Imiglucerase Intravenous

In the U.S.

• Cerezyme

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Enzyme

imiglucerase helps control and reverse problems caused by Gaucher's disease. Therefore, you must continue to receive it if you expect to keep your condition under control. You may have to receive imiglucerase for the rest of your life. If Gaucher's disease is not treated, it can cause serious blood, liver, skeletal, or spleen problems.

Dosing

The dose of imiglucerase will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of imiglucerase. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For Gaucher's disease:
  • For injection dosage form:
    • Adults and children—The dose is based on body weight and must be determined by your doctor. The usual dose is 15 to 60 Units per kilogram (kg) (6.8 to 27 Units per pound) of body weight injected into a vein over one to two hours. The dose may be repeated several times a week to once every 2 weeks, depending on your condition. Later your doctor may lower your dose.

Fever, headache, nausea, vomiting, swelling of the hands/feet (edema), or redness/pain/itching/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, flushing, chest pain, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., IgG antibodies) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Before mixing, store the vial in the refrigerator. Protect from light and freezing.

Once mixed, consult the product instructions and your pharmacist for storage details. Discard any unused portion. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.