Glucarpidase (intravenous route)


    Brand Name

    US Brand Name

    Voraxaze


    Description

    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.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using

    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.

    Pediatric

    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.

    Geriatric

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

    Breastfeeding

    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.

    Drug Interactions

    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

    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

    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

    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.






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