Fabrazyme

 
Generic Name: agalsidase beta

Brands: Fabrazyme

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What is the most important information I should know about Fabrazyme?

· 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 Fabrazyme in many patients. Most patients treated with Fabrazyme develop antibodies to Fabrazyme 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.

 

What is Fabrazyme?

· Fabrazyme 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. Fabrazyme reduces deposits of globotriaosylceramide (GL-3) in the kidneys and other certain other cells in the body.

· Fabrazyme is used in the treatment of Fabry disease.

· Fabrazyme may also be used for purposes other than those listed here.

 

What should I discuss with my health care provider before using Fabrazyme?

· Before using Fabrazyme, tell your doctor if you have     ·had an allergic reaction to Fabrazyme or have antibodies to the medication; or     ·heart problems.

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

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

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

 

How should I use Fabrazyme?

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

· Fabrazyme 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 Fabrazyme to monitor progress and side effects.

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

 

What happens if I miss a dose?

· Contact your doctor if you miss a dose of Fabrazyme.

 

What happens if I overdose?

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

· Although symptoms of an Fabrazyme overdose are not known, an overdose is unlikely to threaten life.

 

What should I avoid while taking Fabrazyme?

· There are no restrictions on food, beverages, or activity during treatment with Fabrazyme.

 

What are the possible side effects of Fabrazyme?

· 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 Fabrazyme in many patients. Most patients treated with Fabrazyme develop antibodies to Fabrazyme 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.

 

What other drugs will affect Fabrazyme?

· Fabrazyme 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 Fabrazyme.

 

Where can I get more information?

· Your pharmacist has more information about Fabrazyme written for health professionals that you may read.

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