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Prescribing Information
Important Safety Information
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Dosing & Administration

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Administration of Voraxaze

Voraxaze® (glucarpidase) dosing should be adjusted based on patient weight. 

Administer Voraxaze as a single bolus intravenous injection of 50 U/kg over 5 minutes. 

†Each vial contains 1,000 units. 
‡Continue to dose patients weighing more than 353 lbs. according to their weight

Reconstitution 

  • Reconstitute 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.

Storage 

  • 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.
  • Contains no preservative and is supplied as a single-use vial.
  • Discard any unused product.
References
1.

Voraxaze®. Prescribing information. BTG International Inc.; 2019.

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Indication and Important Safety Information
Indication and Limitations of Use
  • Voraxaze® is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function
  • Limitations of Use: Voraxaze® is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate
Important Safety Information
WARNINGS AND PRECAUTIONS

Serious Hypersensitivity Reactions

  • Serious hypersensitivity reactions, including anaphylactic reactions, may occur. Serious hypersensitivity reactions occurred in less than 1% of patients

Monitoring Methotrexate Concentration/Interference with Assay

  • Methotrexate concentrations within 48 hours following Voraxaze® administration can only be reliably measured by a chromatographic method due to interference from metabolites. Measurement of methotrexate concentrations within 48 hours of Voraxaze® administration using immunoassays results in an overestimation of the methotrexate concentration

ADVERSE REACTIONS

  • In clinical trials, the most common related adverse events (occurring in >1% of patients) were paresthesia, flushing, nausea and/or vomiting, hypotension and headache

DRUG INTERACTIONS

  • Voraxaze® can decrease leucovorin concentration, which may decrease the effect of leucovorin rescue unless leucovorin is dosed as recommended, and may also reduce the concentrations other folate analogs or folate analog metabolic inhibitors

Please see full Prescribing Information.