Pregnancy & Lactation: Risk data not available
What is Sebelipase Alfa?
Sebelipase alfa is a copy of an enzyme that is normally produced in the body to help break down fats and keep them from building up in your cells.
Sebelipase alfa is used to treat lysosomal acid lipase deficiency. This is a life-threatening genetic disorder that can damage major organs in the body and lead to early death. Sebelipase alfa replaces the missing enzyme when the body does not have enough of its own.
Sebelipase alfa may also be used for purposes not listed in this medication guide.
Warnings
You should not be treated with sebelipase alfa if you are allergic to it.
To make sure sebelipase alfa is safe for you, tell your doctor if you have:
- an allergy to eggs or egg products.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether sebelipase alfa passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Sebelipase alfa is not approved for use by anyone younger than 1 month old.
How should I use Sebelipase Alfa
Use Sebelipase Alfa (Intravenous) 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.
Sebelipase alfa is injected into a vein through an IV. A healthcare provider will give you this injection.
Sebelipase alfa is usually given once every other week. The IV infusion must be given slowly and can take 1 to 2 hours to complete.
You will be watched closely during and after receiving sebelipase alfa, to make sure you do not have an allergic reaction to the medication.
Tell your doctor if you have any changes in weight. Sebelipase alfa doses are based on weight (especially in children), and any changes may affect the dose.
Call your doctor for instructions if you miss an appointment for your sebelipase alfa injection.
Sebelipase Alfa 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.
Some side effects may occur during the injection. Tell your caregiver right away if you feel itchy, flushed, chilled or feverish, or if you have a runny nose, eye irritation, diarrhea, chest discomfort, or trouble breathing.
Call your doctor at once if you have:
- severe skin rash, itching, or swelling;
- agitation, irritability;
- stomach pain; or
- low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.
Common side effects may include:
- fever, weakness;
- runny nose, sinus pain, sore throat, cough;
- rash;
- diarrhea, constipation;
- nausea, vomiting; or
- headache.
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 Sebelipase Alfa?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.