USA - engelsk - NLM (National Library of Medicine)

a-s medication solutions - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - amjevita is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. amjevita can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). amjevita is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. amjevita can be used alone or in combination with methotrexate. amjevita is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. amjevita can be used alone or in combination with non-biologic dmards. amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. amjevita is indicated for the treatment of mod

USA - engelsk - NLM (National Library of Medicine)

a-s medication solutions - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - amjevita is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. amjevita can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). amjevita is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. amjevita can be used alone or in combination with methotrexate. amjevita is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. amjevita can be used alone or in combination with non-biologic dmards. amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. amjevita is indicated for the treatment of mod

USA - engelsk - 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.

USA - engelsk - NLM (National Library of Medicine)

merck sharp & dohme corp. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - hadlima 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. hadlima can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). hadlima is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. hadlima can be used alone or in combination with methotrexate. hadlima is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. hadlima can be used alone or in combination with non-biologic dmards. hadlima is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. hadlima is indicated for reducing signs and symptoms

USA - engelsk - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - cyltezo 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. cyltezo can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). cyltezo is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. cyltezo can be used alone or in combination with methotrexate. cyltezo is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. cyltezo can be used alone or in combination with non-biologic dmards. cyltezo is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. cyltezo is indicated for the treatment of moderately

USA - engelsk - NLM (National Library of Medicine)

sandoz inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab 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. adalimumab can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). adalimumab is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. adalimumab can be used alone or in combination with methotrexate. adalimumab is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. adalimumab can be used alone or in combination with non-biologic dmards. adalimumab is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. adalimumab is indicated for the

USA - engelsk - NLM (National Library of Medicine)

fresenius kabi usa, llc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - idacio 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. idacio can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). idacio is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. idacio can be used alone or in combination with methotrexate. idacio is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. idacio can be used alone or in combination with non-biologic dmards. idacio is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. idacio is indicated for the treatment of moderately to sever

USA - engelsk - NLM (National Library of Medicine)

organon llc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - hadlima 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. hadlima can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). hadlima is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. hadlima can be used alone or in combination with methotrexate. hadlima is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. hadlima can be used alone or in combination with non-biologic dmards. hadlima is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. hadlima is indicated for the treatment of moderately

USA - engelsk - NLM (National Library of Medicine)

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

USA - engelsk - NLM (National Library of Medicine)

coherus biosciences inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - yusimry 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. yusimry can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). yusimry is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. yusimry can be used alone or in combination with methotrexate. yusimry is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. yusimry can be used alone or in combination with non-biologic dmards. yusimry is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. yusimry is indicated for the treatment of moderately