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Voraxaze® (glucarpidase)

NOW COMMERCIALLY AVAILABLE!

Recently launched in the US, 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® breaks down methotrexate into inactive metabolites which are then eliminated from the body by routes other than the kidney (primarily the liver). Voraxaze® is the first and only drug available to reduce toxic plasma methotrexate levels.

Voraxaze Logo

 

 

 


Full Prescribing Information
Download pdf

Press Releases:

5 September 2012
CMS grants new prospective reimbursement for Voraxaze®

4 June 2012
BTG announces data presentation on Voraxaze® (glucarpidase) at the American Society of Clinical Oncology Annual Meeting

30 April 2012
Voraxaze® (glucarpidase) launched in the US

18 January 2012
Voraxaze® (glucarpidase) receives US regulatory approval

 

How to order Voraxaze®Voraxaze Product Shot

  • ASD Healthcare is currently the sole specialty distributor of Voraxaze®
  • To place an order through ASD Healthcare or for related questions about Voraxaze®, please contact Voraxaze® Customer Service at +1.855.7.VORAXAZE (+1.855.786.7292); available 24 hours/day, operating 365 days/year
    -- ASD fills orders for both stocking purposes or expedited shipping
  • Voraxaze® is available to AmerisourceBergen, Cardinal, and McKesson customers on a drop-ship basis
    -- These orders can only be processed during normal business hours and are only available for overnight delivery


DistributorItem numberOrdering optionsShipping
ASD Healthcare3945324 hours/dayStandard or expedited
AmerisourceBergen10129337
or 255385
Normal business hoursDrop-ship only
Cardinal4725370Normal business hoursDrop-ship only
McKesson2038743Normal business hoursDrop-ship only


How Voraxaze® is supplied

NDC#DosingStrengthFormNo. of Items/Container
50633-210-1150 Units/kg1000 Units/vialLyophylized powder1 vial/carton


Click here for BTG’s letter to customers regarding extension of Voraxaze® Lot# 2162-104A.

Click here to download the Material Safety Data Sheet for Voraxaze®

Voraxaze® Medical Information

For any medical information inquiries on Voraxaze® please contact:
Voraxaze® Medical Call Center:
Tel: +1 877 377 3784 (24 hrs/7 days)
Email: medical.services@btgplc.com

 

General Information

Indications and Use

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 or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate.

Dosing

Voraxaze® is to be administered as a single intravenous injection of 50 Units per kg.

Important Safety Information

Adverse Reactions:

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

Warnings and Precautions:

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylactic reactions, may occur.

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 can overestimate the methotrexate concentration.

Continuation and Timing of Leucovorin Rescue

  • Leucovorin should not be administered within 2 hours before or after Voraxaze® dose because leucovorin is a substrate for Voraxaze®.1
  • For the first 48 hours after Voraxaze®, administer the same leucovorin dose as given prior to Voraxaze®.
  • Beyond 48 hours after Voraxaze®, administer leucovorin based on the measured methotrexate concentration.
  • Do not discontinue therapy with leucovorin based on the determination of a single methotrexate concentration below the leucovorin treatment threshold.
  • Therapy with leucovorin should be continued until the methotrexate concentration has been maintained the leucovorin treatment threshold for a minimum of 3 days.
  • Continue hydration and alkalinization of the urine as indicated.

Reference:

  1. Voraxaze® (glucarpidase) prescribing information March 2013

To report SUSPECTED ADVERSE REACTIONS, call +1 877 377 3784 or contact FDA at
+1 800 FDA 1088 or www.fda.gov/medwatch.

 

Click here to read more about High-Dose Methotrexate Clearance and Toxicity.

 

Voraxaze® is a registered trademark of Protherics Medicines Development Ltd
BTG and the BTG roundel logo are registered trademarks of BTG International Ltd

High-Dose Methotrexate
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Learn more about high-dose methotrexate clearance and toxicity.

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