Neutrexin Side Effects
Generic Name: trimetrexate
Note: This document contains side effect information about trimetrexate. Some of the dosage forms listed on this page may not apply to the brand name Neutrexin.
Applies to trimetrexate: intravenous powder for injection
Because many patients in clinical trials had advanced HIV disease, it was difficult to distinguish between trimetrexate-associated side effects and underlying medical conditions. In a clinical trial, 10% of patients in the trimetrexate-leucovorin group discontinued treatment due to side effects, as compared to 29% in the sulfamethoxazole-trimethoprim group.[Ref]
Hematologic toxicity has been the primary dose-limiting adverse effect. In a clinical trial (n=109) trimetrexate (the active ingredient contained in Neutrexin) commonly caused myelosuppression, resulting in neutropenia (<= 1000/mm3) in 30%, thrombocytopenia (<=75,000/mm3) in 10%, and anemia (Hgb<8 g/dL) in 7% of patients also treated with leucovorin. Therapy was discontinued in 3.7% of patients due to hematologic toxicity.[Ref]
Renal toxicity consisting of elevations in serum creatinine greater than 3 times upper normal limits has occurred in 0.9% of clinical trial patients treated with trimetrexate (the active ingredient contained in Neutrexin) and leucovorin.[Ref]
Gastrointestinal side effects associated with trimetrexate (the active ingredient contained in Neutrexin) have included nausea and vomiting in 5% or more of patients also treated with leucovorin. Mucositis and diarrhea also occur relatively often.[Ref]
Hepatic side effects have included transient elevations in liver function tests in up to 14% (n=109) of trial patients who also received leucovorin with increases greater than 5 times upper normal limits in AST (13.8%), ALT (11%), alkaline phosphatase (4.6%), and 2.5 times upper normal limit increases in bilirubin (1.8%). Discontinuation of therapy was necessary in approximately 3% of cases.[Ref]
Hypersensitivity reactions to trimetrexate (the active ingredient contained in Neutrexin) have occurred and are generally limited to skin rash and pruritus. However, severe reactions consisting of bronchospasm, hypotension, rigors, and fever have occurred rarely.[Ref]
Nervous system side effects have included confusion (2.8%) and fatigue (1.8%).[Ref]
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8. Fossella FV, Winn RJ, Holoye PY, Hallinan B, Raber MN, Hoelzer K, Young JA, Readling J, Bowers B, Hong WK "Phase II trial of trimetrexate for unresectable or metastatic non- small cell bronchogenic carcinoma." Invest New Drugs 10 (1992): 331-5
9. Allegra CJ, Chabner BA, Tuazon CU, et al. "Trimetrexate for the treatment of Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome." N Engl J Med 317 (1987): 978-85
10. Grem JL, King SA, Costanza ME, Brown TD "Hypersensitivity reactions to trimetrexate." Invest New Drugs 8 (1990): 211-4
11. King SA, Grem JL "Acute allergic reactions to trimetrexate (TMTX) (meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 7 (1988): a284
Some side effects may not be reported. You may report them to the FDA.