Voraxaze
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
VORAXAZE (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.
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.
History
There is currently no drug history available for this drug.
Other Information
VORAXAZE (glucarpidase) is a carboxypeptidase produced by recombinant DNA technology in genetically modified Escherichia coli. Glucarpidase is a 390-amino acid homodimer protein with a molecular weight of 83 kDa. Each potency Unit corresponds to the enzymatic cleavage of 1 μmol/L of methotrexate per minute at 37°C.
VORAXAZE is supplied as a sterile, preservative-free, white lyophilized powder in single-use vials. Each vial contains 1,000 Units of glucarpidase, lactose monohydrate (10 mg), Tris-HCl (0.6 mg) and zinc acetate dihydrate (0.002 mg).
Sources
Voraxaze Manufacturers
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Btg International Inc.
![Voraxaze (Glucarpidase) Injection, Powder, For Solution [Btg International Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Voraxaze | Btg International Inc.
2.1 Recommended DoseAdminister VORAXAZE as a single intravenous injection of 50 Units per kg.
2.2 AdministrationAdminister VORAXAZE intravenously as a bolus injection over 5 minutes. Flush intravenous line before and after administration of VORAXAZE.
2.3 Preparation Reconstitute the contents of the vial with 1 mL of sterile saline for injection, USP. Roll and tilt the vial gently to mix. Do not shake. Inspect the vial and discard VORAXAZE if the solution is not clear, colorless, and free of particulate matter. Use reconstituted VORAXAZE immediately or store under refrigeration at 36° to 46°F (2° to 8°C) for up to 4 hours if not used immediately. VORAXAZE contains no preservative and is supplied as a single-use vial. Discard any unused product.[see How Supplied/Storage and Handling (16)]
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