The FDA has approved the orphan drug Voraxaze (glucarpidase injection; BTG International) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Patients receiving high dose methotrexate chemotherapy may develop kidney failure, reducing their ability to clear methotrexate from the body. Other consequences of methotrexate toxicity include liver damage, severe mouth sores, damage to the lining of the intestine, skin rashes, and death due to low blood counts. Voraxaze is an enzyme that rapidly reduces methotrexate levels by breaking it down to a form that can be eliminated from the body.
This approval was based on results from a single clinical study involving 22 patients. Treatment with Voraxaze was considered to be successful if the methotrexate level fell below a critical level within 15 minutes and stayed below the critical level for eight days. Ten of the 22 patients achieved this standard. Although not all patients experienced this result, Voraxaze eliminated 95% of the methotrexate in all patients. The safety of Voraxaze was also evaluated in a separate study involving 290 patients experiencing problems clearing methotrexate from their blood.
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