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

mylan specialty l.p. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab-fkjp 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-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). adalimumab-fkjp 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-fkjp can be used alone or in combination with methotrexate . adalimumab-fkjp 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-fkjp can be used alone or in combination with non-biologic dmards. adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. adalimumab-fkjp 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-fkjp 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, 14.8)] . adalimumab-fkjp 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-fkjp 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-fkjp 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. 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-fkjp and any potential adverse effects on the breastfed child from adalimumab-fkjp or from the underlying maternal condition. the safety and effectiveness of adalimumab-fkjp have been established for: pediatric assessments for adalimumab-fkjp demonstrate that adalimumab-fkjp is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, adalimumab-fkjp is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn’s disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn’s disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of adalimumab-fkjp in patients 65 years of age and older. in patients treated with adalimumab-fkjp, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . adalimumab-fkjp pen injection for subcutaneous use 40 mg/0.8 ml single-dose prefilled pen 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 adalimumab-fkjp 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-fkjp at home, you should receive training on the right way to prepare and inject adalimumab-fkjp. it is important that you read, understand, and follow these instructions so that you inject adalimumab-fkjp the right way. it is also important to talk to your healthcare provider to be sure you understand your adalimumab-fkjp dosing instructions. to help you remember when to inject adalimumab-fkjp, 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 adalimumab-fkjp. 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: adalimumab-fkjp pen is for single dose (1-time) use only. important: do not use adalimumab-fkjp if frozen, even if it has been thawed. do not uncap your adalimumab-fkjp pen until you are ready to inject and will not be interrupted. do not recap. recapping your adalimumab-fkjp pen can damage the needle. a loud “click” will occur when the orange activator is pressed down to deliver your dose of adalimumab-fkjp. parts of the adalimumab-fkjp pen storing and handling the adalimumab-fkjp pen if needed, for example when traveling, adalimumab-fkjp 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) adalimumab-fkjp if not used within the 14 day period. record the date on the carton and dose tray when adalimumab-fkjp 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 adalimumab-fkjp carton not included in adalimumab-fkjp 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 adalimumab-fkjp pen dispose of the adalimumab-fkjp 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 adalimumab-fkjp 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 adalimumab-fkjp 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. the logo is a trademark of bgp products operations gmbh, a viatris company. © 2023 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: 06/2023 pci:adalub:ifup:r2 725787 adalimumab-fkjp injection for subcutaneous use 20 mg/0.4 ml and 40 mg/0.8 ml single-dose prefilled syringe 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 adalimumab-fkjp 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-fkjp at home, you should receive training on the right way to prepare and inject adalimumab-fkjp. it is important that you read, understand, and follow these instructions so that you inject adalimumab-fkjp the right way. it is also important to talk to your healthcare provider to be sure you understand your adalimumab-fkjp dosing instructions. to help you remember when to inject adalimumab-fkjp, 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 adalimumab-fkjp. for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) dosage: adalimumab-fkjp prefilled syringe is for single dose (1-time) use only. important: parts of the adalimumab-fkjp prefilled syringe (syringe) see figure a storing and handling the syringe if needed, for example when traveling, adalimumab-fkjp 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) adalimumab-fkjp if not used within the 14-day period. record the date on the carton and dose tray when adalimumab-fkjp 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 adalimumab-fkjp carton (taken from refrigerator 30 minutes prior to intended injection time to allow syringe to reach room temperature) not included in adalimumab-fkjp 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. wait for it to dry on its own, do not fan or blow dry. 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 adalimumab-fkjp 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 adalimumab-fkjp 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 adalimumab-fkjp 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. the logo is a trademark of bgp products operations gmbh, a viatris company. © 2023 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. issued: 06/2023 pci:adalub:ifus:r2 725784

United States - English - 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

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

