Voraxaze is used in patients who develop kidney failure while receiving high doses of methotrexate (a chemotherapy drug).

Voraxaze is an enzyme that breaks down methotrexate in the body so the drug can be easily eliminated when the kidneys are not working properly.

Voraxaze may also be used for purposes not listed in this medication guide.

If possible before you receive Voraxaze, tell your doctor if you are also being treated with leucovorin.

Tell your caregiver right away if you have any symptoms of a reaction to the Voraxaze injection: severe dizziness or weakness, severe nausea, cold sweat, itching, numbness or tingly feeling, sudden headache, fast heartbeats, chest tightness, trouble breathing, or if you feel like you might pass out.

Voraxaze is given as an infusion into a vein. A healthcare provider will give you this injection. Voraxaze is usually given as a single injection. The IV infusion will take about 5 minutes to complete.

You may also be given a medicine called leucovorin, either 2 hours before or 2 hours after you receive a Voraxaze injection.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any follow-up visits to your doctor.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using glucarpidase.

Usual Adult Dose for Methotrexate Overdosage:

Single IV injection of 50 Units/kg

Use: Treatment of toxic plasma methotrexate concentrations (greater than 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.

Usual Pediatric Dose for Methotrexate Overdosage:

Children 1 month of age or older: Single IV injection of 50 units/kg

Use: Treatment of toxic plasma methotrexate concentrations ( greater than 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.

If possible before you receive Voraxaze, tell your doctor if you are also being treated with leucovorin.

In an emergency, you may not be able to tell caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received this medicine.

Since Voraxaze is used as a single dose, it does not have a daily dosing schedule.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Voraxaze: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregiver right away if you have any symptoms of a reaction to the Voraxaze injection: severe dizziness or weakness, severe nausea, cold sweat, itching, numbness or tingly feeling, sudden headache, fast heartbeats, chest tightness, trouble breathing, or if you feel like you might pass out.

Common Voraxaze side effects may include:

• nausea, vomiting;

• numbness, tingling, burning pain; or

• flushing (sudden warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with glucarpidase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.