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

ucb, inc. - certolizumab pegol (unii: umd07x179e) (certolizumab pegol - unii:umd07x179e) - certolizumab pegol 200 mg in 1 ml - cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (ra). cimzia is indicated for the treatment of adult patients with active psoriatic arthritis (psa). cimzia is indicated for the treatment of adults with active ankylosing spondylitis (as). [see clinical studies (14.4)] cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation [see clinical studies (14.5)]. cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (pso) who are candidates for systemic therapy or phototherapy [see clinical studies (14.6)] cimzia is con

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

glaxosmithkline australia pty ltd - belimumab, quantity: 400 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sucrose; citric acid monohydrate; polysorbate 80 - benlysta is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g. ana titre greater than or equal to 1:80 and/or anti-dsdna titre greater than or equal to 30 iu/ml) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,the safety and efficacy of benlysta have not been evaluated in patients with severe active central nervous system lupus.

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

glaxosmithkline australia pty ltd - belimumab, quantity: 120 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sucrose; citric acid monohydrate; polysorbate 80 - benlysta is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g. ana titre greater than or equal to 1:80 and/or anti-dsdna titre greater than or equal to 30 iu/ml) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,the safety and efficacy of benlysta have not been evaluated in patients with severe active central nervous system lupus.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - belimumab - powder for concentrate for solution for infusion - belimumab 120 mg - belimumab - belimumab - benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g., positive anti-dsdna and low complement) despite standard therapy.benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - belimumab - powder for concentrate for solution for infusion - belimumab 400 mg - belimumab - belimumab - benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g., positive anti-dsdna and low complement) despite standard therapy.benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

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

abbvie pty ltd - adalimumab -

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards.,psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards. psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

fresenius kabi usa, llc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab-aacf 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-aacf can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). adalimumab-aacf 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-aacf can be used alone or in combination with methotrexate. adalimumab-aacf 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-aacf can be used alone or in combination with non-biologic dmards. adalimumab-aacf is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. adalimumab-aacf is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. adalimumab-aacf 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)] . adalimumab-aacf 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. adalimumab-aacf 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)] . adalimumab-aacf is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. adalimumab-aacf is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults. 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 adalimumab-aacf and any potential adverse effects on the breastfed child from adalimumab-aacf or from the underlying maternal condition. the safety and effectiveness of adalimumab-aacf 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 adalimumab-aacf demonstrate that adalimumab-aacf is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, adalimumab-aacf is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero-exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab-aacf have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab-aacf 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-aacf for this indication is supported by adalimumab-aacf'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 adalimumab-aacf 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 adalimumab-aacf in patients 65 years of age and older. in patients treated with adalimumab-aacf, closely monitor for the development of infection or malignancy [see warnings and precautions ( 5.1, 5.2 )] . read this instructions for use before using your adalimumab-aacf prefilled pen. do not try to inject adalimumab-aacf 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 adalimumab-aacf at home, you should receive training on the right way to prepare and inject adalimumab-aacf. it is important that you read, understand, and follow these instructions so that you inject adalimumab-aacf the right way. it is also important to talk to your healthcare provider to be sure you understand your adalimumab-aacf dosing instructions. to help you remember when to inject adalimumab-aacf, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver have any questions about the right way to inject adalimumab-aacf. important information - read the medication guide that comes with your adalimumab-aacf prefilled pen for important information you need to know before using it. - call your healthcare provider if you have any questions about adalimumab-aacf or how to give your injection. - adalimumab-aacf prefilled pen is for single-dose (one-time) use only. - do not share your adalimumab-aacf prefilled pen with another person. you may give another person an infection or get an infection from them. storing adalimumab-aacf prefilled pens - store adalimumab-aacf prefilled pen in the original carton to protect it from light. - store adalimumab-aacf prefilled pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze adalimumab-aacf. do not use adalimumab-aacf if frozen, even if it has been thawed. - refrigerated adalimumab-aacf may be used until the expiration date printed on the adalimumab-aacf carton, dose tray or pen. do not use adalimumab-aacf after the expiration date. - if needed, for example when traveling, adalimumab-aacf prefilled pen can be stored at room temperature between 68°f to 77°f (20°c to 25°c) for up to 28 days. - throw away adalimumab-aacf if it has been kept at room temperature and not been used within 28 days. - record the date you first remove adalimumab-aacf from the refrigerator in the spaces provided on the carton. - throw away (dispose of) the adalimumab-aacf prefilled pen in a sharps disposal container if it has been stored above 77°f (25°c). (see step 7 “dispose of your prefilled pens” ). - do not store adalimumab-aacf in extreme heat or cold. - do not use adalimumab-aacf if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush adalimumab-aacf. - keep the adalimumab-aacf prefilled pen, injection supplies, and all other medicines out of the reach and sight of children. using the adalimumab-aacf prefilled pen - only use adalimumab-aacf prefilled pen if your healthcare provider has instructed you on how to use it. - do not try to reuse the adalimumab-aacf prefilled pen. - before injecting, let adalimumab-aacf sit at room temperature for 15-30 minutes after removing it from the refrigerator. - always inject adalimumab-aacf using the technique your healthcare provider taught you. - do not use an adalimumab-aacf prefilled pen to give adalimumab-aacf to a child who weighs less than 66 pounds (30 kg). - do not insert your fingers into the opening of the safety guard. - do not use the prefilled pen if the new carton is open or damaged. - do not use an adalimumab-aacf prefilled pen that has been frozen or left in direct sunlight. - do not use and do call your healthcare provider or pharmacist if: you drop or crush your adalimumab-aacf prefilled pen. your adalimumab-aacf prefilled pen - you will need the following supplies for each injection of adalimumab-aacf (figure c). find a clean flat surface, such as a table or countertop, in a well-lit area. 1 alcohol swab 1 cotton ball or gauze (not included in your adalimumab-aacf carton) 1 adalimumab-aacf prefilled pen (see figure a) puncture-resistant sharps disposal container for adalimumab-aacf prefilled pen disposal (not included in your adalimumab-aacf carton. (see step 7 “dispose of used prefilled pens ”). - 1 alcohol swab - 1 cotton ball or gauze (not included in your adalimumab-aacf carton) - 1 adalimumab-aacf prefilled pen (see figure a) - puncture-resistant sharps disposal container for adalimumab-aacf prefilled pen disposal (not included in your adalimumab-aacf carton. (see step 7 “dispose of used prefilled pens ”). - place two fingers on the label - pull the pen straight up and out of the packaging (figure f) - place the capped pen on a clean flat surface - do not warm the pen in any other way, such as in a microwave, hot water, or direct sunlight. - do not remove the needle cap until you are ready to inject. - the liquid is clear and colorless to pale yellow, and free of particles and flakes (figure j). - the syringe is not cracked or damaged. (figure j). - the name on the pen says adalimumab-aacf (figure k). - the expiration date (exp:) on the pen has not passed (figure k). do not use the prefilled pen if the label does not have adalimumab-aacf on it or the expiration date has passed. dispose of the pen in your sharps disposal container (see step 7 “dispose of used prefilled pens” ) and call your healthcare provider or pharmacist. - your stomach (abdomen). if you choose your stomach, do not use the area 2 inches around your belly button (navel) or - the front of your thighs (figure l) - do not inject adalimumab-aacf into skin that is sore (tender), bruised, red, hard, scarred or where you have stretch marks or tattoos. - if you have psoriasis, do not inject into any lesions or red, thick, raised or scaly patches. - do not inject through your clothes. - hold the pen upwards. - remove the needle cap with your other hand by pulling the cap straight off (figure n). do not twist the cap. do not insert your fingers into the opening of the safety guard - dispose of the needle cap in your sharps disposal container. - hold the pen so that you can see the transparent syringe housing. - place your thumb above (not touching) the yellow injection button (figure o) - place the pen straight and flat against your skin at a 90° angle (figure p). - push and hold the pen firmly against your skin until the safety guard is fully pushed down. this will unlock the injection button (figure q). - push the injection button with your thumb (figure r). you will hear a loud ‘click’, which means the injection has started. - continue to hold the pen firmly. - watch the syringe plunger to make sure it moves all the way down to the bottom of the transparent syringe housing (figure r). - continue holding the pen for 5 seconds after the syringe plunger has reached the bottom of the transparent syringe housing. (figure s) - lift the pen from your skin (figure t). the safety guard will slide down and lock into place to cover the needle (figure t). - if you do not have a 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. - 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 dispose of 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 manufactured by: fresenius kabi usa, llc lake zurich, illinois 60047 u.s. license no. 2146 this instructions for use has been approved by the u. s. food and drug administration         approved: november/2023

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

celltrion usa, inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab-aaty 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-aaty can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). adalimumab-aaty 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-aaty can be used alone or in combination with methotrexate. adalimumab-aaty 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-aaty can be used alone or in combination with non-biologic dmards. adalimumab-aaty is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. adalimumab-aaty is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. adalimumab-aaty 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)] . adalimumab-aaty 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. adalimumab-aaty 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)] . adalimumab-aaty is indicated for the treatment of moderate to severe hidradenitis suppurativa 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 adalimumab-aaty and any potential adverse effects on the breastfed child from adalimumab-aaty or from the underlying maternal condition. the safety and effectiveness of adalimumab-aaty 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. 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-aaty 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-aaty 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-aaty have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab-aaty 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-aaty for this indication is supported by adalimumab-aaty'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 adalimumab-aaty 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 adalimumab-aaty in patients 65 years of age and older. in patients treated with adalimumab-aaty, 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 adalimumab-aaty 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 adalimumab-aaty 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 adalimumab-aaty 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 adalimumab-aaty 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 adalimumab-aaty 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 adalimumab-aaty 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.