New Formulation of Levoleucovorin Approved

June 2011, Vol 2, No 3 - FDA Approvals, News & Updates


A new, ready-to-use (RTU) injectable formulation of the folate analog levoleucovorin (Fusilev; Spectrum Pharmaceuticals) received FDA approval. Like the previously approved lyophilized formulation, the RTU formulation is indicated for rescue after high-dose methotrexate therapy in the treatment of osteosarcoma.

Levoleucovorin is also indicated for reducing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

Levoleucovorin is available in vials as freeze-dried powder and in singleuse vials containing 17.5-mL and 25-mL sterile solution. When administered as rescue therapy, the recommended dosage is 7.5 mg every 6 hours for 10 doses. (April 29, 2001)