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Voraxaze (GLUCARPIDASE)
Voraxaze works by breaking down the chemotherapy medication methotrexate into a less toxic form.
Voraxaze (GLUCARPIDASE) is a small molecule carboxypeptidase developed by BTG INTERNATIONAL INC, approved by the FDA in 2012 for reducing toxic plasma methotrexate concentrations. It works by breaking down methotrexate, a chemotherapy medication, to prevent its toxic effects. Voraxaze is used to treat patients who have experienced high levels of methotrexate in their blood, often due to overdose or impaired kidney function. The commercial status of Voraxaze is patented, and its half-life is approximately 5.6 hours. Key safety considerations include the potential for allergic reactions and the need for careful dosing.
At a glance
| Generic name | GLUCARPIDASE |
|---|---|
| Sponsor | Btg International Inc |
| Drug class | Carboxypeptidase [EPC] |
| Modality | Enzyme |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2012 |
Mechanism of action
Glucarpidase is recombinant bacterial enzyme that hydrolyzes the carboxyl- terminal glutamate residue from folic acid and classical antifolates such as methotrexate.Glucarpidase converts methotrexate to its inactive metabolites 4-deoxy-4-amino-N10- methylpteroic acid (DAMPA) and glutamate. VORAXAZE provides an alternate non-renal pathway for methotrexate elimination in patients with renal dysfunction during high-dose methotrexate treatment.
Approved indications
- Toxic plasma methotrexate concentration reduction
Common side effects
- Paresthesia
- Nausea/Vomiting
- Flushing
- Headache
- Hypotension
- Blurred Vision
- Diarrhea
- Hypersensitivity
- Hypertension
- Rash
- Throat irritation/Throat tightness
- Tremor
Key clinical trials
- Testing the Safety of the Anti-cancer Drug, Sn-117m-DTPA, for Advanced Cancers That Have Spread to Bones (PHASE1)
- Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer (NA)
- LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma (EARLY_PHASE1)
- Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study (PHASE2)
- Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (PHASE2)
- Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (PHASE2)
- MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer (PHASE2)
- MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |