Fabrazyme (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.
warnings
What is the most important information I should know about Fabrazyme (Agalsidase Beta)?
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.
Side Effects
What are the side effects of Fabrazyme (Agalsidase Beta)?
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 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.
Pregnancy & Breastfeeding
Can I take Fabrazyme (Agalsidase Beta) if I’m pregnant or breastfeeding?
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.
Interactions
What drugs and food should I avoid while taking Fabrazyme (Agalsidase Beta)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Fabrazyme (Agalsidase Beta)?
Use Fabrazyme (Agalsidase Beta) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
Call your doctor for instructions if you miss an appointment for your agalsidase beta injection.
Overdose Signs
What happens if I overdose on Fabrazyme (Agalsidase Beta)?
In a medical setting an overdose would be treated quickly.