VORAXAZE (glucarpidase) For Injection, for intravenous use. Initial U.S. Approval: 2012

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VORAXAZE (glucarpidase) For Injection, for intravenous use. Initial U.S. Approval: 2012

INDICATIONS AND USAGE
• VORAXAZE® (glucarpidase) is a carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.
• Limitation of use: VORAXAZE is not indicated for use in patients who exhibit the expected clearance of methotrexate (plasma methotrexate concentrations within 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate.
DOSAGE FORMS & STRENGTHS
Lyophilized powder 1,000 Units per vial
Manufactured By: BTG International Inc.
Prescribing Information URL: Click Here

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Glucarpidase (Voraxaze) is an FDA-approved intravenous drug for the treatment of elevated levels of methotrexate (defined as 1 micromol/L) during treatment of cancer patients who have impaired kidney function (and thus cannot reduce the drug to safe levels sufficiently after the drug has been given). Glucarpidase is an enzyme that inactivates methotrexate rapidly after injection.

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