Uses
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.
How to use Pombiliti 105 Mg Intravenous Solution Metabolic Disease Enzyme Replacement, Pompe
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 the days on the calendar when you need to receive the medication. 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.
Side Effects
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.
Warnings
Infusion reactions or serious (sometimes fatal) allergic reactions may happen while you are receiving cipaglucosidase alfa and for a short time after. Your doctor may prescribe other medications (such as a fever reducer, antihistamines, corticosteroids) for you to take to help decrease these side effects. Carefully follow your doctor's directions for all of your medications. Get medical help right away if you notice any signs of a serious allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chills, or flushing. Your infusion may be slowed down or stopped depending on your symptoms.
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.
Precautions
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.
Interactions
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.
Overdose
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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
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.
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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.