glaxosmithkline llc - belimumab (unii: 73b0k5s26a) (belimumab - unii:73b0k5s26a) - belimumab 400 mg in 5 ml - benlysta (belimumab) is indicated for the treatment of: limitations of use the efficacy of benlysta has not been evaluated in patients with severe active central nervous system (cns) lupus. use of benlysta is not recommended in this situation. benlysta is contraindicated in patients who have had anaphylaxis with belimumab. pregnancy exposure registry there is a pregnancy exposure registry that evaluates pregnancy outcomes in women with lupus exposed to benlysta during pregnancy. healthcare professionals are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/. risk summary available data on use of benlysta in pregnant women, from observational studies, published case reports, and postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with sle (see clinical considerations) . monoclonal antibodies, such as belimumab, are actively transported 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 animal combined embryo-fetal and pre- and post-natal development study with monkeys that received belimumab by intravenous administration, there was no evidence of fetal harm with exposures approximately 9 times (based on intravenous administration) and 20 times (based on subcutaneous administration) the exposure at the maximum recommended human dose (mrhd). belimumab-related findings in monkey fetuses and/or infants included reductions of b-cell counts, reductions in the density of lymphoid tissue b-lymphocytes in the spleen and lymph nodes, and altered igg and igm titers. the no-adverse-effect-level (noael) was not identified for these findings; however, they were reversible within 3 to 12 months after the drug was discontinued (see data) . based on animal data and the mechanism of action of belimumab, the immune system in infants of treated mothers may be adversely affected. it is unknown, based on available data, whether immune effects, if identified, are reversible [see clinical pharmacology (12.1)]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: pregnant women with sle are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. fetal/neonatal adverse reactions: monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to benlysta in utero. monitor an infant of a treated mother for b-cell reduction and other immune dysfunction [see warnings and precautions (5.5)]. data animal data: in a combined embryo-fetal and pre- and post-natal development study, pregnant cynomolgus monkeys received belimumab at intravenous doses of 0, 5, or 150 mg/kg every 2 weeks from confirmation of pregnancy at gestation days (gd) 20 to 22, throughout the period of organogenesis (up to approximately gd 50), and continuing to either the day of scheduled cesarean section (gd 150 [late third trimester]) or the day of parturition. there was no evidence of maternal toxicity, effects on embryofetal and infant survival, or structural abnormalities at exposure approximately 9 times the mrhd of 10 mg/kg intravenously or 20 times the mrhd of 200 mg subcutaneously (on an auc basis with maternal animal intravenous doses up to 150 mg/kg). belimumab-related findings in mothers included reductions of immature and mature b-cell counts and in fetuses and/or infants included reductions of immature and mature b-cell counts, reductions in the density of lymphoid tissue b-lymphocytes in the spleen and lymph nodes, reduced spleen weights, increased igg titers, and reduced igm titers. b-cell counts in infant monkeys exposed to belimumab in utero recovered by 3 months of age and in mothers after 1 year. igg and igm levels in infant monkeys recovered by 6 months of age and the reductions in b-lymphocytes in the lymph nodes and spleen were reversed by 1 year of age. belimumab crossed the placenta, as it was detected in fetal cord blood and amniotic fluid on gd 150. risk summary no information is available on the presence of belimumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. belimumab was detected in the milk of cynomolgus monkeys; however, due to species-specific differences in lactation physiology, animal data may not predict drug levels in human milk. maternal igg is known to be present in human milk. if belimumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to belimumab are unknown. the lack of clinical data during lactation precludes clear determination of the risk of benlysta to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for benlysta, and any potential adverse effects on the breastfed child from benlysta or from the underlying maternal condition. contraception following an assessment of benefit versus risk, if prevention of pregnancy is warranted, females of reproductive potential should use effective contraception during treatment and for at least 4 months after the final treatment. safety and effectiveness of benlysta have been established for the treatment of sle and lupus nephritis in pediatric patients 5 to 17 years old. use of benlysta in pediatric patients with sle is supported by evidence from pharmacokinetic (pk) and efficacy results from a pediatric study (trial 6), as well as pk exposure and extrapolation of the established efficacy of benylsta plus standard therapy from the phase 3 intravenous studies in adults with sle. a randomized, double‑blind, placebo‑controlled, pk, efficacy, and safety study (trial 6) to evaluate intravenously administered benlysta 10 mg/kg plus standard therapy compared with placebo plus standard therapy over 52 weeks was conducted in 93 pediatric patients with sle. the proportion of pediatric patients achieving an sri-4 response was higher in patients receiving benlysta plus standard therapy compared with placebo plus standard therapy. pediatric patients receiving benlysta plus standard therapy also had a lower risk of experiencing a severe flare compared with placebo plus standard therapy [see clinical studies (14.3)] . pharmacokinetics were evaluated in a total of 53 pediatric patients with sle and were consistent with the adult population with sle [see clinical pharmacology (12.3)] . use of benlysta in pediatric patients with active lupus nephritis is based on the extrapolation of efficacy from the intravenous study in adults (n = 224) with active lupus nephritis, and supported by pharmacokinetic data from intravenous studies in adults (n = 224) with active lupus nephritis and from pediatric patients (n = 53) with sle. estimated belimumab exposures for pediatric patients were comparable to adults with active lupus nephritis [see clinical pharmacology (12.3)] . the safety and effectiveness of intravenous administration of benlysta have not been established in pediatric patients younger than 5 years of age. the safety and effectiveness of subcutaneous