FDA Logo Methotrexate is a chemotherapy drug that is generally discarded from the body via the kidneys. However, those receiving high dosage of the drug consequently develop kidney failure. Coming as an aid for such patients, the US food and Drug administration (FDA) has approved of Voraxaze for treating patients with harmful levels of methotrexate in their bloodstreams.

The enzyme Voraxaze apparently lowers methotrexate levels by breaking down the medicine into a form that can removed from the body. This enzyme is supposed to be administered into the patient’s vein directly.

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

The aforesaid medication is usually referred to as an orphan drug owing to its usage only in case of unusual or particular disease incidences. To provide the approval, the team included 22 patients in a trial. The scientists aimed for a reduction in methotrexate levels below the threshold that is considered to be destructive. Also, they were anticipating this effect to sustain itself for a span of 8 days.

Though 10 out of the 22 patients seemingly managed to carry appropriate levels of methotrexate, the others did not successfully achieve the target. Nevertheless, Voraxaze appeared to be responsible for eliminating approximately 95% of methotrexate in all the study participants.

As for the side effects, there were reports of low blood pressure, flushing, headache, vomiting, nausea and abnormal sensations among patients using Voraxaze. The drug is marketed by BTG International.