FUSILEV® Logo

Important Safety Information  |  Full Prescribing Information
  • Text Size  A | A | A

    • FAQ

    Frequently Asked Questions

    What is FUSILEV?

    Why is folinic acid included with 5-FU in mCRC treatment?

    Is FUSILEV the same as leucovorin?

    How long have there been shortage issues with leucovorin supply?

    Is the dose of FUSILEV the same as conventional leucovorin?

    What important safety information about FUSILEV should I know?

    Where can I order FUSILEV?

    What is the J-code for FUSILEV?

    Are there any programs to help provide financial support to my patients?

    What is FUSILEV?

    FUSILEV (levoleucovorin) for injection is a folate analog. FUSILEV is the pharmacologically active isomer of leucovorin. In mCRC treatment, FUSILEV works to enhance the therapeutic and toxic effects of 5-fluorouracil.1 Learn more about FUSILEV in mCRC treatment >

    Why is folinic acid included with 5-FU in mCRC treatment?

    Folinic acid has been shown to enhance the therapeutic and toxic effects of 5-FU. The biological rationale for adding folinic acid into 5-FU treatment derives from the mechanism of action of 5-FU and folinic acid in blocking cell growth.2,3

    Is FUSILEV the same as leucovorin?

    No. FUSILEV is levoleucovorin, the levo isomeric form of racemic d,l-leucovorin.1 While conventional leucovorin is a racemic mixture of the d- and l-isomers of folinic acid, FUSILEV contains nearly pure pharmacologically active l-isomer. Learn more >

    Because FUSILEV is the pharmacologically active isomer of leucovorin, it is dosed at one-half the usual dose of d,l-leucovorin.1 There is potential for dosing errors when interchanging leucovorin and levoleucovorin. Learn more about dosing FUSILEV >

    How long have there been shortage issues with leucovorin supply?

    Leucovorin supply issues have not been resolved for over 48 months—since December 2008.4 Learn more about leucovorin supply issues >

    Is the dose of FUSILEV the same as conventional leucovorin?

    Because FUSILEV is the pharmacologically active isomer of leucovorin, it is dosed at one-half the usual dose of d,l-leucovorin.1 There is potential for dosing errors when interchanging leucovorin and levoleucovorin. Learn more about dosing FUSILEV >

    What important safety information about FUSILEV should I know?

    View safety information for FUSILEV >

    Where can I order FUSILEV?

    FUSILEV is readily available – you can order it today through major distributors or by calling 1-877-FUSILEV (1-877-387-4538).

    View detailed ordering information for practices >

    View detailed ordering information for hospitals >

    What is the J-code for FUSILEV?

    FUSILEV has a unique J-code for reimbursement – J0641 per 0.5 mg unit of FUSILEV.

    Are there any programs to help provide financial support to my patients?

    Spectrum is committed to helping you and your patients access FUSILEV. That’s why we created the Spectrum Therapy Access Resources (STAR®) Program. The STAR Program provides assistance with benefit verification, obtaining prior authorizations, appeals assistance, and financial assistance for uninsured or underinsured patients.

    Learn more about the STAR program >

    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.

    References:
    1. FUSILEV [package insert]. Irvine, CA: Spectrum Pharmaceuticals, Inc.
    2. Peters GJ, Van Der Wilt CL, Van Triest B, et al. Thymidylate synthase and drug resistance. Eur J Cancer. 1995;31A(7/8):1299-1305.
    3. Santi DV, McHenry CS, Sommer H. Mechanism of interaction of thymidylate synthetase with5-fluorodeoxyuridylate.Biochemistry.1974;13(1):471-480.
    4. U.S. Food and Drug Administration (FDA). FDA current drug shortages. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314741.htm#leucovorin. Updated December 17, 2012. Accessed December 20, 2012.