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|Alglucerase

ALGLUCERASE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Ceredase

In Canada—

• Ceredase

Category

• Enzyme, glucocerebrosidase, replenisher

Description

Alglucerase (al-GLOO-ser-ace) 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.

Alglucerase is made from human placenta tissue that is collected after a baby is born. Before it is used, the tissue is tested for hepatitis and human immunodeficiency virus (HIV). This is similar to the testing that a blood bank does on donated blood before it is given to anyone else.

Alglucerase is available with your doctor"s prescription, in the following dosage form:

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

Before Receiving This Medicine

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

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

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

Breast-feeding—It is not known whether alglucerase passes into human breast milk.

Children—This medicine has been tested in a limited number of children. In effective doses, the medicine has not been shown to cause different side effects or problems 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 alglucerase 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 will not cure Gaucher"s disease but it does help control it. Therefore, you must continue to receive it if you expect to keep your condition under control. You may have to receive alglucerase 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 alglucerase will be different for different patients. Follow your doctor"s orders . The following information includes only the average doses of alglucerase.

• For Gaucher"s disease:
  • For injection dosage form:
    • Adults and children—The dose is based on body weight. It is injected slowly into a vein over one to two hours. To start, some patients may receive 1.15 Units per kilogram (kg) (0.52 Units per pound) of body weight three times a week. Other patients may receive up to 60 Units per kg (27 Units per pound) of body weight as often as once a week or as seldom as every four weeks. Later, your doctor may raise or lower your dose.

Precautions While Receiving This Medicine

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

Side Effects of This Medicine

Since alglucerase is made from human tissue, it is possible that diseases caused by viruses could be passed on. Examples of such diseases are hepatitis and HIV infection. These problems have not been reported to date, however, and are unlikely since the tissue is tested before being used. If you have questions or concerns about this, check with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. The following side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of these effects continue or are bothersome:

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

Revised: 07/17/1996

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