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alvogen inc. - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate tablets are indicated for the: methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pjia). methotrexate tablets are indicated for the treatment of adults with severe psoriasis. methotrexate tablets are contraindicated in: - pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see warnings and precautions (5.1), and use in specific populations (8.1, 8.3)] . - patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see warnings and precautions (5.2)] . risk summary methotrexate tablets are contraindicated in pregnant women with non-neoplastic diseases [see contraindications (4)]. based on published reports and its mechanism of action [see clinical pharmacology (12.1)] , methotrexate can cause embryo-fetal toxicity and fetal death when administered to a preg

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

antares pharma, inc. - methotrexate (unii: yl5fz2y5u1) (methotrexate - unii:yl5fz2y5u1) - methotrexate 7.5 mg in 0.4 ml - otrexup is indicated in the management of selected adults with severe, active rheumatoid arthritis (ra) (acr criteria), or children with active polyarticular juvenile idiopathic arthritis (pjia), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (nsaids). otrexup is indicated in adults for the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. it is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses. otrexup is not indicated for the treatment of neoplastic diseases. otrexup is contraindicated in the following: • pregnancy otrexup can cause embryo-fetal toxicity and fetal death when administered during pregnancy  [see warnings and precautions (5.2) and use in specific populations (8.1)]. • alcoholism or liver disease patients with alcoholism, alcoholic liver disease or other chronic liver disease [see warnings and precautions (5.1) ]. • immunodeficiency syndromes patients who have overt or laboratory evidence of immunodeficiency syndromes [see warnings and precautions (5.1) ]. • preexisting blood dyscrasias patients who have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia [see warnings and precautions (5.1)]. • hypersensitivity patients with a known hypersensitivity to methotrexate. severe hypersensitivity reactions have been observed with methotrexate use [see warnings and precautions (5.1) and adverse reactions (6.1 and 6.2)]. risk summary based on published reports and methotrexate’s mechanism of action, methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman [see data and clinical pharmacology (12.1)] . in pregnant women with non-malignant disease, otrexup is contraindicated. consider the benefits and risks of otrexup and risks to the fetus when prescribing otrexup to a pregnant patient. there are no animal data that meet current standards for nonclinical developmental toxicity studies. the estimated background risk of major birth defects and miscarriage for the indicated populations are 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. data human data published data from cases, literature reviews, and observational studies report that methotrexate exposure during pregnancy is associated with an increased risk of embryo-fetal toxicity and fetal death. methotrexate exposure during the first trimester of pregnancy is associated with an increased incidence of spontaneous abortions and multiple adverse developmental outcomes, including skull anomalies, facial dysmorphism, central nervous system abnormalities, limb abnormalities, and sometimes cardiac anomalies and intellectual impairment. adverse outcomes associated with exposure during second and third trimesters of pregnancy include intrauterine growth restriction and functional abnormalities. because methotrexate is widely distributed and persists in the body for a prolonged period, there is a potential risk to the fetus from preconception methotrexate exposure. a prospective multicenter study evaluated pregnancy outcomes in women taking methotrexate less than or equal to 30 mg/week after conception. the rate of miscarriage in pregnant women exposed to methotrexate was 42.5% (95% confidence interval [95% ci] 29.2-58.7), which was higher than in unexposed patients with autoimmune disease (22.5%, 95% ci 16.8-29.7) and unexposed patients with non-autoimmune disease (17.3%, 95% ci 13-22.8). of the live births, the rate of major birth defects in pregnant women exposed to methotrexate after conception was higher than in unexposed patients with autoimmune disease (adjusted odds ratio (or) 1.8 [95% ci 0.6-5.7]) and unexposed patients with non-autoimmune disease (adjusted or 3.1 [95% ci 1.03-9.5]). major birth defects associated with pregnancies exposed to methotrexate after conception were not always consistent with methotrexate-associated adverse developmental outcomes. risk summary limited published literature report the presence of methotrexate in human milk in low amounts following oral methotrexate administration, with the highest breast milk to plasma concentration ratio reported to be 0.08:1. no information is available on the effects of methotrexate on a breastfed infant or on milk production. because of the potential for serious adverse reactions including myelosuppression, from methotrexate in breastfed infants, advise women not to breastfeed during treatment with otrexup and for one week after the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating otrexup. contraception females otrexup can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during and for 6 months after the final dose of otrexup. males methotrexate can cause chromosomal damage to sperm cells. advise males with female partners of reproductive potential to use effective contraception during and for at least 3 months after the final dose of otrexup. infertility females based on published reports of female infertility after treatment with methotrexate, advise females of reproductive potential that otrexup can cause impairment of fertility and menstrual dysfunction during and after cessation of therapy. it is not known if the infertility may be reversed in all affected females. males based on published reports of male infertility after treatment with methotrexate, advise males of reproductive potential that otrexup can cause oligospermia or infertility during and after cessation of therapy. it is not known if the infertility may be reversed in all affected males. the safety and effectiveness of methotrexate, including otrexup, have not been established in