VORAXAZE
Voraxaze (glucarpidase) is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentrations in adult and pediatric patients. It is specifically used for patients experiencing delayed methotrexate clearance due to impaired renal function. The treatment is intended for individuals with plasma methotrexate concentrations greater than 1 micromole per liter that exceed two standard deviations of the mean excretion curve for the administered dose. It is not recommended for patients with expected clearance levels, as reducing concentrations in these individuals may lead to subtherapeutic methotrexate exposure.
How VORAXAZE Works
Voraxaze is a recombinant bacterial enzyme that functions by hydrolyzing the carboxyl-terminal glutamate residue from folic acid and classical antifolates. Specifically, the drug converts methotrexate into its inactive metabolites, 4-deoxy-4-amino-N10-methylpteroic acid (DAMPA) and glutamate. By facilitating this conversion, the enzyme provides an alternate non-renal pathway for methotrexate elimination. This mechanism is utilized in patients undergoing high-dose methotrexate treatment who have developed renal dysfunction.
Details
- Status
- Prescription
- First Approved
- 2012-01-17
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VORAXAZE Approval History
What VORAXAZE Treats
1 indicationsVORAXAZE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Toxic plasma methotrexate concentration in adult and pediatric patients with delayed methotrexate clearance due to impaired renal function
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VORAXAZE FDA Label Details
ProIndications & Usage
FDA Label (PDF)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: 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 s...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.