administration of benlysta have not been established in pediatric patients younger than 18 years of age. clinical studies of benlysta did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects. use with caution in geriatric patients. the safety and efficacy of benlysta were evaluated in studies that included patients with sle who had mild (creatinine clearance [crcl] ≥60 and <90 ml/min), moderate (crcl ≥30 and <60 ml/min), or severe (crcl ≥15 and <30 ml/min) renal impairment. no dosage adjustment is recommended in patients with renal impairment. no formal trials were conducted to examine the effects of hepatic impairment on the pharmacokinetics of belimumab. no dosage adjustment is recommended in patients with hepatic impairment. in trial 2 and trial 3 (intravenous dosing), sle responder index-4 (sri-4) response rates were lower for black patients receiving benlysta plus standard therapy relative to black patients receiving placebo plus standard therapy [see clinical studies (14.1)] . in trial 4 (intravenous dosing), a 2:1 randomized, placebo-controlled trial in black patients, sle responder index (sri-s2k) response rates were higher for black patients receiving benlysta plus standard therapy (49%) relative to black patients receiving placebo plus standard therapy (42%). however, the treatment difference was not statistically significant [see clinical studies (14.1)] . in trial 7 (subcutaneous dosing), sri-4 response was 45% (26/58) in black patients receiving benlysta plus standard therapy compared with 39% (13/33) in black patients receiving placebo plus standard therapy [see clinical studies (14.4)] . the safety profile of benlysta in black patients was consistent with the known safety profile of benlysta administered in the overall population [see adverse reactions (6.1)] . instructions for use benlysta (ben-list-ah) (belimumab) injection, for subcutaneous use prefilled syringe read this instructions for use before you start to use benlysta and each time you refill your prescription. there may be new information. you should also receive training from your healthcare provider on how to use the prefilled syringe the right way. if you do not follow these instructions the prefilled syringe may not work properly. benlysta is for use under the skin only (subcutaneous). important storage information important warnings benlysta prefilled syringe parts before use after use – needle is covered by needle guard supplies needed for the injection benlysta prefilled syringe alcohol swab (not included) gauze pad or cotton ball (not included) sharps container (not included) 1 gather and check supplies gather supplies check expiration date 2 prepare and inspect the benlysta prefilled syringe allow to come to room temperature inspect benlysta solution 3 choose and clean the injection site choose the injection site clean the injection site 4 prepare for the injection remove the needle cap 5 inject benlysta insert the needle complete the injection 6 dispose of used prefilled syringe and inspect dispose of the used prefilled syringe throw away (dispose of) the used syringe and needle cap in a sharps container. see figure j. inspect the injection site additional information for more information about benlysta, go to www.benlysta.com or call 1-877-423-6597. this instructions for use has been approved by the u.s. food and drug administration. trademarks are owned by or licensed to the gsk group of companies. manufactured by glaxosmithkline llc philadelphia, pa 19104, u.s. license no. 1727, and distributed by glaxosmithkline durham, nc 27701 ©2022 gsk group of companies or its licensor. bnl:5ifu-s revised july 2022 instructions for use benlysta (ben-list-ah) (belimumab) injection, for subcutaneous use prefilled autoinjector read this instructions for use before you start to use benlysta and each time you refill your prescription. there may be new information. you should also receive training from your healthcare provider on how to use the autoinjector the right way. if you do not follow these instructions the autoinjector may not work properly. benlysta is for use under the skin only (subcutaneous). important storage information important warnings benlysta autoinjector parts supplies needed for the injection benlysta autoinjector alcohol swab (not included) gauze pad or cotton ball (not included) sharps container (not included) 1 gather and check supplies gather supplies check expiration date 2 prepare and inspect the benlysta autoinjector allow to come to room temperature inspect benlysta solution 3 choose and clean the injection site choose the injection site clean the injection site 4 prepare for the injection remove the ring cap position the autoinjector 5 inject benlysta start the injection complete the injection 6 dispose of used autoinjector and inspect dispose of the used autoinjector throw away (dispose of) the used autoinjector and ring cap in a sharps container. see figure k. inspect the injection site additional information for more information about benlysta, go to www.benlysta.com or call 1-877-423-6597. this instructions for use has been approved by the u.s. food and drug administration. trademarks are owned by or licensed to the gsk group of companies. manufactured by glaxosmithkline llc philadelphia, pa 19104, u.s. license no. 1727, and distributed by glaxosmithkline durham, nc 27701 ©2022 gsk group of companies or its licensor. bnl:5ifu-a revised july 2022

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

janssen biotech, inc. - golimumab (unii: 91x1klu43e) (golimumab - unii:91x1klu43e) - golimumab 50 mg in 4 ml - simponi aria, in combination with methotrexate (mtx), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. simponi aria is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. simponi aria is indicated for the treatment of adult patients with active ankylosing spondylitis. simponi aria is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pjia) in patients 2 years of age and older. none. risk summary there are no adequate and well-controlled trials of simponi aria in pregnant women. monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. there are clinical considerations for the use of simponi aria in pregnant women [see clinical considerations] . in an animal reproductive study, golimumab administered by the subcutaneous route to pregnant mo

