Pronunciation:

gloo-KARP-i-dase

Brand Names:

• Voraxaze

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Methotrexate Rescue

Pharmacologic—

Enzyme

Uses of This Medicine:

Glucarpidase injection is used to treat too much methotrexate concentration in the blood in patients with severe kidney disease.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glucarpidase injection in children. However, safety and efficacy have not been established in children younger than 1 month of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glucarpidase injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Leucovorin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

If you are also using leucovorin, wait at least 2 hours before or after receiving glucarpidase injection.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects. Be sure to keep all appointments.

Serious allergic reactions may occur during treatment with glucarpidase. Check with your doctor right away if you have a fever; chills; flushing of the face; headache; hives; itching; rash; tightness of the throat; tingling or numbness sensation; troubled breathing; rash; swelling of the face, tongue, and throat; or chest pain after you receive the medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

unusual tiredness or weakness

Rare

Cough

difficulty with swallowing

dizziness

fever

headache

hives

hoarseness

irritation

itching

joint pain, stiffness, or swelling

nervousness

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rash

redness of the skin

shortness of breath

slow or fast heartbeat

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled breathing or swallowing

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

feeling of warmth

nausea

redness of the face, neck, arms, and occasionally, upper chest

vomiting

Rare

Diarrhea

shakiness in the legs, arms, hands, or feet

sore throat

trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.