Annals of Long Term Care

On January 17, 2012, the FDA approved Voraxaze (glucarpidase) to treat patients with methotrexate-induced nephrotoxicity, a condition to which older patients are more susceptible. Methotrexate is a chemotherapeutic agent that is commonly used to treat breast, skin, head and neck, and lung cancers. High-dose methotrexate use can result in kidney failure, causing toxic levels of methotrexate to accumulate in the blood, which can prove fatal. Administered intravenously, Voraxaze is an enzyme that rapidly reduces the level of methotrexate by breaking it down to a form that the body can eliminate.

“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,” said Richard Pazdur, MD, director, Office of Hematology and Oncology Products, FDA Center for Drug Evaluation and Research, in an FDA press statement. “Voraxaze is an important new treatment option for cancer patients aimed at preventing these toxicities associated with sustained high levels of methotrexate.”

The FDA’s approval of the drug followed the results of a single clinical study of 22 patients who received Voraxaze. The study considered treatment successful if a patient’s methotrexate level dropped below the critical level within 15 minutes and stayed below that level for 8 days. Ten of the 22 patients were considered successfully treated by this standard, but in all patients, the drug eliminated 95% of the methotrexate.

The most common side effects observed in patients using Voraxaze were hypotension, headache, nausea, vomiting, flushing, and parasthesia. Voraxaze is marketed by BTG International, Inc, West Conshohocken, PA.