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

abbvie inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab 40 mg in 0.8 ml - humira 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. humira can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards).  humira is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. humira can be used alone or in combination with methotrexate. humira is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. humira can be used alone or in combination with non-biologic dmards. humira is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. humira is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older. humira is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. limitations of use the effectiveness of humira has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies ( 14.7 , 14.8 )] . humira 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. humira 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 ) ] . humira is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. humira is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. 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 humira pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn’s disease (cd). 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 humira 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 humira, 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 humira was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 µg/ml in cord blood, 4.28-17.7 µg/ml in infant serum, and 0-16.1 µg/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 µg/ml), 7 weeks (1.31 µg/ml), 8 weeks (0.93 µg/ml), and 11 weeks (0.53 µg/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 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 humira and any potential adverse effects on the breastfed child from humira or from the underlying maternal condition. the safety and effectiveness of humira 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. - the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. - the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. - the treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older. due to its inhibition of tnfα, humira administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to humira 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 humira [see warnings and precautions ( 5.2 ) ] . juvenile idiopathic arthritis in study jia-i, humira 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 ) ] . humira has 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 humira 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 humira have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of humira 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 humira 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 humira 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 humira have not been established in pediatric patients with crohn’s disease less than 6 years of age. pediatric ulcerative colitis the safety and effectiveness of humira for the treatment of moderately to severely active ulcerative colitis have been established in pediatric patients 5 years of age and older. use of humira 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 humira in 93 pediatric patients (5 years to 17 years of age) [see adverse reactions ( 6.1 ) , clinical pharmacology ( 12.3 ) , clinical studies ( 14.8 ) ] . the adverse reaction profile in patients 5 years to 17 years of age was similar to adults. the effectiveness of humira has not been established in patients who have lost response or were intolerant to tnf blockers. the safety and effectiveness of humira have not been established in pediatric patients with ulcerative colitis less than 5 years of age. pediatric uveitis the safety and effectiveness of humira for the treatment of non-infectious uveitis have been established in pediatric patients 2 years of age and older. the use of humira is supported by evidence from adequate and well-controlled studies of humira in adults and a 2:1 randomized, controlled clinical study in 90 pediatric patients [see clinical studies ( 14.12 ) ] . the safety and effectiveness of humira have not been established in pediatric patients with uveitis less than 2 years of age. hidradenitis suppurativa use of humira in pediatric patients 12 years of age and older for hs is supported by evidence from adequate and well-controlled studies of humira in adult hs patients. additional population pharmacokinetic modeling and simulation predicted that weight-based dosing of humira in pediatric patients 12 years of age and older can provide generally similar exposure to adult hs patients. the course of hs is sufficiently similar in adult and adolescent patients to allow extrapolation of data from adult to adolescent patients. the recommended dosage in pediatric patients 12 years of age or older is based on body weight [see dosage and administration ( 2.6 ) , clinical pharmacology ( 12.3 ) , and clinical studies ( 14.10 ) ] . the safety and effectiveness of humira have not been established in patients less than 12 years of age with hs. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received humira 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 humira 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 humira in patients 65 years of age and older. in patients treated with humira, closely monitor for the development of infection or malignancy [see warnings and precautions ( 5.1 , 5.2 )] . instructions for use humira ® (hu-mare-ah) (adalimumab) 40 mg/0.8 ml single-dose pen do not try to inject humira yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your doctor decides that you or a caregiver may be able to give your injections of humira at home, you should receive training on the right way to prepare and inject humira. it is important that you read, understand, and follow these instructions so that you inject humira the right way. it is also important to talk to your doctor to be sure you understand your humira dosing instructions. to help you remember when to inject humira, 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 humira.  