You are here

Levoleucovorin, a Folate Analog, Gets FDA Approval for Injection

Prevents Harmful Effects of Chemotherapy

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

Recent Headlines

Findings from ISCHEMIA trial may mean fewer stents and bypass operations for those with stable disease
Donors hope to vaccinate 450 million children each year
New Novartis drug cuts rate of crises by 45% relative to placebo
FDA says new Pentax design is easier to clean
Myovant’s drug would offer a new oral, once-daily treatment option
More research is needed to confirm the finding
Study shows "complex genetic risk architecture"
Study says yes, interventions cuts need for meds
Review of 18 studies finds that medium doses have the strongest effects