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Voraxaze

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Voraxaze

INDICATIONS

Indication

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.

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 AND ADMINISTRATION

Recommended Dose

Administer VORAXAZE as a single intravenous injection of 50 Units per kg.

Administration

Administer VORAXAZE intravenously as a bolus injection over 5 minutes. Flush intravenous line before and after administration of VORAXAZE.

Preparation

  1. Reconstitute the contents of the vial with 1 mL of sterile saline for injection, USP.
  2. Roll and tilt the vial gently to mix. Do not shake.
  3. Inspect the vial and discard VORAXAZE if the solution is not clear, colorless, and free of particulate matter.
  4. 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 Storage and Handling].

HOW SUPPLIED

Dosage Forms And Strengths

Lyophilized powder 1,000 Units per vial

Storage And Handling

VORAXAZE is supplied as a sterile, preservative-free white lyophilized powder in an individually packaged glass vial closed with a bromo butyl elastomeric stopper and blue flip-off seal.

1,000 Units of glucarpidase per vial (1 vial per carton) NDC 50633-210-11

Store VORAXAZE at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not use VORAXAZE after the expiration date on the vial.

Manufactured by: BTG International Inc., Brentwood, TN 37027. Distributed by: BTG International Inc., West Conshohocken, PA 19428. Revised: March 2013

Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.

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Additional Voraxaze Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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