agalsidase beta

	What is the most important information I should know about agalsidase beta?
	What is agalsidase beta?
	What should I discuss with my health care provider before using agalsidase beta?
	How should I use agalsidase beta?
	What happens if I miss a dose?
	What happens if I overdose?
	What should I avoid while taking agalsidase beta?
	What are the possible side effects of agalsidase beta?
	What other drugs will affect agalsidase beta?
	Where can I get more information?
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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.

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.

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.

Use agalsidase beta exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Agalsidase beta is given by intravenous (into the vein) injection and will most likely be administered by a healthcare provider.

Your doctor may want you to have blood tests or other medical evaluations during treatment with agalsidase beta to monitor progress and side effects.

Your healthcare provider will store agalsidase beta as instructed by the manufacturer. If you are storing agalsidase beta at home, your healthcare provider will give you instructions regarding how to store the medication.

Contact your doctor if you miss a dose of agalsidase beta.

Contact your doctor, a hospital emergency room, or a poison control center if an overdose is suspected.

Although symptoms of an agalsidase beta overdose are not known, an overdose is unlikely to threaten life.

There are no restrictions on food, beverages, or activity during treatment with agalsidase beta.

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.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Agalsidase beta is not known to interact with other medications. Talk to your doctor or pharmacist before taking other prescription or over-the-counter medications, including herbal products, during treatment with agalsidase beta.

Your pharmacist has more information about agalsidase beta written for health professionals that you may read.