Olipudase Alfa-rpcp (oh-LIP-ue-dase AL-fa - rpcp)

Treats acid sphingomyelinase deficiency (ASMD).

Brand Name(s):

Xenpozyme

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so the needle will have to stay in place for at least 20 minutes.
• A nurse or other health provider will give you this medicine.
• You may also receive medicines (including allergy medicine, fever medicine, steroids) to help prevent possible unwanted effects during the injection.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment with this medicine and for at least 14 days after the last dose.
• Tell your doctor if you are breastfeeding.
• This medicine may cause infusion-related reactions.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lightheadedness or fainting
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, stomach pain
• Headache
• Joint pain
• Redness of the eye
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088