This medication is used to treat a certain rare genetic problem (lysosomal acid lipase deficiency LAL-D). Sebelipase alfa replaces a certain natural substance (an enzyme called lysosomal acid lipase) that is missing in people with LAL-D. This helps the body to breakdown fats. High fat levels can lead to liver damage or high blood cholesterol levels.

Read the Patient Information Leaflet if available from your pharmacist before you start using sebelipase alfa and each time you get an infusion. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually once every week or once every other week. The injection is given by a health care professional, usually over 2 hours. The dosage is based on your medical condition, age, weight, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition gets worse.

See also Warning section.

Headache, dizziness, or cold symptoms (such as runny/stuffy nose, cough, sneezing) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using sebelipase alfa, tell your doctor or pharmacist if you are allergic to it; or to egg products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may rarely make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as cholesterol/triglyceride levels, liver function, height, weight) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.