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Prescribing Information
Important Safety Information
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Voraxaze® (glucarpidase)
EFFICACY

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Voraxaze Lowers Plasma Methotrexate (MTX) Levels by ≥97% in 15 Minutes 

At each post-Voraxaze assessment time point, the median MTX concentration was <0.54 μM, corresponding to a median reduction of ≥97% from pre-Voraxaze measurements. 

Voraxaze® (glucarpidase) reduced plasma MTX concentrations by ≥97% within 15 minutes in all 22 treatment-evaluable patients. 

Reductions in Plasma MTX Concentrations Were Sustained for up to 8 Days ,*

91% (20/22) of patients who received Voraxaze achieved a >95% reduction in plasma MTX concentrations within 15 minutes of administration that lasted for up to 8 days. 

77% (10/13) of patients with MTX levels ≤50 μM who received Voraxaze achieved a reduction of MTX levels to ≤1 μM within 15 minutes of administration that lasted for up to 8 days. 

*Results are from a single-arm, open-label study in 22 treatment-evaluable patients with markedly delayed MTX clearance secondary to acute kidney injury. The primary endpoint of the study was the proportion of patients achieving an MTX plasma concentration of ≤1 μM at 15 minutes that was sustained for up to 8 days following the initial injection. 

Early Administration of Voraxaze May Diminish the Risk for Serious Life-Threatening Toxicity and Even Death 

Incidence of Grade 4 toxicity was significantly lower with early administration of Voraxaze. 

  • Administration of Voraxaze ≤4 days after high-dose methotrexate (HDMTX) exposure appeared to protect from the development of toxicity. 
  • Only 14% (9/64) of patients who received early treatment (within 4 days of HDMTX infusion) with Voraxaze experienced Grade 4 toxicity, compared with 55% (6/11) who received later treatment. 

Incidence of mortality was significantly lower with early administration of Voraxaze. 

  • Of 476 patients receiving Voraxaze, death occurred in 22% of patients treated after 4 days following HDMTX infusion compared with 10.9% treated within 2 days of HDMTX infusion. 
  • There are no controlled trials comparing Voraxaze plus supportive care to supportive care measures alone in patients with toxic plasma MTX concentrations due to impaired renal function; therefore, there are no data regarding the effect of Voraxaze on survival or toxic death due to MTX. Voraxaze did not prevent fatal MTX toxicity in 3% of patients in the safety population. 

See How Well Your Patient Is Clearing MTX – Before the Critical Window

MTX Monitoring Tool

Voraxaze Delivered Clinically Important MTX Reductions in Markedly Less Time 

Treatment with Voraxaze vs standard supportive care alone reduces plasma MTX within 15 minutes vs 11 ± 3 days. 

Trust Voraxaze for Rapid and Sustained Reductions in MTX 

Not every patient requires Voraxaze, but experts have assembled recommendations to help guide treatment.

Explore guidelines for the use and stocking of Voraxaze so that you’re prepared in an emergency.

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References
1.

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

2.

Widemann BC, Schwartz S, Jayaprakash N, et al. Efficacy of glucarpidase (carboxypeptidase G2) in patients with acute kidney injury after high-dose methotrexate therapy. Pharmacotherapy. 2014;34(5):427-439.

3.

Widemann BC, Balis FM, Kim A, et al. Glucarpidase, leucovorin, and thymidine for high-dose methotrexate-induced renal dysfunction: clinical and pharmacologic factors affecting outcomes. J Clin Oncol. 2010;28(25):3979-3986.

4.

Ward S, King T, Chauhan N. Pooled analysis of time to administration of glucarpidase for methotrexate toxicity versus mortality. Clin Toxicol. 2013;51(7):575-724. Abstract 7.

5.

Murashima M, Adamski J, Milone MC, et al. Methotrexate clearance by high-flux hemodialysis and peritoneal dialysis: a case report. Am J Kid Dis. 2009;53(5):871-874.

6.

Wall SM, Johansen MJ, Molony DA, DuBose TD, Jaffe N, Madden T. Effective clearance of methotrexate using high-flux hemodialysis membranes. Am J Kid Dis. 1996;28(6):846-854.

7.

Flombaum CD, Meyers PA. High-dose leucovorin as sole therapy for methotrexate toxicity. J Clin Oncol. 1999;17(5):1589-1594.

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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.