Cytoprotective and supportive care agents:

Indications for VORAXAZE:

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.

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.

Warnings/Precautions:

Monitor MTX concentrations only by chromatographic methods within 48hrs following administration. Continue hydration and alkalinization of urine as indicated. Pregnancy. Nursing mothers.

Pharmacologic Class:

Carboxypeptidase enzyme.

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.

Adverse Reactions:

Paresthesia, flushing, nausea, vomiting, hypotension, headache; rare: hypersensitivity reactions, antibody formation.

Generic Availability:

NO

How Supplied:

Single-dose vials—1