États-Unis - anglais - NLM (National Library of Medicine)

mirum pharmaceuticals inc. - maralixibat chloride (unii: v78m04f0xc) (maralixibat - unii:uyb6uof69l) - livmarli® is indicated for the treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (algs). livmarli is indicated for the treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (pfic). limitations of use: livmarli is not recommended in a subgroup of pfic type 2 patients with specific abcb11 variants resulting in non-functional or complete absence of bile salt export pump (bsep) protein [see clinical studies (14.2)] . livmarli is contraindicated in patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) [see warnings and precautions (5.1)] . risk summary maternal use at the recommended clinical dose of livmarli is not expected to result in measurable fetal exposure because systemic absorption following oral administration is low [see clinical pharmacology (12.3)]. maralixibat may inhibit the absorption of fat-soluble vitamins [see warnings and precautions (5.3) and clinical considerations] . in animal reproduction studies, no developmental effects were observed (see data) . the estimated background risk of major birth defects for algs is higher than the general population because algs is an autosomal dominant condition. the background risk of miscarriage for algs is unknown. the background risk of birth defects and miscarriage for pfic is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions maralixibat may inhibit the absorption of fat-soluble vitamins (fsv). monitor for fsv deficiency and supplement as needed. increased supplementation of fsvs may be needed during pregnancy [see warnings and precautions (5.3)] . data animal data no effects on embryo-fetal development were observed in pregnant rats treated orally with up to 1000 mg/kg/day (approximately 3300 to 12000 times the maximum recommended dose based on auc [area under the plasma concentration-time curve]) or in pregnant rabbits treated orally with up to 250 mg/kg/day (approximately 1200 to 4700 times the maximum recommended dose based on auc) during the period of organogenesis. no effects on postnatal development were observed in a pre- and postnatal development study, in which female rats were treated orally with up to 750 mg/kg/day during organogenesis through lactation. maternal systemic exposure to maralixibat at the maximum dose tested was approximately 2500 to 9400 times the maximum recommended dose based on auc. risk summary livmarli has low absorption following oral administration, and breastfeeding is not expected to result in exposure of the infant to livmarli at the recommended dose [see clinical pharmacology (12.3)] . there are no data on the presence of livmarli in human milk, the effects on the breastfed infant, or the effects on milk production. patients with algs or pfic can have fsv deficiency as part of their disease. maralixibat may reduce absorption of fat-soluble vitamins [see warnings and precautions (5.3)] . monitor fsv levels and supplement fsv intake, if fsv deficiency is observed during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother's need for livmarli and any potential adverse effects on the breastfed child from livmarli or from the underlying maternal condition. algs the safety and effectiveness of livmarli for the treatment of cholestatic pruritus in alagille syndrome have been established in pediatric patients aged 3 months of age and older. use of livmarli in this population is supported by evidence from a study of patients 1 to 15 years of age (n=31) that included 18 weeks of open-label treatment followed by a 4 week placebo-controlled randomized withdrawal period and a subsequent 26-week open-label treatment period. additional safety information was obtained from four studies in patients up to 21 years of age (n=55) [see adverse reactions (6) and clinical studies (14.1)] . use of livmarli in patients 3 to <12 months of age is supported by an open-label, multicenter study of livmarli which showed a similar safety, tolerability and pharmacokinetic profile to patients with algs ≥12 months of age. the safety and effectiveness of livmarli have not been established in patients with algs less than 3 months of age. pfic the safety and effectiveness of livmarli for the treatment of cholestatic pruritus in pfic have been established in pediatric patients aged 5 years of age and older. use of livmarli in this population is supported by evidence from trial 2 in patients 1 to <18 years of age that included 26 weeks of placebo-controlled safety and efficacy data [see adverse reactions (6) and clinical studies (14.2)] . the safety and effectiveness of livmarli have not been established in patients with pfic younger than 12 months of age. the safety and effectiveness of livmarli for the treatment of pruritus in algs or pfic in adult patients, 65 years of age and older, have not been established. clinical studies of livmarli included algs or pfic patients with impaired hepatic function at baseline. the efficacy and safety in algs or pfic patients with clinically significant portal hypertension and in patients with decompensated cirrhosis have not been established. livmarli is contraindicated in patients with prior or active hepatic decompensation events [see dosage and administration (2.5), contraindications (4), warnings and precautions (5.1), and clinical studies (14)] . - before you give livmarli for the first time, talk to your healthcare provider or pharmacist about how to correctly measure your prescribed dose. - you may be given 1 or more dosing dispensers of different sizes as shown in table 1 below. always use the correct dosing dispenser size provided with livmarli based on your current prescribed dose. - your prescribed dose may change over time. use the table above to choose the correct dosing dispenser size for your prescribed dose. - if you do not have the correct dosing dispenser size for your prescribed dose, contact your healthcare provider or pharmacist. - the dosing dispenser may be used for 100 days if cleaned correctly (see section c). after 100 days, replace the dosing dispenser with a new one. a new replacement dosing dispenser may be used within the 100 days if necessary. - do not use a household teaspoon or any other dosing device to measure the dose. - do not open more than 1 bottle at a time. - do not give more than the prescribed dose. - do not use livmarli after 100 days of first opening the bottle or after the throw away (discard) date listed on the pharmacy label (see section d). - when you start a new bottle of livmarli, use a new dosing dispenser. - store unopened livmarli at room temperature, between 68°f and 77°f (20°c and 25°c). - after opening the livmarli bottle, store below 86°f (30°c). - store the dosing dispenser in a clean, dry place when not in use. livmarli (9.5 mg/ml):                                          figure a                                          figure b                                                  figure c figure d figure e - make sure you use the correct dosing dispenser size for your prescribed dose (see table 1). - after 100 days, replace with a new dosing dispenser provided. a new replacement dosing dispenser may be used within the 100 days if necessary. - check the dosing dispenser for any damage to the barrel, plunger or tip (see figure g). if you cannot see the dosage marking or if it becomes hard to move the plunger, replace with a new dosing dispenser. figure f figure g figure h figure i figure j figure k figure l figure m figure n figure o figure p figure q figure r section c: cleaning instructions for the dosing dispenser figure s figure t figure u figure v figure w figure x before you give the next dose, put the dosing dispenser back together by pushing the plunger into the barrel (see figure y). figure y section d: disposal - throw away (dispose of) the bottle of livmarli following the steps below 100 days after first opened or after the throw away (discard) date listed on the pharmacy label, even if there is still medicine in it. mix medicine with a substance such as dirt, cat litter, or used coffee grounds. place the mixture in a container such as a sealed plastic bag. delete all personal information on the prescription label of the empty medicine bottle, then throw away (dispose of) in the household trash or recycle the empty bottle. - mix medicine with a substance such as dirt, cat litter, or used coffee grounds. - place the mixture in a container such as a sealed plastic bag. - delete all personal information on the prescription label of the empty medicine bottle, then throw away (dispose of) in the household trash or recycle the empty bottle. - throw away (dispose of) used dosing dispensers in the household trash.

