Trimetrexate Side Effects

Brand Names: Neutrexin

Please note - some side effects for Trimetrexate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Trimetrexate - for the Consumer

Trimetrexate

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trimetrexate:

Confusion; fatigue.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; drops in counts of blood cells; fever; itching; nausea; sores in mouth; symptoms of a new infection; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellow discoloration of skin or eyes.

Side Effects by Body System

General

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.

Hematologic

Hematologic toxicity has been the primary dose-limiting adverse effect. In a clinical trial (n=109) trimetrexate 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.

Renal

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 and leucovorin.

Gastrointestinal

Gastrointestinal side effects associated with trimetrexate have included nausea and vomiting in 5% or more of patients also treated with leucovorin. Mucositis and diarrhea also occur relatively often.

Hepatic

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.

Hypersensitivity

Hypersensitivity reactions to trimetrexate have occurred and are generally limited to skin rash and pruritus. However, severe reactions consisting of bronchospasm, hypotension, rigors, and fever have occurred rarely.

Respiratory

Respiratory side effects have included dyspnea and rare cases of pneumonitis.

Metabolic

Metabolic abnormalities have included hyponatremia (4.6%) and hypocalcemia (1.8%).

Dermatologic

Dermatologic side effects have included alopecia in a few patients treated with trimetrexate.

Nervous system

Nervous system side effects have included confusion (2.8%) and fatigue (1.8%).

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