Otrexup

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Psoriasis

Otrexup Generic Name & Formulations

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

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

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

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