Agalsidase beta is a man-made form of the naturally-occurring enzyme a-galactosidase A. A deficiency of the enzyme a-galactosidase A is called Fabry disease. Agalsidase beta reduces deposits of globotriaosylceramide (GL-3) in the kidneys and other certain other cells in the body.

Agalsidase beta is used in the treatment of Fabry disease.

Agalsidase beta may also be used for purposes other than those listed here.

Symptoms of allergic or infusion reactions including difficulty breathing; closing of the throat; hives; rash; itching; fever; shaking; chest tightness; high or low blood pressure; fast heartbeats; muscle pain; stomach pain; nausea or vomiting; dizziness; numbness or tingling; and headache have occurred upon injection of agalsidase beta in many patients. Most patients treated with agalsidase beta develop antibodies to agalsidase beta and many will develop symptoms of an infusion reaction. A slow rate of injection of the medication and pretreatment with other medications may decrease the severity of these symptoms. Emergency medical attention may be required if a severe allergic reaction is experienced.

Before using agalsidase beta, tell your doctor if you have

• had an allergic reaction to agalsidase beta or have antibodies to the medication; or

• heart problems.

You may not be able to use agalsidase beta, or you may require a dosage adjustment or special monitoring during treatment.

Agalsidase beta is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use agalsidase beta without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether agalsidase beta passes into breast milk. Do not use agalsidase beta without first talking to your doctor if you are breast-feeding a baby.