important: - do not use humira if frozen, even if it has been thawed. - the humira pen contains glass. do not drop or crush the pen because the glass inside may break. - each humira pen has 2 caps on it. do not remove the gray cap (cap #1) or the plum-colored cap (cap #2) until right before your injection. - when the plum-colored button on the humira pen is pressed to give your dose of humira, you will hear a loud “click” sound. you must practice injecting humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home. the loud click sound means the start of the injection. you will know that the injection has finished when the yellow indicator appears fully in the window view and stops moving. - you must practice injecting humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home. - the loud click sound means the start of the injection. - you will know that the injection has finished when the yellow indicator appears fully in the window view and stops moving. see the section below called “prepar ing the humira pen” . gather the supplies for your injection - you will need the following supplies for each injection of humira. find a clean, flat surface to place the supplies on. 1 alcohol swab 1 cotton ball or gauze pad (not included in your humira carton) 1 humira pen (see figure a) puncture-resistant sharps disposal container for humira pen disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used humira pen?” section at the end of this instructions for use. - 1 alcohol swab - 1 cotton ball or gauze pad (not included in your humira carton) - 1 humira pen (see figure a) - puncture-resistant sharps disposal container for humira pen disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used humira pen?” section at the end of this instructions for use. if more comfortable, take your humira pen out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. do not remove the gray cap (cap #1) or the plum-colored cap (cap #2) while allowing it to reach room temperature. do not warm humira in any other way (for example, do not warm it in a microwave or in hot water). if you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. the figure below shows what the humira pen looks like. see figure a. figure a check the carton, dose tray, and humira pen . 1. make sure the name humira appears on the carton, dose tray, and humira pen label. 2. do not use and do call your doctor or pharmacist if: - you drop or crush your humira pen. - the seals on the top or bottom of the carton are broken or missing. - the expiration date on the carton, dose tray, and pen has passed. - the humira pen has been frozen or left in direct sunlight. - humira has been kept at room temperature for longer than 14 days or humira has been stored above 77°f (25°c). see the “how should i store humira?” section at the end of this instructions for use. 3. hold the pen with the gray cap (cap # 1) pointed down. 4. make sure the amount of liquid in the pen is at the fill line or close to the fill line seen through the window. this is the full dose of humira that you will inject. see figure b. 5. if the pen does not have the full amount of liquid, do not use that pen . call your pharmacist. figure b 6. turn the pen over and hold the pen with the gray cap (cap # 1) pointed up. see figure c. 7. check the solution through the windows on the side of the pen to make sure the liquid is clear and colorless. do not use your humira pen if the liquid is cloudy, discolored, or if it has flakes or particles in it. call your pharmacist. it is normal to see one or more bubbles in the window. figure c choose the injection site 8. wash and dry your hands well. 9. choose an injection site on: - the front of your thighs or - your lower abdomen (belly). if you choose your abdomen, do not use the area 2 inches around your belly button (navel). see figure d. figure d - choose a different site each time you give yourself an injection. each new injection should be given at least one inch from a site you used before. - do not inject humira into skin that is: sore (tender) bruised red hard scarred or where you have stretch marks - sore (tender) - bruised - red - hard - scarred or where you have stretch marks - 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. prepare the injection site 10. wipe the injection site with an alcohol prep (swab) using a circular motion. - do not touch this area again before giving the injection. allow the skin to dry before injecting. do not fan or blow on the clean area. preparing the humira pen 11. do not remove the gray cap (cap # 1) or the plum-colored cap (cap # 2) until right before your injection. 12. hold the middle of the pen (gray body) with one hand so that you are not touching the gray cap (cap # 1) or the plum-colored cap (cap # 2). turn the pen so that the gray cap (cap # 1) is pointing up. see figure e. figure e 13. with your other hand, pull the gray cap (cap # 1) straight off (do not twist the cap). make sure the small needle cover of the syringe has come off with the gray cap (cap # 1). see figure f. 14. throw away the gray cap (cap # 1). figure f - do not put the gray cap (cap # 1) back on the pen. putting the gray cap (cap # 1) back on may damage the needle. - the white needle sleeve, which covers the needle, can now be seen. - do not touch the needle with your fingers or let the needle touch anything. - you may see a few drops of liquid come out of the needle. this is normal. 