cipaglucosidase alfa-atga 105 mg intravenous solution

Generic name:
Cipaglucosidase alfa - injection

Pronunciation
(SIP-a-gloo-KOE-si-dase Al-fa)

Brand name(s)
Pombiliti

Infusion reactions or serious (sometimes fatal) allergic reactions may happen during the infusion of cipaglucosidase alfa and for a short time afterward. Your doctor may prescribe other medications (such as a fever reducer, antihistamines, corticosteroids) before each treatment to help prevent these side effects. Get medical help right away if you have any symptoms of a serious allergic reaction or infusion reactions such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chills, or flushing. Your doctor may slow down or stop your treatment for some time.

Before starting treatment with this medication, tell your doctor if you have a history of heart problems (such as heart failure), breathing problems (such as fluid in the lungs), or swelling. These problems may get worse during the infusion. Your doctor or nurse may monitor you for longer periods after your infusion.

Cipaglucosidase alfa is used in combination with another medication (miglustat) to treat a certain inherited condition (Pompe disease). It works by breaking down a certain substance (glycogen) that builds up in the body due to this condition. Decreasing glycogen in the body can help improve symptoms of Pompe disease such as muscle weakness, heart problems, and breathing problems.

This medication must be used with miglustat because it helps cipaglucosidase alfa stay active in the blood which helps it work better.

See also Warning section.

This medication is given as directed by your doctor, usually once every other week, 1 hour after you take miglustat. It is injected slowly into a vein, usually over 4 hours, by a health care professional.

The dosage is based on your medical condition, 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. If you miss your dose of miglustat or your infusion is not started within 3 hours of taking miglustat, your infusion will need to be rescheduled. Ask your doctor or pharmacist right away for a new dosing schedule.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Headache, diarrhea, or dizziness 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.

See also Warning section.

Before using cipaglucosidase alfa, tell your doctor or pharmacist if you are allergic to it; 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 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).

When used in combination with miglustat, this medication must not be used during pregnancy. It may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Discuss the use of reliable forms of birth control while using this medication and for at least 60 days after the last dose. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. 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.

Keep all medical and lab appointments.

See also How to Use section.

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 or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.