Spectrum expanded FUSILEV manufacturing capacity in 2012 to continue to meet 100% of market demand.
FUSILEV is readily available today
Inconsistent supply of d,l-leucovorin continues
- Leucovorin supply issues have not been fully resolved in over 48 months—since December 20081
- Several leucovorin manufacturers continue to report suspended manufacturing, delays, and inability to produce to demand2
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FUSILEV is readily available with consistent supply
FUSILEV is available through major distributors
1. 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.
2. American Society of Health-System Pharmacists (ASHP). Current drug shortage bulletin: Leucovorin calcium injection. https://www.ashp.org/DrugShortages/Current/bulletin.aspx?id=488. Updated December 18, 2012. Accessed December 20, 2012.
3. AHA survey on drug shortages. American Hospital Association Web site. http://www.aha.org/research/index.shtml. Published July 12, 2011. Accessed December 20, 2012.
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
- 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.
- 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.
- 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.