Cipaglucosidase Alfa-atga (sip-a-gloo-KOE-si-dase AL-fa - atga)

Treats Pompe disease.

Brand Name(s):

Pombiliti

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. It must be given slowly, so the needle will have to remain in place for 4 hours.
• A nurse or other health provider will give you this medicine.
• Your doctor will give you other medicines (including allergy, fever, or steroid medicine) before you receive this medicine to help prevent unwanted effects.
• 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 woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment and for at least 60 days after the last dose.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have heart disease or lung disease.
• This medicine may cause infusion-related reactions, which can be life-threatening and require medical attention.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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
• Blurred vision, headache, pounding in the ears, slow or fast heartbeat
• Chest pain, trouble breathing, cold sweats, blue lips, fingernails, or skin
• Lightheadedness, dizziness, fainting
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Swelling in your hands, ankles, or feet

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

• Diarrhea, nausea, stomach pain
• Fever
• 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