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What is osteosarcoma?
Osteosarcoma is a type of bone cancer. Bone cancer is a malignant (cancerous) tumor of the bone that destroys normal bone tissue. Osteosarcoma occurs most often in the long bones of the limbs. Less frequently, osteosarcoma can occur in any other bone.
How is osteosarcoma treated?
Osteosarcoma treatment is usually based on a combined approach of surgery and chemotherapy.
The 4 main chemotherapies are:
• High-dose methotrexate with rescue
• Doxorubicin
• Cisplantin
• Ifosfamide
If you believe that you or anyone you know, such as your child, may have bone cancer, ask a doctor to explain the characteristics of osteosarcoma and the choices of treatment.
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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