Monograph Details
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Neoplasms
> Antimetabolites
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TREXALL |
| Manufacturer |
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Duramed Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Folic acid antagonist. |
| Generic Name |
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Methotrexate sodium 5mg, 7.5mg, 10mg, 15mg; scored tabs. |
| Also |
• Methotrexate for injection
• Methotrexate injection
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| Indications |
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Gestational choriocarcinoma. Chorioadenoma destruens. Hydatidiform mole. Breast cancer. Epidermoid cancers of the head and neck. Advanced mycosis fungoides (cutaneous T-cell lymphoma). Lung cancer (squamous cell and small cell types). Advanced stage non-Hodgkin's lymphomas. |
| Children |
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See literature. |
| Adults |
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See literature. Tablet form is often preferred when low doses are being administered. Choriocarcinoma and similar trophoblastic diseases: 15–30mg orally or by IM inj daily for 5 days; usually repeated 3–5 times as required with a rest period of ≥1 week between courses. Leukemia: Induction: 3.3mg/m2 + prednisone, given daily; maintenance: give twice weekly either orally or by IM inj for a total weekly dose of 30mg/m2; or 2.5mg/kg IV every 14 days. Meningeal leukemia (treatment): 12mg/m2 intrathecally (max 15mg) at intervals of 2–5 days; see literature for prophylaxis treatment. Burkitt's tumor (stage I–II): 10–25mg per day orally for 4–8 days. Lymphosarcomas (stage III): 0.625–2.5mg/kg daily. Mycosis fungoides (cutaneous T cell lymphoma): 5–50mg once weekly. Osteosarcoma: initially 12g/m2 IV infusion over 4 hours; may be increased to 15g/m2; see literature for leucovorin rescue dosing with high-dose methotrexate. |
| Contraindications |
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Pregnancy (Cat. X). Nursing mothers. |
| Precautions |
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Be fully familiar with this drug's toxicity before use. 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. 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. Hepatic or renal impairment. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Infection. Dehydration. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Elderly (use low doses and monitor closely). Debilitated. |
| Interactions |
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Avoid live virus vaccines. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, chloramphenicol, non-absorbable broad spectrum antibiotics. May be antagonized by folic acid. May potentiate theophylline, mercaptopurine. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin). |
| Adverse Reactions |
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Ulcerative stomatitis, leukopenia, nausea, GI upset, malaise, fatigue, chills, fever, dizziness, infection, myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, seizures (esp in children); interstitial pneumonitis, tumor lysis syndrome, skin reactions (may be fatal; eg, toxic epidermal necrolysis, Stevens-Johnson syndrome). |
| How Supplied |
Tabs—30
Soln (2mL, 4mL, 8mL, 10mL)—10 (single-use vials)
Pwd (1 gram)—1 (single-use vial) |
| Additional Resources |
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• Related Prescribing Note |
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