Spectrum PH宣布，向美国FDA提交新药上市申请补件(sNDA)，有关 即用配方的FUSILEV (levoleucovorin)注射剂，支持FUSILEV用於治疗大肠癌. 

FDA accepts sNDA for colorectal cancer indication for Fusilev
Spectrum Pharmaceuticals announced that it received notification that the FDA has accepted for filing and review the supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) for injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. Fusilev is the pharmacologically active isomer of leucovorin and is available as a freeze-dried powder for IV injection after reconstitution. 

Fusilev is already indicated for use in osteosarcoma, to reduce toxicity of high-dose methotrexate (MTX) therapy and to reduce toxicity and counteract effects of impaired MTX elimination and of inadvertent overdose of folic acid antagonists.

INDICATIONS AND USAGE

• FUSILEV is a folate analog.
• FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma.
• FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of
   inadvertent overdosage of folic acid antagonists.

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.

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  or call 1-800-FDA-1088.