15. remove the plum-colored cap (cap # 2) from the bottom of the pen by pulling it straight off (do not twist the cap). the pen is now activated. throw away the plum-colored cap (cap # 2). - do not put the plum-colored cap (cap # 2) back on the pen because it could cause medicine to come out of the syringe. the plum-colored activator button: - turn the pen so the plum-colored activator button is pointed up. see figure g. figure g - do not press the plum-colored activator button until you are ready to inject humira. pressing the plum-colored activator button will release the medicine from the pen. - hold the pen so that you can see the window. see figure h. it is normal to see one or more bubbles in the window. figure h position the pen and inject humira 16. position the pen: - squeeze the area of the cleaned skin and hold it firmly until the injection is complete. see figure i. you will inject into this raised area of skin. figure i 17. place the white end of the pen straight (at a 90º angle ) and flat against the raised area of your skin that you are squeezing. place the pen so that it will not inject the needle into your fingers that are holding the raised skin. see figure j. figure j 18. inject humira - it is important that you firmly push the pen down all the way against the injection site before starting the injection. - keep pushing down to prevent the pen from moving away from the skin during the injection. - press the plum-colored activator button with your thumb to begin the injection. try not to cover the window. see figure k. figure k - you will hear a loud ‘click’ when you press the plum-colored activator button. the loud click means the start of the injection. - keep pressing the plum-colored activator button and continue to push the pen against your squeezed, raised skin until all the medicine is injected. this can take up to 10 seconds, so count slowly to ten. keep pushing the pen against the squeezed, raised skin of your injection site for the whole time so you get the full dose of medicine. - you will know that the injection has finished when the yellow indicator fully appears in the window view and stops moving. see figure l. figure l 19. when the injection is finished, slowly pull the pen from your skin. the white needle sleeve will move to cover the needle tip. see figure m. - do not touch the needle. the white needle sleeve is there to prevent you from touching the needle. figure m - there may be a small amount of liquid on the injection site. this is normal. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. 20. throw away (dispose of) your used humira pen in a sharps disposal container right away after use. see the section “how should i dispose of the used humira pen?” 21. keep a record of the dates and location of your injection sites. to help you remember when to take humira, you can mark your calendar ahead of time. how should i throw away ( dispose of ) the used humira pen? - put your pen in a fda-cleared sharps disposal container right away after use. see figure n. do not throw away the pen in your household trash.   - do not try to touch the needle. the white needle sleeve is there to prevent you from touching the needle. figure n - 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 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. - for the safety and health of you and others, never re-use your humira pens. - the used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash. - 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.   - always keep the sharps container out of the reach of children. how should i store humira? - store humira in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). store humira in the original carton until use to protect it from light. - do not freeze humira. do not use humira if frozen, even if it has been thawed. - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. do not use humira after the expiration date. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. store humira in the original carton until use to protect it from light. - throw away humira if it has been kept at room temperature and not been used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not use a pen if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush humira. - keep humira, injection supplies, and all other medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: abbvie inc. north chicago, il 60064, u.s.a. us license number 1889 20066944 revised: 02/2021  - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the pen has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the gray cap (cap #1) or plum-colored cap (cap #2) while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water. - do not use the pen if liquid has been frozen (even if thawed) - 1 single-dose pen and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your humira pen - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - it is normal to see 1 or more bubbles in the window - make sure the liquid is clear and colorless - do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it - do not use the pen if it has been dropped or crushed - it is normal to see a few drops of liquid come out of the needle - a loud “click” will signal the start of the injection - keep pushing the pen down firmly against the injection site until the injection is complete - injection is complete when the yellow indicator has stopped moving - a small amount of liquid on the injection site is normal - do not rub - slight bleeding at the injection site is normal - put your used needles, pens, and sharps in a fda cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles, syringes, and the pen in the household trash. - 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 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. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - the yellow indicator has stopped moving. this takes up to 10 seconds.  - call 1-800-4humira (1-800-448-6472) for help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the pen has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or pen. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the gray cap (cap #1) or plum-colored cap (cap #2) while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water - do not use the pen if liquid has been frozen (even if thawed) - 1 single-dose pen and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your humira pen - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - it is normal to see 1 or more bubbles in the window - make sure the liquid is clear and colorless - do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it - do not use the pen if it has been dropped or crushed - it is normal to see a few drops of liquid come out of the needle - a loud “click” will signal the start of the injection - keep pushing the pen down firmly against the injection site until the injection is complete - injection is complete when the yellow indicator has stopped moving - a small amount of liquid on the injection site is normal - do not rub - slight bleeding at the injection site is normal - put your used needles, pens, and sharps in a fda cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles, syringes, and the pen in the household trash. - 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 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. