Neutrexin Side Effects

Generic name: trimetrexate

Note: This document contains side effect information about trimetrexate. Some dosage forms listed on this page may not apply to the brand name Neutrexin.

Applies to trimetrexate: intravenous powder for solution.

Serious side effects of Neutrexin

Along with its needed effects, trimetrexate (the active ingredient contained in Neutrexin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking trimetrexate:

More common

• Abdominal pain or tenderness
• black, tarry stools
• blood in urine or stools
• clay-colored stools
• dark urine
• decreased appetite
• fever and sore throat
• headache
• itching
• loss of appetite
• nausea and vomiting
• pinpoint red spots on skin
• skin rash
• swelling of feet or lower legs
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Less common

• Abdominal cramps
• coma
• confusion
• convulsions
• decreased urine output
• difficulty in breathing
• dizziness
• fast or irregular heartbeat
• hypocalcemia
• increased thirst
• mood or mental changes
• muscle cramps in hands, arms, feet, legs, or face
• muscle pain
• mouth sores or ulcers
• numbness and tingling around the mouth, fingertips, or feet
• skin rash and itching
• shortness of breath
• tremor

Rare

• Cough
• difficulty swallowing
• fainting or loss of consciousness
• fast or irregular breathing
• hives
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• swelling of eyes or eyelids
• tightness in chest
• trouble in breathing
• wheezing

Other side effects of Neutrexin

Some side effects of trimetrexate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Fatigue
• stomach pain

For Healthcare Professionals

Applies to trimetrexate: intravenous powder for injection.

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.^[Ref]

Hematologic

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

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

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

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

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]

Respiratory

Respiratory side effects have included dyspnea and rare cases of pneumonitis.^[Ref]

Metabolic

Metabolic abnormalities have included hyponatremia (4.6%) and hypocalcemia (1.8%).^[Ref]

Dermatologic

Dermatologic side effects have included alopecia in a few patients treated with trimetrexate (the active ingredient contained in Neutrexin) ^[Ref]

Nervous system

Nervous system side effects have included confusion (2.8%) and fatigue (1.8%).^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer