DrugindexOnline^{2nd edition}

Some commonly used brand names are:

In the U.S.—

• Fabrazyme

† Not commercially available in Canada.

Category

• Enzyme (alpha-galactosidase A) replenisher

Description

Agalsidase beta (a-GAl-si-daze bay-ta) is used to treat Fabry disease which is an inherited disease caused by the lack of an enzyme called alpha-galactosidase A, in the body. This enzyme is necessary for your body.

Agalsidase beta is available only with your doctor's prescription, in the following dosage forms:

• Parenteral
• Injection (U.S.)

Before Using 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 agalsidase beta, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to agalsidase beta. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Agalsidase beta has not been studied in pregnant women or animals.

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

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of agalsidase beta in children with use in other age groups.

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 agalsidase beta 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]) medicine.

Other medical problems—The presence of other medical problems may affect the use of agalsidase beta. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart problems—May be at a higher risk of severe complications from infusion reaction.

Proper Use of This Medicine

Dosing—The dose of agalsidase beta will be different for different patients. Follow your doctor's orders . The following information includes only the average doses of agalsidase beta.

• For Fabry disease:
  • For injection dosage form:
    • Adults—The dose is based on body weight and must be determined by your doctor. The usual dose is 1 mg per kilogram (kg) of body weight, injected slowly into a vein. The dose may be repeated once every 2 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—Contact your doctor as soon as possible for instructions.

Precautions While Using This Medicine

It is important that your doctor monitor your progress while you are receiving agalsidase beta to make sure that the medicine is working properly.

It is important to take medicine for treatment of infusion reaction prior to receiving your infusion.

Importance of receiving agalsidase beta in health care facility with medical support for severe infusion reactions.

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.

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

Developed: 03/29/2004

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