FUSILEV® Homepage
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What is FUSILEV?

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

Is FUSILEV the same as leucovorin?

What is levoleucovorin?

How long have there been shortage issues with leucovorin supply?

Is the dose of FUSILEV the same as generic racemic leucovorin?

What important safety information about FUSILEV should I know?

Where can I order FUSILEV?

What is the J-code for FUSILEV?

 
Spectrum is committed to helping you and your patients access FUSILEV.

Spectrum is committed to helping you and your patients access FUSILEV.

Learn about Spectrum’s reimbursement support

 

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 generic leucovorin is a racemic mixture of the d- and l-isomers of folinic acid, FUSILEV is the 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 generic racemic leuvovorin.1 There is potential for dosing errors when interchanging generic racemic leucovorin and levoleucovorin. Learn more about dosing FUSILEV >

What is levoleucovorin?

FUSILEV is levoleucovorin—the pharmacologically active isomer in modulation of 5-FU.1 Levoleucovorin is the only isomer that potentiates the activity of 5-FU in mCRC treatment. > 4

How long have there been shortage issues with leucovorin supply?

Leucovorin supply issues have not been fully resolved since December 2008.5 Learn more about leucovorin supply issues >

Is the dose of FUSILEV the same as generic racemic leucovorin?

FUSILEV is dosed at one-half the usual dose of generic racemic 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 available—you can order it today through major distributors or by calling 1-877-FUSILEV (1-877-387-4538).

View detailed ordering information for hospitals >

View detailed ordering information for practices >

What is the J-code for FUSILEV?

FUSILEV has an exclusive 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-FU 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. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly d,l-leucovorin and 5-fluorouracil. When these drugs are administered concurrently in the palliative treatment of advanced colorectal cancer, the dosage of 5-FU must be lower than usually administered. Although the toxicities observed in patients treated with the combination of FUSILEV and 5-FU are qualitatively similar to those observed with 5-FU alone, gastrointestinal toxicities (particularly stomatitis and diarrhea) are observed more commonly and may be of greater severity and of prolonged duration in patients treated with the combination.
  • 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.

FUSILEV adverse event profile

Adverse reactions (≥10% in either arm) in patients with advanced metastatic colorectal cancer

Adverse Reaction Levoleucovorin/5FU
n=318
d,l-Leucovorin/5FU
n=307
Adverse Event N (%) Grade 1–4 Grade 3–4 Grade 1–4 Grade 3–4
Gastrointestinal Disorders
Stomatitis 229 (72%) 37 (12%) 221 (72%) 44 (14%)
Diarrhea 222 (70%) 61 (19%) 201 (65%) 51 (17%)
Nausea 197 (62%) 25 (8%) 186 (61%) 26 (8%)
Vomiting 128 (40%) 17 (5%) 114 (37%) 18 (6%)
Abdominal Pain* 45 (14%) 10 (3%) 57 (19%) 10 (3%)
General Disorders
Asthenia/Fatigue/Malaise 91 (29%) 15 (5%) 99 (32%) 34 (11%)
Metabolism and Nutrition
Anorexia/Decreased Appetite 76 (24%) 13 (4%) 77 (25%) 5 (2%)
Skin Disorders
Dermatitis 91 (29%) 3 (1%) 86 (28%) 4 (1%)
Alopecia 83 (26%) 1 (0.3%) 87 (28%) 3 (1%)

* Includes abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal tenderness

ISI-0154-079600

Please click here to see full Prescribing Information for FUSILEV.

Reporting of Suspected Adverse Reactions

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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 with 5-fluorodeoxyuridylate. Biochemistry.1974;13(1):471-481.
4. Bleyer WA. New vistas for leucovorin in cancer chemotherapy. Cancer. 1989;63:995-1007.
5. U.S. Food and Drug Administration (FDA). FDA current drug shortages. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314741.htm#leucovorin. Updated May 9, 2013. Accessed May 21, 2013.

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