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - the yellow indicator has stopped moving. this takes up to 15 seconds.  - call 1-800-4humira (1-800-448-6472) for help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container instructions for use humira ® (hu-mare-ah) (adalimumab) 40 mg/0.8 ml, 20 mg/0.4 ml and 10 mg/0.2 ml single-dose prefilled syringe do not try to inject humira yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your doctor decides that you or a caregiver may be able to give your injections of humira at home, you should receive training on the right way to prepare and inject humira. it is important that you read, understand, and follow these instructions so that you inject humira the right way. it is also important to talk to your doctor to be sure you understand your humira dosing instructions. to help you remember when to inject humira, 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 humira. gather the supplies for your injection - you will need the following supplies for each injection of humira. find a clean, flat surface to place the supplies on. ● 1 alcohol swab ● 1 cotton ball or gauze pad (not included in your humira carton) ● 1 humira prefilled syringe (see figure a) ● puncture-resistant sharps disposal container for humira prefilled syringe disposal (not included in your humira carton). see the “how should i throw away (dispose of) the used prefilled syringes and needles?” section at the end of this instructions for use. if more comfortable, take your humira prefilled syringe out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. do not remove the needle cover while allowing it to reach room temperature. do not warm humira in any other way (for example, do not warm it in a microwave or in hot water). if you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. the figure below shows what a prefilled syringe looks like. see figure a. figure a check the carton, dose tray, and prefilled syringe 1. make sure the name humira appears on the dose tray and prefilled syringe label. 2. do not use and do call your doctor or pharmacist if: - the seals on top or bottom of the carton are broken or missing. - the humira labeling has an expired date. check the expiration date on your humira carton and do not use if the date has passed. - the prefilled syringe has been frozen or left in direct sunlight. - humira has been kept at room temperature for longer than 14 days or humira has been stored above 77°f (25°c). - the liquid in the prefilled syringe is cloudy, discolored or has flakes or particles in it. make sure the liquid is clear and colorless. see the “how should i store humira?” section at the end of this instructions for use. choose the injection site 3. wash and dry your hands well. 4. choose an injection site on: - the front of your thighs or - your lower abdomen (belly). if you choose your abdomen, do not use the area 2 inches around your belly button (navel). see figure b. figure b - choose a different site each time you give yourself an injection. each new injection should be given at least one inch from a site you used before. - do not inject into skin that is: sore (tender) bruised red hard scarred or where you have stretch marks - sore (tender) - bruised - red - hard - scarred or where you have stretch marks - 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. prepare the injection site 5. wipe the injection site with an alcohol prep (swab) using a circular motion. 6. do not touch this area again before giving the injection. allow the skin to dry before injecting. do not fan or blow on the clean area. prepare the syringe and needle 7. check the fluid level in the syringe: - hold the syringe with the covered needle pointing down. see figure c. figure c - hold the syringe at eye level. look closely to make sure that the amount of liquid in the syringe is the same or close to the: 0.8 ml line for the 40 mg prefilled syringe. see figure d. 0.4 ml line for the 20 mg prefilled syringe. see figure d. 0.2 ml line for the 10 mg prefilled syringe. see figure d. - 0.8 ml line for the 40 mg prefilled syringe. see figure d. - 0.4 ml line for the 20 mg prefilled syringe. see figure d. - 0.2 ml line for the 10 mg prefilled syringe. see figure d. figure d 8. the top of the liquid may be curved. if the syringe does not have the correct amount of liquid, do not use that syringe . call your pharmacist. 9. remove the needle cover: - hold the syringe in one hand. with the other hand gently remove the needle cover. see figure e. - throw away the needle cover. figure e - do not touch the needle with your fingers or let the needle touch anything. 10. turn the syringe so the needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. using your other hand, slowly push the plunger in to push the air out through the needle. see figure f. figure f - you may see a drop of liquid at the end of the needle. this is normal. position the prefilled syringe and inject humira position the syringe 11. hold the body of the prefilled syringe in one hand between the thumb and index finger. hold the syringe in your hand like a pencil. see figure g. figure g - do not pull back on the plunger at any time. - with your other hand, gently squeeze the area of the cleaned skin and hold it firmly. see figure h. figure h inject humira 12. using a quick, dart-like motion, insert the needle into the squeezed skin at about a 45-degree angle . see figure i. figure i - after the needle is in, let go of the skin. pull back gently on the plunger. if blood appears in the syringe: - it means that you have entered a blood vessel. - do not inject humira. - pull the needle out of the skin while keeping the syringe at the same angle. