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Generic Name: Agalsidase beta [a-GAL-sih-daze-bay-tah ].
Drug Class: Lysosomal enzymes.

What is Fabrazyme?

Fabrazyme is a human-made version of the naturally occurring alpha-galactosidase enzyme. The absence of this enzyme is known as Fabry disease. Agalsidase beta lowers globotriaosylceramide (GL-3) deposits in the kidneys and other bodily cells. Fabrazyme is used for treating Fabry disorder (a deficiency of the alpha-galactosidase A enzyme) in children and adults aged 2 or more years. Fabrazyme can be used for other reasons that are not listed here.


Many suffer from an extremely severe response to Fabrazyme. Contact your physician when you experience an itch or skin rash, chills, fever, headache, or if you experience dizziness, muscle pain, nausea, numbness, chest pain, diarrhea, breathing difficulties, difficulty breathing or swallowing, a rapid as well as a slow rate of heartbeat, or excessive dizziness. Patients who are treated by Fabrazyme develop antibodies against Agalsidase Beta, and a large number suffer from signs of an infusion-related reaction. The slow rate of administration of the medication as well as the pretreatment of other medications can reduce the severity of symptoms. Medical emergency treatment is required in the event of an extreme allergic reaction.

Before you take this drug

To be sure Fabrazyme is suitable for you, inform your doctor if you've previously had:

  • Heart issues.
  • An allergy to agalsidase beta or antibodies to the drug.

If you are breastfeeding or pregnant, speak with your doctor. Your name might be listed on the Fabry patient registry. This will help track the progression of your condition and also determine the effects of treatment with Fabrazyme. Participating in this registry is crucial if you're pregnant or nursing.

How to take Fabrazyme?

Fabrazyme is administered as an infusion into the vein. Your healthcare professional will give the injection. Fabrazyme is typically given every two weeks. Follow the instructions of your physician. Doses are determined by weight. If you gain or lose weight, your dose may change. If you're using agalsidase beta, you may require regular medical tests.

Details on dosage

Usual Adult Dose for Fabry Disease:

1 mg/kg IV every two weeks
Comments: Initial infusion rates must be less than 0.25 mg/min (15 mg/hr).
The clinical studies did not contain enough patients 65 years of age or older to know the extent to which they react differently from younger patients.
Use: To treat patients suffering from Fabry disease.

Usual Pediatric Dose for Fabry Disease:

8 years and older 1 mg/kg IV once every 2 weeks
Comments: The initial infusion rate must be less than 0.25 mg/min (15 mg/hr).
Use: To treat patients suffering from Fabry disease.

What happens if I miss a dose?

Consult your physician for the proper treatment in the event that you don't make an appointment to receive a Fabrazyme injection.

What happens if I overdose?

Because this medication is administered by a health specialist in a medical setting, any overdose could be dealt with promptly.

What should be avoided?

Follow the instructions of your physician regarding any limitations on foods, drinks, or any activity.

Side effects of Fabrazyme

Take immediate medical care. If you show symptoms that you are experiencing an allergic reaction to Fabrazyme:

  • Coughing, chest tightness, difficult breathing, feeling lightheaded.
  • Skin rash and hives flushing (warmth, redness or tingly sensation).
  • Difficulty swallowing.
  • Swelling of your lips, tongue, or face.

Certain side effects can occur during an injection. Contact your physician immediately if you notice any of the following symptoms of an adverse reaction:

  • Chest discomfort, tightness in the throat, rapid or slow heartbeats, pounding your neck or ear canals.
  • Breathing, a dry nose Feeling hot or cold.
  • Tiredness, drowsiness, dizziness, and the sensation of passing out.
  • Numbness, itching, rash, or tingling.
  • Nausea, vomiting, stomach pain, diarrhea.
  • Muscle pain, headaches, and swelling in your feet or hands.

Common Fabrazyme side effects can be:

  • Fever, chills, cough.
  • Dizziness.
  • Swelling of your feet or hands.
  • Numbness or tingling.
  • Fatigue.
  • The rash.
  • Symptoms like nasal stuffiness, sneezing, and a sore throat.

This isn't an exhaustive list of all the side effects. Other side effects could occur. Consult your physician for advice regarding medical adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with other drugs

Other medications can interfere with agalsidase beta, which includes prescription and over-the-counter medicines, vitamins, and herbal products. Discuss with your physician your current medications as well as any medications you are about to start or stop taking.