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|Imiglucerase

IMIGLUCERASE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Cerezyme

In Canada—

• Cerezyme

Category

• Enzyme, glucocerebrosidase, replenisher

Description

Imiglucerase (im-i-GLOO-ser-ase) is used to treat Gaucher"s disease caused by the lack of a certain enzyme, glucocerebrosidase, in the body. This enzyme is necessary for your body to use fats.

Imiglucerase is available only from your doctor in the following dosage form:

• Parenteral
• Injection (U.S. and Canada)

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 imiglucerase, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to alglucerase or imiglucerase. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—It is not known whether imiglucerase passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing use of imiglucerase in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of imiglucerase in the elderly with use in other age groups.

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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Proper Use of This Medicine

This medicine 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 . The following information includes only the average doses of imiglucerase:

• 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.

Precautions While Using This Medicine

It is important that your doctor check your progress while you are receiving imiglucerase to make sure that the dosage is correct for you.

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.

The following side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Less common

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

Revised: 08/13/1998

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