Voraxaze® (glucarpidase)

Voraxaze® (glucarpidase)

Voraxaze® (glucarpidase)

Voraxaze® (glucarpidase) is commercially available in the US where it 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. 

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Full Prescribing Information
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How to order Voraxaze®

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  • To place an order for Voraxaze®, please contact the BTG Specialty Solutions Center at 1.844.293.0007, 24 hours/day, 7 days/week.
  • ASD Healthcare is the only specialty distributor of Voraxaze®. They fill orders for both stocking purposes or expedited shipping.
  • AmerisourceBergen, Cardinal Health, and McKesson customers may order Voraxaze® on a drop-ship basis. These orders can only be processed during regular business hours and sent via overnight delivery.
  • You may also email Voraxaze@btgplc.com for questions about your order.
Distributor  Item number Ordering options  Shipping
ASD Healthcare  39453  24 hours/day  Standard or expedited
AmerisourceBergen  10129337 or 255385 Normal business hours Drop-ship only
Cardinal  4725370  Normal business hours  Drop-ship only
McKesson  2038743  Normal business hours Drop-ship only

How Voraxaze® is supplied

NDC# Dosing Strength Form No. of Items/Container 
50633-210-11  50 Units/kg 1000 Units/vial  Lyophylized powder 1 vial/carton

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:

Adverse Reactions:

  • Serious allergic reactions, including anaphylactic reactions, may occur.
  • The most common adverse reactions (incidence >1%) with Voraxaze® are paraesthesias, flushing, nausea and/or vomiting, hypotension, and headache.

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.

BTG Specialty Solutions Center is a trademark of BTG International Ltd.

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