Generic Levoleucovorin Launched by Sandoz

Sandoz has introduced its ready-to-use levoleucovorin injection, a generic version of Spectrum Pharmaceuticals’ Fusilev, to the US market.

Marketed in a single-use vial, levoleucovorin is indicated for rescue use after high-dose methotrexate therapy in bone cancer, in addition to diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

“Sandoz is pleased to expand our high-quality portfolio of oncology injectables with this product launch,” said company president Peter Goldschmidt in a press release. “Generics, which offer the same quality and efficacy as branded pharmaceuticals, play an important role in increasing access while providing significant cost savings to payers, patients, and health care systems.”

According to the drug’s label, levoleucovorin may counteract the antiepileptic effect of phenobarbital, phenytoin, and primidone, as well as increase the frequency of seizures in susceptible patients. Vomiting, stomatitis, and nausea have been reported in patients receiving levoleucovorin as rescue after high-dose methotrexate treatment.

Levoleucovorin is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.

US sales for levoleucovorin were approximately $185 million for the 12 months ending in February 2015, according to IMS Health.