Otrexup Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate (MTX) 10mg/0.4mL, 15mg/0.6mL, 17.5mg/0.7mL, 20mg/0.8mL, 22.5mg/0.9mL, 25mg/mL; soln for SC inj; preservative-free.
Pharmacological Class
Folic acid antagonist.
How Supplied
Single-dose auto-injector—4
Manufacturer
Otrexup Indications
Indications
Management of adults with severe, active rheumatoid arthritis (RA) 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 NSAIDs.
Limitations of Use
Not for treating neoplastic diseases.
Otrexup Dosage and Administration
Adult
Administer by SC inj in abdomen or thigh. Initially 7.5mg once weekly; adjust dose gradually. Switching from oral to Otrexup SC inj: consider differences in bioavailability. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <10mg/wk or >25mg/wk, high-dose regimens, or dose adjustments <5mg increments.
Children
<2yrs: not established. Administer by SC inj in abdomen or thigh. ≥2yrs: initially 10mg/m2 once weekly; adjust dose gradually. Switching from oral to Otrexup SC inj: consider differences in bioavailability. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <10mg/wk or >25mg/wk, high-dose regimens, or dose adjustments <5mg increments.
Otrexup Contraindications
Contraindications
Alcoholism. Chronic liver disease. Immunodeficiency. Preexisting blood dyscrasias. Pregnancy.
Otrexup Boxed Warnings
Boxed Warning
Severe toxic reactions and death. Embryo-fetal toxicity.
Otrexup Warnings/Precautions
Warnings/Precautions
Be fully experienced in the use of antimetabolite therapy. Increased risk of severe toxic reactions. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function, every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Obtain liver biopsy prior to treatment if history of alcoholism, persistently abnormal LFTs, or chronic HBV/HCV infection; discontinue if persistently abnormal LFTs develop or liver biopsy shows moderate to severe changes. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Peptic ulcer. Ulcerative colitis. Active infection. Obesity. Diabetes. Hepatic fibrosis. Steatohepatitis. Renal impairment, ascites, pleural effusions: monitor for toxicity and reduce dose or discontinue if needed. Maintain adequate hydration. Elderly. Debilitated. Embryo-fetal toxicity. Exclude pregnancy status prior to initiation. Advise use of effective contraception during and for 6 months (females of reproductive potential) and for ≥3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).
Otrexup Pharmacokinetics
See Literature
Otrexup Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, low-dose steroids, PPIs (eg, omeprazole, esomeprazole, pantoprazole), phenylbutazone, phenytoin, sulfonamides, probenecid, penicillins (monitor), folic acid antagonists. May be antagonized by oral antibiotics (eg, tetracycline, chloramphenicol, non-absorbable broad spectrum antibiotics), folic acid. Increased hepatotoxicity with concomitant other hepatotoxins (eg, azathioprine, retinoids, sulfasalazine); monitor. Impaired response to immunization. May potentiate theophylline, mercaptopurine; monitor. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Recall reactions after UV radiation.
Otrexup Adverse Reactions
Adverse Reactions
Nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, rash, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leucopenia, pancytopenia, dizziness, photosensitivity, “burning of skin lesions”; myelosuppression, hepatotoxicity, nephrotoxicity, CNS toxicity, interstitial pneumonitis, tumor lysis syndrome, fatal skin reactions.
Otrexup Clinical Trials
See Literature
Otrexup Note
Not Applicable
Otrexup Patient Counseling
See Literature
Otrexup Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate (MTX) 10mg/0.4mL, 15mg/0.6mL, 17.5mg/0.7mL, 20mg/0.8mL, 22.5mg/0.9mL, 25mg/mL; soln for SC inj; preservative-free.
Pharmacological Class
Folic acid antagonist.
How Supplied
Single-dose auto-injector—4
Manufacturer
Otrexup Indications
Indications
Symptomatic control of severe, recalcitrant, disabling psoriasis in adults with inadequate response to other forms of therapy, but only with an established diagnosis as by biopsy and/or dermatologic consultation.
Limitations of Use
Not for treating neoplastic diseases.
Otrexup Dosage and Administration
Adult
Administer by SC inj in abdomen or thigh. 10–25mg once weekly using an oral, IM, SC, or IV formulation; max 30mg/wk. Adjust dose gradually. Switching from oral to Otrexup SC inj: consider differences in bioavailability. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <10mg/wk or >25mg/wk, high-dose regimens, or dose adjustments <5mg increments.
Children
Not established.
Otrexup Contraindications
Contraindications
Alcoholism. Chronic liver disease. Immunodeficiency. Preexisting blood dyscrasias. Pregnancy.
Otrexup Boxed Warnings
Boxed Warning
Severe toxic reactions and death. Embryo-fetal toxicity.
Otrexup Warnings/Precautions
Warnings/Precautions
Be fully experienced in the use of antimetabolite therapy. Increased risk of severe toxic reactions. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function, every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Obtain liver biopsy prior to treatment if history of alcoholism, persistently abnormal LFTs, or chronic HBV/HCV infection; discontinue if persistently abnormal LFTs develop or liver biopsy shows moderate to severe changes. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Peptic ulcer. Ulcerative colitis. Active infection. Obesity. Diabetes. Hepatic fibrosis. Steatohepatitis. Renal impairment, ascites, pleural effusions: monitor for toxicity and reduce dose or discontinue if needed. Maintain adequate hydration. Elderly. Debilitated. Embryo-fetal toxicity. Exclude pregnancy status prior to initiation. Advise use of effective contraception during and for 6 months (females of reproductive potential) and for ≥3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).
Otrexup Pharmacokinetics
See Literature
Otrexup Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, low-dose steroids, PPIs (eg, omeprazole, esomeprazole, pantoprazole), phenylbutazone, phenytoin, sulfonamides, probenecid, penicillins (monitor), folic acid antagonists. May be antagonized by oral antibiotics (eg, tetracycline, chloramphenicol, non-absorbable broad spectrum antibiotics), folic acid. Increased hepatotoxicity with concomitant other hepatotoxins (eg, azathioprine, retinoids, sulfasalazine); monitor. Impaired response to immunization. May potentiate theophylline, mercaptopurine; monitor. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Recall reactions after UV radiation.
Otrexup Adverse Reactions
Adverse Reactions
Nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, rash, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leucopenia, pancytopenia, dizziness, photosensitivity, “burning of skin lesions”; myelosuppression, hepatotoxicity, nephrotoxicity, CNS toxicity, interstitial pneumonitis, tumor lysis syndrome, fatal skin reactions.
Otrexup Clinical Trials
See Literature
Otrexup Note
Not Applicable
Otrexup Patient Counseling
See Literature