Drug updated on 4/15/2024
| Dosage Form | Injection (intravenous; 1,000 units/vial) |
| Drug Class | Carboxypeptidases |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.
Summary
- Glucarpidase (Voraxaze) is indicated for the treatment of toxic plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function. It provides a targeted approach to rapidly reducing methotrexate levels, presenting itself as a potentially safer and more effective alternative to extracorporeal treatments.
- The utility of glucarpidase compared to extracorporeal treatments in managing severe methotrexate toxicity was evaluated in a systematic review/meta-analysis.
- Compared with other management strategies such as intravenous hydration and folinic acid, glucarpidase is recommended over extracorporeal methods, which mainly remove drugs from the intravascular compartment without significantly addressing drugs that distribute into cells like methotrexate does.
- A study cited within the systematic review suggests lower mortality rates among patients treated with glucarpidase than those treated with hemodialysis. However, limitations were noted regarding study design and evidence quality.
- Despite these limitations, there is an overall recommendation against using extracorporeal treatments when glucarpidase is available, based on its potential effectiveness and safety profile, especially for patients suffering from high-dose methotrexate toxicity coupled with impaired renal function.
- The data reviewed included 109 patients receiving varying doses of Methotrexate (>0.5 g/m² or ≤0.5 g/m²), indicating consideration across different levels of exposure; reported mortality rates were 19.5% for high-dose users versus 26.7% for low-dose users, highlighting severity conditions addressed by this drug treatment option.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Voraxaze (glucarpidase) Prescribing Information. | 2019 | BTG International Inc., Brentwood, TN |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Extracorporeal treatment for methotrexate poisoning systematic review and recommendations from the EXTRIP workgroup. | 2022 | Clinical Journal of the American Society of Nephrology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Incidence and management of patients with methotrexate delayed elimination in the clinical practice: A Delphi study. | 2023 | Journal of Oncology Pharmacy Practice |
| Chapter 3: Management of kidney injury caused by cancer drug therapy, from clinical practice guidelines for the management of kidney injury during anticancer drug therapy 2022. | 2023 | International Journal of Clinical Oncology |
| BTG pharmaceuticals statement on NCCN clinical practice guidelines in oncology (NCCN guidelines®) recommendation for use of glucarpidase (Voraxaze®) and MTXPK.org. | 2023 | SERB Pharmaceuticals |
| DAMPAned methotrexate: a case report and review of the management of acute methotrexate toxicity. | 2019 | Canadian Journal of Kidney Health and Disease |