What is Fabrazyme?

Agalsidase beta 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.

The dose of this medicine 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 this medicine. 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 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.

Call your doctor or pharmacist for instructions.

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 this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

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.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. 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.

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.