What is the most important information I should know about agalsidase beta?
Many people have a severe 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.
What is agalsidase beta?
Agalsidase beta is used in the treatment of Fabry disease (a deficiency of alpha-galactosidase A enzyme) in adults and children at least 2 years old.
Agalsidase beta may also be used for purposes other than those listed here.
What should I discuss with my healthcare provider before receiving agalsidase beta?
Tell your doctor if you 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.
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. Taking part in this registry is especially important if you are pregnant or breast-feeding.
How should I use agalsidase beta?
Agalsidase beta is injected into a vein by a healthcare provider, usually given 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.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your injection.
What should I avoid while receiving agalsidase beta?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of agalsidase beta?
Get emergency medical help if you have signs of an allergic reaction:
- wheezing, chest tightness, trouble breathing, feeling light-headed;
- skin rash, hives, flushing (warmth, redness, or tingly feeling);
- trouble swallowing; or
- swelling of your face, lips, tongue, or throat.
Some side effects may occur during 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
- headache, muscle pain, swelling in your hands or feet.
Common side effects may include:
- fever, chills, cough;
- 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.
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.
Where can I get more information?
Your doctor or pharmacist can provide more information about agalsidase beta.
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.
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