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. see figure j. figure j - do not use the same syringe and needle again. throw away the needle and syringe in your sharps container. - do not rub the injection site. you may have slight bleeding. this is normal. - repeat steps 1 through 12 with a new prefilled syringe. if no blood appears in the syringe: - slowly push the plunger all the way in until all the liquid is injected and the syringe is empty. - pull the needle out of the skin while keeping the syringe at the same angle. - press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. do not rub the injection site. you may have slight bleeding. this is normal. 13. throw away the used prefilled syringe and needle in a sharps disposal container right away after use. see “how should i throw away ( dispose of ) used prefilled syringes and needles?” 14. keep a record of the dates and location of your injection sites. to help you remember when to take humira, you can mark your calendar ahead of time. how should i throw away ( dispose of ) used prefilled syringes and needles? - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. see figure k. do not throw away (dispose of) loose needles and syringes in your household trash.   - do not try to touch the needle. figure k - 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 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. - for the safety and health of you and others, needles and used syringes must never be re-used. - the used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash. - 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. - always keep the sharps container out of the reach of children. how should i store humira? - store humira in the refrigerator between 36ºf to 46ºf (2ºc to 8ºc). store humira in the original carton until use to protect it from light. - do not freeze humira. do not use humira if frozen, even if it has been thawed. - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or prefilled syringe. do not use humira after the expiration date. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. store humira in the original carton until use to protect it from light. - throw away humira if it has been kept at room temperature and not been used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not use a prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. - do not drop or crush humira. the prefilled syringe is glass. - keep humira, injection supplies, and all other medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: abbvie inc. north chicago, il 60064, u.s.a. us license number 1889 20066947 revised: 02/2021  - liquid is cloudy, discolored, or has flakes or particles in it - expiration date has passed - liquid has been frozen (even if thawed) or left in direct sunlight - the prefilled syringe has been dropped or crushed - store humira in the refrigerator between 36°f to 46°f (2°c to 8°c). - store humira in the original carton until use to protect it from light. - do not freeze - refrigerated humira may be used until the expiration date printed on the humira carton, dose tray or prefilled syringe. - if needed, for example when you are traveling, you may also store humira at room temperature up to 77°f (25°c) for up to 14 days. - throw away humira if it has been kept at room temperature and not used within 14 days. - record the date you first remove humira from the refrigerator in the spaces provided on the carton and dose tray. - do not store humira in extreme heat or cold. - do not remove the needle cover while allowing humira to reach room temperature - do not warm humira in any other way. for example, do not warm it in a microwave or in hot water. - do not use the prefilled syringe if liquid has been frozen (even if thawed) - 1 single-dose prefilled syringe and alcohol swab - 1 cotton ball or gauze pad (not included) - puncture-resistant sharps disposal container (not included). see step 9 at the end of this instructions for use for instructions on how to throw away (dispose of) your prefilled syringe - on the front of your thighs or - your abdomen (belly) at least 2 inches from your navel (belly button) - different from your last injection site - do not inject through clothes - do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques - throw the needle cover away - do not touch the needle with your fingers or let the needle touch anything - hold the prefilled syringe at eye level with one hand so you can see the air in the prefilled syringe - using your other hand, slowly push the plunger in to push the air out through the needle. - you may see a drop of liquid at the end of the needle. this is normal. - after the needle is in, let go of the skin. - do not rub - slight bleeding at the injection site is normal - put your used needles, syringes, and sharps in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in the household trash. - 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 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. - call your healthcare provider or 1-800-4humira (1-800-448-6472) or visit www.humira.com if you need help - call 1-800-4humira (1-800-448-6472) for a free fda-cleared sharps disposal container

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

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; histidine; polysorbate 80; water for injections - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; polysorbate 80; water for injections; histidine - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; water for injections; sorbitol - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: polysorbate 80; water for injections; histidine; sorbitol - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial

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

janssen biotech, inc. - golimumab (unii: 91x1klu43e) (golimumab - unii:91x1klu43e) - golimumab 50 mg in 0.5 ml - simponi, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. simponi, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis. simponi is indicated for the treatment of adult patients with active ankylosing spondylitis. simponi is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for: - inducing and maintaining clinical response - improving endoscopic appearance of the mucosa during induction - inducing clinical remission - achieving and sustaining clinical remission in induction responders [see clinical studies (14.4)]. none. risk summary there are no adequate and well-controlled trials of simponi in pregnant women. monocl