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Voraxaze Generic Name & Formulations
Legal Class
Rx
General Description
Glucarpidase; 1,000 Units/vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
Carboxypeptidase enzyme.
How Supplied
Single-dose vials—1
Manufacturer
Generic Availability
NO
Voraxaze Indications
Indications
Treatment of toxic plasma methotrexate (MTX) concentrations (>1 micromole per liter) in patients with delayed MTX clearance due to impaired renal function.
Limitations of Use
Not recommended in those who exhibit the expected clearance and expected plasma methotrexate concentration; may result in subtherapeutic exposure.
Voraxaze Dosage and Administration
Adults and Children
<1 month: not established. ≥1 month: Give as bolus IV inj over 5mins. 50Units/kg as a single injection. First 48hrs after glucarpidase: administer same leucovorin dose as given prior to glucarpidase. Beyond 48hrs after glucarpidase: determine leucovorin dose based on the measured MTX concentration. Continue leucovorin until the MTX concentration has been maintained below the leucovorin rescue threshold for a minimum of 3 days.
Voraxaze Contraindications
Not Applicable
Voraxaze Boxed Warnings
Not Applicable
Voraxaze Warnings/Precautions
Warnings/Precautions
Monitor MTX concentrations only by chromatographic methods within 48hrs following administration. Continue hydration and alkalinization of urine as indicated. Pregnancy. Nursing mothers.
Voraxaze Pharmacokinetics
See Literature
Voraxaze Interactions
Interactions
May reduce concentrations of leucovorin, other folate analogs or folate analog metabolic inhibitors. When concomitant leucovorin, give at least 2hrs before or 2hrs after glucarpidase administration.
Voraxaze Adverse Reactions
Adverse Reactions
Paresthesia, flushing, nausea, vomiting, hypotension, headache; rare: hypersensitivity reactions, antibody formation.
Voraxaze Clinical Trials
See Literature
Voraxaze Note
Not Applicable
Voraxaze Patient Counseling
See Literature
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