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.
Full Prescribing Information
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®
- 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
|Distributor||Item number||Ordering options||Shipping|
|ASD Healthcare||39453||24 hours/day||Standard or expedited|
|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 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)
Voraxaze® US Open-Label Treatment Protocol (program now closed)
Voraxaze® is no longer available through the open-label intravenous treatment protocol (PR001-CLNpro016), also known as the “US Treatment Protocol.” Therefore, this study is no longer enrolling patients, as Voraxaze® is now commercially available.
For those previously participating in the open-label US treatment protocol, please contact:
CTI Voraxaze® Call Center (24 hrs/7 days):
Tel: +1 877 398 9829
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.
Voraxaze® is to be administered as a single intravenous injection of 50 Units per kg.
Important Safety Information
- 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.
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