pediatric patients with psoriasis. the safety and effectiveness of otrexup have not been established in pediatric patients with neoplastic diseases. the safety and effectiveness of methotrexate have been established in pediatric patients with polyarticular juvenile idiopathic arthritis [see clinical studies (14.2)] . published clinical studies evaluating the use of methotrexate in children and adolescents (i.e., patients 2 to 16 years of age) with pjia demonstrated safety comparable to that observed in adults with rheumatoid arthritis [see adverse reactions (6.1) ]. otrexup does not contain a preservative. however, methotrexate injectable formulations containing the preservative benzyl alcohol are not recommended for use in neonates. there have been reports of fatal ‘gasping syndrome’ in neonates (children less than one month of age) following the administrations of intravenous solutions containing the preservative benzyl alcohol. symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse. serious neurotoxicity, frequently manifested as generalized or focal seizures, has been reported with unexpectedly increased frequency among pediatric patients with acute lymphoblastic leukemia who were treated with intermediate-dose intravenous methotrexate (1 gm/m2 ) [see warnings and precautions (5.1)] . clinical studies of methotrexate did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic and renal function, decreased folate stores, concomitant disease or other drug therapy (i.e., that interfere with renal function, methotrexate or folate metabolism) in this population [see warnings and precautions (5.1), drug interactions (7.7) and use in specific populations (8.6)]. since decline in renal function may be associated with increases in adverse reactions and serum creatinine measurements may over estimate renal function in the elderly, more accurate methods (i.e., creatinine clearance) should be considered. serum methotrexate levels may also be helpful. elderly patients should be closely monitored for early signs of hepatic, bone marrow and renal toxicity. in chronic use situations, certain toxicities may be reduced by folate supplementation. post-marketing experience suggests that the occurrence of bone marrow suppression, thrombocytopenia, and pneumonitis may increase with age [see warnings and precautions (5.1)]. methotrexate elimination is reduced in patients with impaired renal function. such patients require especially careful monitoring for toxicity and require dose reduction or, in some cases, discontinuation of otrexup administration. the effect of hepatic impairment on methotrexate pharmacokinetics has not been studied. otrexup is contraindicated in patients with alcoholic liver disease or other chronic liver disease. patients with obesity, diabetes, hepatic fibrosis or steatohepatitis are at increased risk for hepatic injury and fibrosis secondary to methotrexate, and should be monitored closely [see warnings and precautions (5.1)] . read this instructions for use before using otrexup™ (oh-treks-up) (methotrexate) injection, for subcutaneous use prepare to use otrexup - do not remove cap (marked 1) or safety clip (marked 2) until you are ready to inject otrexup. - wash your hands well with soap and warm water. - check the expiration date on the label. do not use if expired. - check the seal. do not use otrexup if the seal is broken (see figure b ). - in addition to otrexup, you will need the following items: 1 alcohol swab and 1 cotton ball or gauze. check the liquid - look at the viewing window (see figure c ). - the liquid should be yellow in color and should not have any lumps or particles in it. - you may see an air bubble. this is normal. choose an injection site - otrexup should be injected into the stomach (abdomen) or thigh. do not inject otrexup within 2 inches of the belly button (navel) (see figure d ). - do not inject otrexup in the arms or any other areas of the body. - do not inject otrexup in areas where the skin is tender, bruised, red, scaly, hard, or has scars or stretch marks. - wipe the area with an alcohol swab. - allow the skin to dry and do not touch this area again before giving otrexup. do not fan or blow on the clean area. give your injection step 1: remove cap (marked 1) - twist cap marked 1 to remove (see figure e ). this will break the seal. - you may notice 1 or 2 drops of medicine. this is normal. - do not touch the needle end with your hands or fingers. this could inject the medicine into your hand. - do not replace the cap after it has been removed. - after the cap is removed otrexup must be used or disposed of safely (see step 5). step 2: remove the safety clip (marked 2) - flip the safety clip marked 2 (see figure f ). step 3: inject otrexup - place needle end of otrexup flat against thigh or stomach (abdomen) at a 90° and firmly push device against the injection site until fully depressed. you will hear a click, hold for 3 seconds (slowly count 1,2,3) (see figure g ). - after counting to 3, remove otrexup from the injection site. you may notice a small amount of blood or liquid at the administration site, which is normal. - press a cotton ball or gauze on the area for 10 seconds. do not rub the area. step 4: check the viewing window - check the viewing window (see figure h ). - the viewing window will be half blocked with a red flag to show that the full dose was delivered. (see figure h ). - dispose of otrexup in a puncture-proof disposable container (see step 5) . - if the viewing window is not half blocked with a red flag , call your doctor or pharmacist, or call 1-855-otrexup (1-855-687-3987) for help. - do not use another otrexup without talking to your doctor. step 5: dispose of otrexup - do not throw away in the household trash . put used otrexup in a fda-cleared sharps disposal container right away after use. - 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 properly labeled to warn of hazardous waste inside the container - 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 - 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 the 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. - safely dispose of otrexup that is out of date or no longer needed. how should i store otrexup? - store otrexup at room temperature between 68°f to 77°f (20°c to 25°c). do not freeze. - keep otrexup out of the light. this instructions for use has been approved by the u.s. food and drug administration. mfd. for antares pharma, inc. ewing, nj 08628 12/2019 pii-13-001 v11

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