Quick answers
- What is Glucarpidase used for?
- The FDA-approved label (Voraxaze, BTG International Inc., November 27, 2024) says: “VORAXAZE 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Glucarpidase have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Glucarpidase?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Glucarpidase been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Glucarpidase?
- 1 company lists prescription products of Glucarpidase in the FDA NDC Directory, including BTG International Inc.
What Glucarpidase is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VORAXAZE 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 …
— FDA label: Voraxaze, BTG International Inc., effective November 27, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Voraxaze |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- BTG International Inc1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125327 VORAXAZE | Btg International Inc | January 17, 2012 | 2, latest August 13, 2019 2019: Labeling · 2013: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1242131, 1242136 |
|---|---|
| SPL set ID of the quoted label | acaef5a6-b740-40e3-8ffe-74a75c74745c |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125327 |
| Active ingredients (FDA) | GLUCARPIDASE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Voraxaze, BTG International Inc., effective November 27, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →