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Important Safety Information  |  Full Prescribing Information
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    Indications and Usage

    FUSILEV is a folate analog indicated for:

    • Rescue after high-dose methotrexate therapy in osteosarcoma.
    • Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
    • Use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

    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.
    • The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving FUSILEV in combination with 5-FU were diarrhea, nausea and stomatitis.
    • 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.

    Please click here to see full Prescribing Information for FUSILEV.