ארצות הברית - אנגלית - 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.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sandoz inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - hyrimoz 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. hyrimoz can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). hyrimoz is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. hyrimoz can be used alone or in combination with methotrexate. hyrimoz is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. hyrimoz can be used alone or in combination with non-biologic dmards. hyrimoz is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. hyrimoz is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older. hyrimoz 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)] . hyrimoz 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. hyrimoz 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)] . hyrimoz is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. hyrimoz 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 to 19.7 mcg/ml in cord blood, 4.28 to 17.7 mcg/ml in infant serum, and 0 to 16.1 mcg/ml in maternal serum. in all but 1 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 hyrimoz and any potential adverse effects on the breastfed child from hyrimoz or from the underlying maternal condition. the safety and effectiveness of hyrimoz have been established for: pediatric assessments for hyrimoz demonstrate that hyrimoz is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, hyrimoz 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 hyrimoz have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of hyrimoz 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 hyrimoz 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 hyrimoz 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 hyrimoz in patients 65 years of age and older. in patients treated with hyrimoz, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)]. hyrimoz® (hye-ri-moze) (adalimumab-adaz) 40 mg/0.8 ml 20 mg/0.4 ml single-dose prefilled syringe with bd ultrasafe passive™ needle guard and finger flange injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe with bd ultrasafe passive™ needle guard and finger flange it is important that you: how should you store hyrimoz single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are: figure b : items not included in the carton before your injection figure c : needle guard is not activated – the single-dose prefilled syringe is ready for use figure d : needle guard is activated – do not use preparing the prefilled syringe contact your pharmacist if: figure e : choose your injection site figure f : clean your injection site figure g : pull the needle cap off figure h : insert the needle figure i : hold the syringe figure j : lift the needle straight out figure k : slowly release the plunger figure l: dispose of your used prefilled syringe manufactured by : sandoz inc. princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 80 mg/0.8 ml, 40 mg/0.4 ml single-dose prefilled syringe with bd ultrasafe passive™ needle guard and finger flange injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe with bd ultrasafe passive™ needle guard and finger flange it is important that you: how should you store hyrimoz single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are: figure b : items not included in the carton before your injection figure c : needle guard is not activated – the single-dose prefilled syringe is ready for use figure d : needle guard is activated – do not use preparing the prefilled syringe contact your pharmacist if: figure e : choose your injection site figure f : clean your injection site figure g : pull the needle cap off figure h : insert the needle figure i : hold the syringe figure j : lift the needle straight out figure k : slowly release the plunger figure l: dispose of your used prefilled syringe manufactured by : sandoz inc. princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 40 mg/0.8 ml single-dose prefilled sensoready® pen injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled sensoready pen before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz sensoready pen parts in figure a, the sensoready pen is shown with the cap removed. do not remove the cap until you are ready to inject. it is important that you: note: hyrimoz prefilled syringe and injection device are not made with natural rubber latex. how should you store your sensoready pen? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your sensoready pen carton are: not included in your sensoready pen carton are: figure b : items not included in the carton before your injection preparing the sensoready pen figure c : safety checks before injection contact your pharmacist if: figure d : choose your injection site figure e : clean your injection site figure f : remove the cap figure g : hold your pen your injection you must keep holding your sensoready pen firmly against your skin until you see a green indicator fill the window and stop moving. figure h : start your injection figure i : complete your injection after your injection figure j : check the green indicator figure k : dispose of your used pen manufactured by : sandoz inc. princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 80 mg/0.8 ml, 40 mg/0.4 ml single-dose prefilled sensoready® pen injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled sensoready pen before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz sensoready pen parts in figure a, the sensoready pen is shown with the cap removed. do not remove the cap until you are ready to inject. it is important that you: note: hyrimoz prefilled syringe and injection device are not made with natural rubber latex. how should you store your sensoready pen? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your sensoready pen carton are: not included in your sensoready pen carton are: figure b : items not included in the carton before your injection preparing the sensoready pen figure c : safety checks before injection contact your pharmacist if: figure d : choose your injection site figure e : clean your injection site figure f : remove the cap figure g : hold your pen your injection you must keep holding your sensoready pen firmly against your skin until you see a green indicator fill the window and stop moving. figure h : start your injection figure i : complete your injection after your injection figure j : check the green indicator figure k : dispose of your used pen manufactured by : sandoz inc. princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 10 mg/0.2 ml single-dose prefilled syringe injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe. it is important that you:    note: hyrimoz prefilled syringe is not made with natural rubber latex.   how should you store hyrimoz  single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children.   what do you need for your injection?    included in your prefilled syringe carton is: not included in your hyrimoz prefilled syringe carton are (see figure b ): figure b : items not included in the carton preparing the prefilled syringe    contact your pharmacist if:    figure c : choose your injection site.      figure d : choose your injection site.      figure e : pull the needle cap off.         figure f : pinch the skin and insert the needle.     figure g : press down the plunger.        figure h : dispose of the used prefilled syringe. manufactured by: sandoz inc. princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 10 mg/0.1 ml, 20 mg/0.2 ml single-dose prefilled syringe injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe. it is important that you:    note: hyrimoz prefilled syringe is not made with natural rubber latex.   how should you store hyrimoz  single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children.   what do you need for your injection?    included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are (see figure b ): figure b : items not included in the carton preparing the prefilled syringe    contact your pharmacist if:    figure c : choose your injection site.      figure d : clean your injection site.        figure e : pull the needle cap off.         figure f : pinch the skin and insert the needle.     figure g : press down the plunger.        figure h : dispose of the used prefilled syringe. manufactured by: sandoz inc. princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

cordavis limited - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - hyrimoz 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. hyrimoz can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). hyrimoz is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. hyrimoz can be used alone or in combination with methotrexate. hyrimoz is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. hyrimoz can be used alone or in combination with non-biologic dmards. hyrimoz is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. hyrimoz is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older. hyrimoz 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)] . hyrimoz 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. hyrimoz 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)] . hyrimoz is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients . hyrimoz 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 to 19.7 mcg/ml in cord blood, 4.28 to 17.7 mcg/ml in infant serum, and 0 to 16.1 mcg/ml in maternal serum. in all but 1 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 hyrimoz and any potential adverse effects on the breastfed child from hyrimoz or from the underlying maternal condition. the safety and effectiveness of hyrimoz have been established for: pediatric assessments for hyrimoz demonstrate that hyrimoz is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, hyrimoz 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 hyrimoz have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of hyrimoz 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 hyrimoz 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 hyrimoz 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 hyrimoz in patients 65 years of age and older. in patients treated with hyrimoz, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)]. hyrimoz® (hye-ri-moze) (adalimumab-adaz) 40 mg/0.8 ml 20 mg/0.4 ml single-dose prefilled syringe with bd ultrasafe passive™ needle guard and finger flange injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe with bd ultrasafe passive™ needle guard and finger flange it is important that you: how should you store hyrimoz single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are: figure b : items not included in the carton before your injection figure c : needle guard is not activated – the single-dose prefilled syringe is ready for use figure d : needle guard is activated – do not use preparing the prefilled syringe contact your pharmacist if: figure e : choose your injection site figure f : clean your injection site figure g : pull the needle cap off figure h : insert the needle figure i : hold the syringe figure j : lift the needle straight out figure k : slowly release the plunger figure l: dispose of your used prefilled syringe manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 80 mg/0.8 ml, 40 mg/0.4 ml single-dose prefilled syringe with bd ultrasafe passive™ needle guard and finger flange injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe with bd ultrasafe passive™ needle guard and finger flange it is important that you: how should you store hyrimoz single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are: figure b : items not included in the carton before your injection figure c : needle guard is not activated – the single-dose prefilled syringe is ready for use figure d : needle guard is activated – do not use preparing the prefilled syringe contact your pharmacist if: figure e : choose your injection site figure f : clean your injection site figure g : pull the needle cap off figure h : insert the needle figure i : hold the syringe figure j : lift the needle straight out figure k : slowly release the plunger figure l: dispose of your used prefilled syringe manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 40 mg/0.8 ml single-dose prefilled sensoready® pen injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled sensoready pen before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz sensoready pen parts in figure a, the sensoready pen is shown with the cap removed. do not remove the cap until you are ready to inject. it is important that you: note: hyrimoz prefilled syringe and injection device are not made with natural rubber latex. how should you store your sensoready pen? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your sensoready pen carton are: not included in your sensoready pen carton are: figure b : items not included in the carton before your injection preparing the sensoready pen figure c : safety checks before injection contact your pharmacist if: figure d : choose your injection site figure e : clean your injection site figure f : remove the cap figure g : hold your pen your injection you must keep holding your sensoready pen firmly against your skin until you see a green indicator fill the window and stop moving. figure h : start your injection figure i : complete your injection after your injection figure j : check the green indicator figure k : dispose of your used pen manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 80 mg/0.8 ml, 40 mg/0.4 ml single-dose prefilled sensoready® pen injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled sensoready pen before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz sensoready pen parts in figure a, the sensoready pen is shown with the cap removed. do not remove the cap until you are ready to inject. it is important that you: note: hyrimoz prefilled syringe and injection device are not made with natural rubber latex. how should you store your sensoready pen? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your sensoready pen carton are: not included in your sensoready pen carton are: figure b : items not included in the carton before your injection preparing the sensoready pen figure c : safety checks before injection contact your pharmacist if: figure d : choose your injection site figure e : clean your injection site figure f : remove the cap figure g : hold your pen your injection figure h : start your injection figure i : complete your injection after your injection figure j : check the green indicator figure k : dispose of your used pen manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 10 mg/0.2 ml single-dose prefilled syringe injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe. it is important that you:    note: hyrimoz prefilled syringe is not made with natural rubber latex.   