older, and none were 75 years of age and older. clinical trials of litfulo did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. as there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly. no dose adjustment is required in patients with mild (child pugh a) or moderate (child pugh b) hepatic impairment. litfulo is not recommended in patients with severe (child pugh c) hepatic impairment [see dosage and administration (2.3) and clinical pharmacology (12.3)] .

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

pfizer australia pty ltd - mitozantrone hydrochloride -

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

pfizer australia pty ltd - mitozantrone hydrochloride -