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Prescribing Information
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Expert Guidelines

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Consensus Guidelines Recommend Early Use of Voraxaze 

Consensus guidelines for use recommend administration of Voraxaze®(glucarpidase) at 48 hours following initiation of high-dose methotrexate (HDMTX) therapy when MTX concentrations are above 5 μM (2.27 μg/mL) and the serum creatinine is elevated relative to the baseline measurement. 

Beyond 48 to 60 hours, life-threatening toxicities and even death may not be preventable. Early and rapid reduction of methotrexate (MTX) concentrations can lower the risk of irreversible damage. 

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High-Dose Methotrexate (HDMTX) Monitoring Guideline and Voraxaze Treatment Algorithm 

High-Dose Methotrexate (HDMTX) Monitoring Guideline and Voraxaze Treatment Algorithm

*For MTX doses of 1-8 g/m2 over 24 hours, if MTX concentration is >120 μM or CrCl is greater than 1.5x baseline, continue supportive care and check MTX concentration at 36 hours1. CrCl, creatinine clearance.

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Expert Consensus Guidelines Recommend Having 5 Vials of Voraxaze Readily Available 

  • Expert Consensus Guidelines published in 2018 recommend that all hospitals that provide emergency care should stock 5 vials of Voraxaze. 
  • The Institute for Safe Medication Practices (ISMP) recommends that all appropriate antidotes should be readily available. 
  • Standardized protocols and/or a coupled order should be set in place that permit the emergency administration of all appropriate antidotes used in the facility. 

Stock Voraxaze According to Guidelines

Not every patient requires Voraxaze, but having it on hand can help you be prepared in an emergency.

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View a Roadmap to Management of Patients With Delayed MTX Clearance

Download PDF: HDMTX Roadmap for Success
References
1.

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.

2.

Dart RC, Goldfrank LR, Erstad BL, et al. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Ann Emerg Med. 2018;71(3):314-325.

3.

Institute for Safe Medication Practices. ISMP Targeted Medication Safety Best Practices for Hospitals. 2020-2021. Accessed March 15, 2024. https://www.ismp.org/sites/default/files/attachments/2020-02/2020-2021%20TMSBP-%20FINAL_1.pdf

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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

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