how should you store hyrimoz  single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children.   what do you need for your injection?    included in your prefilled syringe carton is: not included in your hyrimoz prefilled syringe carton are (see figure b ): figure b : items not included in the carton preparing the prefilled syringe    contact your pharmacist if:    figure c : choose your injection site.      figure d : choose your injection site.      figure e : pull the needle cap off.         figure f : pinch the skin and insert the needle.     figure g : press down the plunger.        figure h : dispose of the used prefilled syringe. manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 10 mg/0.1 ml, 20 mg/0.2 ml single-dose prefilled syringe injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe. it is important that you:    note: hyrimoz prefilled syringe is not made with natural rubber latex.   how should you store hyrimoz  single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children.   what do you need for your injection?    included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are (see figure b ): figure b : items not included in the carton preparing the prefilled syringe    contact your pharmacist if:    figure c : choose your injection site.      figure d : clean your injection site.        figure e : pull the needle cap off.         figure f : pinch the skin and insert the needle.     figure g : press down the plunger.        figure h : dispose of the used prefilled syringe. manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners.

ישראל - אנגלית - 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: polysorbate 80; water for injections; mannitol - rheumatoid arthritis: humira 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. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira 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). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira 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: humira 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: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira 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 of infliximab.,ulcerative colitis: humira 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 clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira 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): humira 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: humira 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: mannitol; water for injections; polysorbate 80 - rheumatoid arthritis: humira 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. humira can be used alone or in combination with methotrexate. juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis humira 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). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira 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: - humira 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: - humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older):- humira 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: - humira 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 clinical trials).,psoriasis in adults and children:- humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira 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):- humira 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:- humira 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: polysorbate 80; water for injections; mannitol - rheumatoid arthritis: humira 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. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira 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). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira 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: humira 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: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira 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 of infliximab.,ulcerative colitis: humira 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 clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira 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): humira 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: humira 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: mannitol; polysorbate 80; water for injections - rheumatoid arthritis humira 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. humira can be used alone or in combination with methotrexate.,,juvenile idiopathic arthritis humira 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 antirheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis humira 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 humira 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 humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) humira 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 of infliximab.,ulcerative colitis humira 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 clinical trials).,psoriasis in adults and children humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira 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) humira 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: humira 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: mannitol; polysorbate 80; water for injections - rheumatoid arthritis humira 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. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis humira 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 antirheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis humira 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 humira 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 humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) humira 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 of infliximab.,,ulcerative colitis humira 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 clinical trials).,psoriasis in adults and children humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira 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) humira 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 humira 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - adalimumab, quantity: 20 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita 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. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita 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 amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and old) amgevita 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 of infliximab.,ulcerative colitis amgevita 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.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita 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 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 hidradenitis suppurativa therapy.,uveitis amgevita 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.