Prescription medicine
Glucarpidase Brand names: Voraxaze
Glucarpidase (Voraxaze) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the glucarpidase FDA label on DailyMed (effective November 27, 2024, BTG International Inc.); the BLA 125327 record on Drugs@FDA; every glucarpidase label on DailyMed.
Highlights of the record
FDA label of November 27, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVORAXAZE is 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.
Forms and strengths
Injection (powder) for solution.
On the market
- Earliest approval on file
- January 17, 2012 Voraxaze, Btg International Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 358 through July 30, 2026
What is glucarpidase used for?
From the label: indications and usageVORAXAZE is 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 [see Clinical Studies ( 14 )]. […]
FDA pharmacologic class: Carboxypeptidase.
Source: FDA drug label (Voraxaze), BTG International Inc., effective November 27, 2024 (SPL set acaef5a6-b740-40e3-8ffe-74a75c74745c), via openFDA; the full label on DailyMed
Is there a generic for glucarpidase (Voraxaze)?
No generic glucarpidase is approved (Drugs@FDA, October 8, 2026).
- 2012 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the glucarpidase label say about other medicines?
The glucarpidase label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name glucarpidase. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Leucovorin | drug interactions | DRUG INTERACTIONS 7.1 Effects of VORAXAZE on Leucovorin VORAXAZE can decrease leucovorin concentration, which may decrease the effect of leucovorin rescue unless leucovorin is dosed as recommended [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )]. |
| Methotrexate | drug interactions | Measurement of Methotrexate Concentration DAMPA (4-deoxy-4-amino-N10- methylpteroic acid), an inactive metabolite of methotrexate formed following VORAXAZE administration, interferes with the measurement of methotrexate concentration using immunoassays. |
Source: FDA drug label (Voraxaze), BTG International Inc., effective November 27, 2024 (SPL set acaef5a6-b740-40e3-8ffe-74a75c74745c), via openFDA; the full label on DailyMed
What do FAERS reports show for glucarpidase?
The FDA Adverse Event Reporting System holds 358 reports that list glucarpidase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 70 are coded as a death and 84 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Glucarpidase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other