About Fusilev What is Fusilev How is Fusilev different? What do folates do? Colorectal Cancer What is colorectal cancer? Other Indications What is osteosarcoma? How is osteosarcoma treated? What is methotrexate rescue? How is Fusilev used in mtx rescue? How is Fusilev used in delayed mtx elimination? How is Fusilev used in mtx rescue in osteosarcoma? Folic Acid Antagonists What is a folic acid antagonist? Provider Resources Prescribing Information Dosing Information Reimbursement Services Contact a Representative

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.
Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy.
The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving Fusilev in combination with 5-FU were diarrhea, nausea and stomatitis.

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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