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Levoleucovorin, a Folate Analog, Gets FDA Approval for Injection
The FDA has approved Levoleucovorin (Khapzory, Spectrum Pharmaceuticals, Henderson, Nevada) for injection for three indications:
- rescue after high-dose methotrexate therapy in patients with osteosarcoma;
- diminishing toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination; and
- treatment for metastatic colorectal cancer in combination with fluorouracil.
Levoleucovorin is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 as there is a risk of neurologic manifestations progressing, despite hematologic remission. Patients who have experienced severe hypersensitivity to leucovorin products, folic acid, or folinic acid should not use levoleucovorin.
Common adverse reactions in patients who received levoleucovorin rescue with high-dose methotrexate therapy included stomatitis (38%) and vomiting (38%). The most common adverse reactions in patients treated with levoleucovorin in combination with fluorouracil for metastatic colorectal cancer included stomatitis (72%), diarrhea (70%), and nausea (62%).
Spectrum expects to launch the drug in January 2019.
Source: Healio.com, October 23, 2018