Glucarpidase
Glucarpidase is an enzyme used to rapidly lower dangerously high methotrexate levels in the blood when the kidneys cannot clear methotrexate fast enough.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Glucarpidase: Patient Information Guide
A plain-language walkthrough of Glucarpidase — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Glucarpidase is used to rapidly lower methotrexate to safe levels when the kidneys cannot clear it fast enough after high-dose treatment.
- Voraxaze (intravenous injection) is approved to reduce toxic plasma methotrexate concentrations (greater than 1 micromole per liter) in adults and children with delayed methotrexate clearance due to impaired kidney function.
- Voraxaze is not recommended for patients whose methotrexate is clearing normally — lowering levels in those patients could make the cancer treatment less effective.
⚙️How it works▾
Glucarpidase is a lab-made (recombinant) bacterial enzyme. It breaks methotrexate down by clipping off a piece of the molecule, converting it into two inactive substances: DAMPA and glutamate. Because this process doesn't rely on the kidneys, it gives the body an entirely separate pathway to eliminate methotrexate — critical when kidney function is too impaired to do it on its own.
💊How it's taken▾
Voraxaze is given as a single intravenous (IV) injection over 5 minutes in a hospital or clinical setting — it is not taken by mouth or self-administered at home. The IV line is flushed before and after the injection. Your care team will continue monitoring your methotrexate levels using the correct type of blood test and will adjust your leucovorin treatment based on those readings. Follow all instructions from your prescriber and care team exactly.
🤒Side effects — in detail▾
The most common side effects reported with Voraxaze include:
- Tingling or numbness (paresthesia)
- Flushing, feeling hot, or a burning sensation
- Nausea and/or vomiting
- Headache
- Low blood pressure (hypotension)
- Blurred vision
Serious allergic reactions have occurred in less than 1% of patients — get immediate medical help if you have trouble breathing, swelling, or feel faint during or after the infusion.
⚠️Warnings & precautions▾
- Serious allergic (hypersensitivity) reactions: Though rare (less than 1% of patients), serious reactions can happen. You will be monitored closely by your care team during and after the injection.
- Inaccurate methotrexate blood tests for 48 hours: After Voraxaze, a byproduct called DAMPA interferes with the standard immunoassay blood test for methotrexate, causing it to read falsely high. For up to 48 hours after your dose, only a chromatographic test gives an accurate methotrexate level. Your care team is responsible for using the right test — this is important so that leucovorin dosing decisions are made correctly.
🔀What it interacts with▾
Voraxaze has two key interactions your care team needs to manage carefully:
- Leucovorin (folinic acid): Voraxaze can lower leucovorin levels in the blood. To protect the effectiveness of leucovorin rescue, leucovorin must be given at least 2 hours before or 2 hours after the Voraxaze dose — not at the same time. Your leucovorin schedule will be adjusted by your care team around the Voraxaze dose.
- Other folate analog drugs: Voraxaze may also reduce the levels of other medications that are folate analogs or folate analog metabolic inhibitors — make sure your care team knows all medications you are taking.
- Methotrexate immunoassay tests: Voraxaze causes DAMPA to appear in the blood, which falsely inflates immunoassay readings for methotrexate for up to 48 hours — chromatographic testing must be used during this window for accurate results.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: There are no human data on Voraxaze use in pregnancy. Voraxaze is given alongside methotrexate, which is known to cause harm to a developing baby — discuss risks with your doctor.
- Breastfeeding: It is not known whether glucarpidase passes into breast milk. Voraxaze is given with methotrexate, which carries its own breastfeeding risks — ask your doctor before breastfeeding.
- Children: Voraxaze is approved for pediatric patients and has been studied in children from 1 month to 17 years of age. No overall differences in safety were found compared to adults.
- Older adults: Patients 65 and older received Voraxaze in clinical studies with no overall differences in safety or effectiveness compared to younger adults.
- Kidney impairment: Voraxaze is specifically used in patients with impaired kidney function — it does not require dose adjustment for renal impairment based on available pharmacokinetic data.
📡Pharmacodynamics — effects in the body▾
After a single Voraxaze dose, methotrexate levels measured by a chromatographic method dropped by 97% or more within just 15 minutes in clinical study patients. This reduction was sustained — more than 95% below pre-treatment levels — for up to 8 days in nearly all patients studied. This rapid, sustained reduction is what makes Voraxaze effective at rescuing patients from methotrexate toxicity.
🔬Pharmacokinetics — how your body processes it▾
After intravenous injection, glucarpidase distributes into a relatively small volume — meaning it stays fairly concentrated in the bloodstream rather than spreading widely into tissues. Its activity in the blood declines with a half-life of about 5 to 6 hours, while total glucarpidase concentration has a somewhat longer half-life of about 9 hours. The drug is cleared from the body with a mean systemic clearance of 7.5 mL/min. In patients with severe kidney impairment, the pharmacokinetics of glucarpidase itself are not significantly affected — the kidneys do not appear to play a major role in clearing glucarpidase from the body.
📦How to store it▾
Store VORAXAZE refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze.
📄 Written from Glucarpidase’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Glucarpidase — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Voraxaze do, and why do I need it? ▾
How is Voraxaze given, and will I need more than one dose? ▾
What side effects should I watch out for after getting Voraxaze? ▾
I'm also getting leucovorin — does Voraxaze affect that? ▾
Why does my doctor need to use a special blood test to check methotrexate levels after Voraxaze? ▾
Is Voraxaze safe for children, and are there concerns about pregnancy? ▾
Is Glucarpidase available over the counter? ▾
When was Glucarpidase first available? ▾
Who makes Glucarpidase? ▾
💬 Answers drafted from Glucarpidase’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Glucarpidase comes
Glucarpidase is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Voraxaze is used intravenously to reduce toxic plasma methotrexate concentrations (above 1 micromole per liter) in adults and children whose kidneys are not clearing methotrexate fast enough after high-dose treatment.
- Voraxaze is not indicated for patients who are clearing methotrexate at the expected rate.
- Voraxaze is given as a single intravenous injection administered over 5 minutes by a healthcare provider.
- Voraxaze: flush the IV line before and after administration.
- Voraxaze must be reconstituted with 1 mL of 0.9% Sodium Chloride — roll and tilt gently to mix, do not shake; use immediately or refrigerate for up to 4 hours.
- When given alongside leucovorin, Voraxaze requires leucovorin to be administered at least 2 hours before or 2 hours after the Voraxaze dose.
Oral solution
📊 Glucarpidase across the U.S. market
How Glucarpidase appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Glucarpidase products
A representative set of FDA-listed product records for Glucarpidase — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1000 [USP'U] | Intravenous | BTG International Inc. × 2 listings | BLA | View NDC → |
| 💊Oral solution | ||||
| GLUCARPIDASE 1000 U/mL | — | Kaneka Eurogentec SA | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Glucarpidase NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Glucarpidase — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Glucarpidase in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Glucarpidase went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1242127 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1739546In current FDA listingsClinical drug / strength (SCD) 1000 UNTRxCUI 1242131
Look up RxCUI 1242127 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Glucarpidase is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Glucarpidase belongs to the Carboxypeptidase class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. BTG International Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.