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FDA approves glucarpidase to treat patients with toxic methotrexate levels
The FDA has approved glucarpidase to aid patients with toxic blood levels of methotrexate caused by kidney failure.
Although methotrexate is a common chemotherapy drug, patients receiving high doses may develop kidney failure over time. Glucarpidase (Voraxaze, BTG International), once administered intravenously, rapidly reduces methotrexate levels by breaking the chemotherapy drug down to a form that can be eliminated from the body.
“Prolonged exposure to high levels of methotrexate can result in kidney and liver damage, severe mouth sores, damage to the lining of the intestine, skin rashes, and death due to low blood counts,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research, said in a press release. “Voraxaze is an important new treatment option for cancer patients aimed at preventing these toxicities associated with sustained high levels of methotrexate.”
The efficacy of glucarpidase for this indication is based on the results of a single clinical study of 22 patients in which all patients received glucarpidase treatment. The goal of the study was the reduction of methotrexate below a critical level within 15 minutes and to maintain that status for a minimum of 8 days — 10 of the 22 patients achieved this standard. Although the results were not uniform among the study participants, glucarpidase was observed to eliminate 95% of the methotrexate in all patients.
A separate clinical study evaluated the safety of glucarpidase in 290 patients experiencing problems clearing methotrexate from their blood. Adverse effects observed in more than 1% of patients in the study were hypotension, headache, nausea, vomiting, flushing and paraesthesia.
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