Meet Matthew, an osteosarcoma survivor, and learn how Voraxaze was a pivotal part of his successful fight against osteosarcoma. ➔

Meet Matthew, an osteosarcoma survivor, who received Voraxaze. ➔

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Prescribing Information
Important Safety Information
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MECHANISM OF ACTION

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Voraxaze Works in the Circulation to Quickly Clear Methotrexate (MTX) 

Voraxaze and Leucovorin Work Differently, Yet Complementarily 

Voraxaze® (glucarpidase) lowers toxic levels in the extracellular compartment, whereas leucovorin counteracts MTX intracellularly. Only Voraxaze rapidly reduces plasma MTX concentrations by hydrolyzing extracellular MTX. 

When MTX concentrations are too high, no plasma leucovorin concentration may be sufficient to ensure effective cell rescue. 

Voraxaze rapidly cleaves MTX into 2 inactive metabolites to provide a nonrenal pathway for elimination. 

Watch the video to see how Voraxaze works extracellularly. 

Leucovorin Rescue Is Essential, But It Does Not Clear MTX From the Body 

  • Leucovorin provides intracellular rescue, restoring tetrahydrofolate stores and allowing resumption of DNA and RNA synthesis, but it does not clear MTX from the body. 
  • Leucovorin is less effective in the presence of high circulating MTX concentrations, particularly MTX concentrations exceeding 10 µM for ≥48 hours. 
  • Leucovorin is a storage vitamin, and excessive doses may impact future high-dose methotrexate (HDMTX) treatment courses. HDMTX treatment failures have been reported in pediatric patients following high doses of leucovorin. 
Learn More About the Efficacy of Voraxaze
References
1.

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

2.

Howard SC, McCormick J, Pui CH, Buddington RK, Harvey RD. Preventing and managing toxicities of high-dose methotrexate. Oncologist. 2016;21(12):1471-1482.

3.

Ramsey LB, Balis FM, O’Brien MM, et al. Consensus Guideline for use of glucarpidase in patients with high-dose methotrexate induced acute kidney injury and delayed methotrexate clearance. Oncologist. 2018;23(1):52-61.

4.

Fusilev®. Prescribing information. Acrotech Biopharma LLC.; 2020.

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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.