Agalsidase beta

Generic name: agalsidase beta [ a-GAL-si-dase-BAY-ta ]
Brand name: Fabrazyme
Dosage form: intravenous powder for injection (35 mg; 5 mg)
Drug class: Lysosomal enzymes

Medically reviewed by Drugs.com on Apr 1, 2025. Written by Cerner Multum.

What is agalsidase beta?

Agalsidase beta is used in the treatment of Fabry disease in adults and children at least 2 years old.

Agalsidase beta may also be used for purposes not listed in this medication guide.

Agalsidase beta side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Many people have serious or life-threatening reaction to agalsidase beta. Some side effects may occur during or after the injection. Tell your caregiver right away if you have any of these signs of an infusion reaction:

• chest pain, tightness in your throat, fast or slow heartbeats, pounding in your neck or ears;

• shortness of breath, stuffy nose, feeling hot or cold;

• tiredness, drowsiness, dizziness, feeling like you might pass out;

• rash, itching, numbness or tingling;

• nausea, vomiting, stomach pain, diarrhea; or

• muscle pain, swelling in your hands or feet.

Common side effects of agalsidase beta may include:

• headache, fever, chills, cough;

• dizziness;

• swelling in your hands or feet;

• numbness or tingling;

• feeling tired;

• rash; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

Many people have serious or life-threatening reaction to agalsidase beta. Tell your caregiver if you have a skin rash or hives, fever, chills, headache, muscle pain, dizziness, numbness, swelling, vomiting, diarrhea, chest pain, trouble swallowing or breathing, fast or slow heart rate, or severe dizziness.

Before taking this medicine

Tell your doctor if you have or have ever had:

• heart problems; or

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

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of agalsidase beta on the baby.

How is agalsidase beta given?

Agalsidase beta is injected into a vein by a healthcare provider once every 2 weeks.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may need frequent medical tests.

Your name may be listed on a Fabry disease patient registry. This is to track the progress of your disease and to evaluate the treatment effects of agalsidase beta.

Agalsidase beta dosing information

Usual Adult Dose for Fabry Disease:

1 mg/kg via IV infusion every 2 weeks

INFUSION RATE: Initial infusion rate should not exceed 0.25 mg/min (15 mg/hr); once tolerance to the infusion is well established, may increase infusion rate in increments of 0.05 to 0.08 mg/min with each subsequent infusion
Maximum infusion rate (weight less than 30 kg): 0.25 mg/minute
Minimum infusion duration (weight 30 kg or greater): 1.5 hours (based on individual patient tolerability)

Comments:
-Antipyretics are recommended prior to infusions; anti-histamines should also be given in patients who have had an infusion-associated reaction.
-For patients who have had a positive skin test, see dose adjustment section for rechallenge administration.

Use: For treatment of patients with confirmed Fabry disease.

Usual Pediatric Dose for Fabry Disease:

2 years or older:
1 mg/kg via IV infusion every 2 weeks

INFUSION RATE: Initial infusion rate should not exceed 0.25 mg/min (15 mg/hr); once tolerance to the infusion is well established, may increase infusion rate in increments of 0.05 to 0.08 mg/min with each subsequent infusion
Maximum infusion rate (weight less than 30 kg): 0.25 mg/minute
Minimum infusion duration (weight 30 kg or greater): 1.5 hours (based on individual patient tolerability)

Comments:
-Antipyretics are recommended prior to infusions; anti-histamines should also be given in patients who have had an infusion-associated reaction.
-For patients who have had a positive skin test, see dose adjustment section for rechallenge administration.

Use: For treatment of patients 2 years or older with confirmed Fabry disease.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your agalsidase beta injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving agalsidase beta?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect agalsidase beta?

Other drugs may affect agalsidase beta, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Agalsidase beta Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for agalsidase beta.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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