Canada - anglais - Health Canada

mirum pharmaceuticals, inc. - maralixibat (maralixibat chloride) - solution - 9.5mg - maralixibat (maralixibat chloride) 9.5mg

Israël - anglais - Ministry of Health

neopharm (israel) 1996 ltd - maralixibat chloride - solution (oral) - maralixibat chloride 10 mg/ml - maralixibat chloride - livamrli ® is an ileal bile acid transporter (ibat) inhibitor indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 1 year of age and older.

Union européenne - anglais - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

États-Unis - anglais - NLM (National Library of Medicine)

maia pharmaceuticals, inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of a hypersensitivity reaction to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)]. - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide for inj

États-Unis - anglais - 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

États-Unis - anglais - NLM (National Library of Medicine)

hospira, inc. - zinc chloride (unii: 86q357l16b) (zinc cation - unii:13s1s8sf37) - zinc cation 1 mg in 1 ml - zinc 1 mg/ml (zinc chloride injection, usp) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition. administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms. none known.

États-Unis - anglais - NLM (National Library of Medicine)

american regent, inc. - zinc sulfate anhydrous (unii: 0j6z13x3wo) (zinc cation - unii:13s1s8sf37) - zinc cation 1 mg in 1 ml - zinc sulfate injection, usp is indicated for use as a supplement to intravenous solutions given for tpn. administration helps to maintain plasma levels and to prevent depletion of endogenous stores. zinc sulfate injection, usp should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential to increase renal loss of zinc from a bolus injection.

Union européenne - anglais - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, non-small-cell lung - antineoplastic agents - tremelimumab astrazeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

États-Unis - anglais - 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