Generic Name and Formulations:
Methotrexate (MTX) 10mg/0.4mL, 15mg/0.4mL, 20mg/0.4mL, 25mg/0.4mL; soln for SC inj; preservative-free.

Company:
Antares Pharma

 

Indications for OTREXUP:

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. Limitation of use: not for treating neoplastic diseases.

Adult Dose for OTREXUP:

Administer by SC inj in abdomen or thigh. Initially 7.5mg once weekly using an oral formulation. Switching from oral to Otrexup SC inj: consider differences in bioavailability. Adjust dose gradually. 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's Dose for OTREXUP:

<2yrs: not established. Administer by SC inj in abdomen or thigh. ≥2yrs: initially 10mg/m² once weekly. Switching from oral to Otrexup SC inj: consider differences in bioavailability. Adjust dose gradually. 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.

Pharmacological Class:

Folic acid antagonist.

Contraindications:

Alcoholism. Chronic liver disease. Immunodeficiency. Preexisting blood dyscrasias. Pregnancy (Cat.X). Nursing mothers.

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. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Hepatic fibrosis. Steatohepatitis. Active infection. Renal impairment, ascites, pleural effusions: monitor for toxicity and reduce dose or discontinue if needed. Maintain adequate hydration. Elderly. Debilitated.

Interactions:

Avoid live virus vaccines. Toxicity increased by NSAIDs, salicylates, low-dose steroids, PPIs (eg, omeprazole, esomeprazole, pantoprazole), phenylbutazone, phenytoin, sulfonamides, probenecid, penicillins (monitor), tetracycline, chloramphenicol, non-absorbable broad spectrum antibiotics, folic acid antagonists. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine); monitor. Impaired response to immunization. May potentiate theophylline, mercaptopurine. May be antagonized by folic acid. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Recall reactions after UV radiation.

Adverse Reactions:

Nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leucopenia, pancytopenia, dizziness, photosensitivity, and “burning of skin lesions”; myelosuppression, hepatotoxicity, nephrotoxicity, CNS toxicity, interstitial pneumonitis, tumor lysis syndrome, fatal skin reactions, fertility impairment.

How Supplied:

Single-dose auto-injector—1, 4