Fabrazyme

DRUG DESCRIPTION

Fabrazyme® (agalsidase beta) is a recombinant human ?-galactosidase A enzyme with the same amino acid sequence as the native enzyme. Purified agalsidase beta is a homodimeric glycoprotein with a molecular weight of approximately 100 kD. The mature protein is comprised of two subunits of 398 amino acids (approximately 51 kD), each of which contains three N-linked glycosylation sites. ?-galactosidase A catalyzes the hydrolysis of globotriaosylceramide (GL-3) and other ?-galactyl-terminated neutral glycosphingolipids, such as galabiosylceramide and blood group B substances to ceramide dihexoside and galactose. The specific activity of Fabrazyme (agalsidase beta) is approximately 70 U/mg (one unit is defined as the amount of activity that results in the hydrolysis of 1 rjmoie of a synthetic substrate, p-nitrophenyl-?-D-galactopyranoside, per minute under the assay conditions).

Fabrazyme (agalsidase beta) is produced by recombinant DNA technology in a Chinese Hamster Ovary mammalian cell expression system.

Fabrazyme (agalsidase beta) is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for reconstitution with Sterile Water for Injection, uSp. Each 35 mg vial contains 37 mg of agalsidase beta as well as 222 mg mannitol, 20.4 mg sodium phosphate monobasic monohydrate, and 59.2 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 35 mg of agalsidase beta (7 mL) may be extracted from each 35 mg vial.

Each 5 mg vial contains 5.5 mg of agalsidase beta as well as 33.0 mg mannitol, 3.0 mg sodium phosphate monobasic monohydrate, and 8.8 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 5 mg of agalsidase beta (1 mL) may be extracted from each 5 mg vial.

What are the possible side effects of agalsidase beta (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 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...

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Fabrazyme Patient Information Including Side Effects

Brand Names: Fabrazyme

Generic Name: agalsidase beta (Pronunciation: a GAL sih daze BAY tah)

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

What is agalsidase beta (Fabrazyme)?

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.

What are the possible side effects of agalsidase beta (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 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.

What is the most important information I should know about agalsidase beta (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 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.

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