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 touse fats.

Imiglucerase is available only from your doctor in the following dosageform:

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 willdo. This is a decision you and your doctor will make. For imiglucerase, thefollowing should be considered:

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

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals.

Breast-feeding?It is not known whether imiglucerase passes intohuman breast milk. Although most medicines pass into breast milk in smallamounts, many of them may be used safely while breast-feeding. Mothers whoare taking this medicine and who wish to breast-feed should discuss this withtheir doctor.

Children?Although there is no specific information comparinguse of imiglucerase in children with use in other age groups, this medicineis not expected to cause different side effects or problems in children thanit does in adults.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicines.

Proper Use of This Medicine

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

Dosing?The dose of imiglucerase will be differentfor 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 mustbe 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 overone to two hours. The dose may be repeated several times a week to once every2 weeks, depending on your condition. Later your doctor may lower your dose.

Precautions While Using This Medicine

It is importantthat your doctor check your progress while you are receiving imigluceraseto 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 sideeffects may occur, if they do occur they may need medical attention.

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

Less common

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