Fabrazyme (agalsidase beta) is a man-made form of the naturally-occurring alpha-galactosidase A enzyme. A deficiency of this enzyme is called Fabry disease. Agalsidase beta reduces deposits of globotriaosylceramide (GL-3) in the kidneys and 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.
Important information
Many people have a severe reaction to Fabrazyme. Tell your caregiver right away if you have a side effect such as: 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 feeling light-headed.
Most patients treated with Fabrazyme 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.
Before using Fabrazyme
To make sure Fabrazyme is safe for you, tell your doctor if you have:
FDA pregnancy category B. Fabrazyme is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether agalsidase beta passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
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 Fabrazyme. Taking part in this registry is especially important if you are pregnant or breast-feeding.
How should I use Fabrazyme?
Fabrazyme is injected into a vein through an IV. A healthcare provider will give you this injection.
Fabrazyme is usually given once every 2 weeks. Follow your doctor"s instructions.
While using agalsidase beta, you may need frequent medical tests.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Fabrazyme injection.
What happens if I overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Fabrazyme side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Fabrazyme:
-
skin rash, hives, flushing (warmth, redness, or tingly feeling);
-
trouble swallowing, chest discomfort, difficult breathing, feeling light-headed; or
-
swelling of your face, lips, tongue, or throat.
Many people have a severe reaction to the Fabrazyme infusion (side effects that occur during the injection). Tell your caregiver right away if you have any of these signs of an infusion reaction:
-
fever, headache, chills, stuffy nose, muscle pain, back pain, dizziness, drowsiness, tired feeling;
-
pale skin, feeling hot or cold, itching, numbness or tingly feeling, swelling in your hands or feet;
-
nausea, vomiting, tight feeling in your throat, stomach pain, diarrhea;
-
chest pain, fast or slow heart rate, feeling short of breath; or
-
a light-headed feeling, like you might pass out.
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.
See also: Side effects (in more detail)
What other drugs will affect Fabrazyme?
Other drugs may interact with agalsidase beta, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
