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sebelipase alfa

Generic Name: sebelipase alfa (SE be LYE pase AL fa)
Brand Name: Kanuma

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.

What is the most important information I should know about sebelipase alfa?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before receiving sebelipase alfa?

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 is sebelipase alfa given?

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.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your sebelipase alfa injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving sebelipase alfa?

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

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.

See also: Side effects (in more detail)

Sebelipase alfa dosing information

Usual Adult Dose for Wolman's Disease:

1 mg/kg IV every other week

Use: For the treatment of lysosomal acid lipase (LAL) deficiency

Usual Pediatric Dose for Wolman's Disease:

1 month or older:
1 mg/kg IV every other week

Rapidly progressive LAL deficiency presenting within first 6 months of life:
-Initial dose: 1 mg/kg IV once a week
-Maintenance dose: May increase to 3 mg/kg IV once a week if optimal clinical response is not achieved

Use: For the treatment of LAL deficiency

What other drugs will affect sebelipase alfa?

Other drugs may interact with sebelipase alfa, 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.

Where can I get more information?

  • Your pharmacist can provide more information about sebelipase alfa.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.02.

Date modified: November 30, 2016
Last reviewed: June 24, 2016

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