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INDICATIONS AND USAGE
• FUSILEV is a folate analog.
• FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma.
• FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of
inadvertent overdosage of folic acid antagonists.
LIMITATIONS OF USE
FUSILEV is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.
IMPORTANT SAFETY INFORMATION
Contraindications
• FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.
Warnings and Precautions
• Due to Ca++ content, no more than 16 mL (160 mg) of levoleucovorin solution should be injected intravenously per minute
• FUSILEV enhances the toxicity of fluorouracil.
• Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in HIV patients
was associated with increased rates of treatment failure in a placebo-controlled study.
Adverse Reactions
Allergic reactions were reported in patients receiving FUSILEV.
Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients
receiving FUSILEV as rescue after high dose methotrexate therapy.
Drug Interactions
FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin
and primidone, and increase the frequency of seizures in susceptible patients.
Reporting of Suspected Adverse Reactions
You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the FUSILEV (levoleucovorin) for injection full prescribing information for complete safety information.
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