Pregnancy & Lactation: Risk data not available
What is Cipaglucosidase Alfa?
Cipaglucosidase alfa is used in combination with Opfolda (miglustat) to treat late-onset Pompe disease in adults who weigh at least 88 pounds (40 kg), and when enzyme replacement therapy did not work or stopped working.
Cipaglucosidase alfa may also be used for purposes not listed in this medication guide.
Warnings
Tell your doctor if you have or have ever had:
- fluid retention;
- heart problems; or
- lung disease or breathing problems.
People with severe heart or respiratory problems or prone to fluid retention may have a higher risk of their condition worsening. Talk to your doctor about your risk.
May harm an unborn baby. Do not use if you are pregnant. You will need to have a negative pregnancy test before starting this treatment. Use effective birth control while receiving this treatment and for at least 60 days after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while receiving this medicine.
When used together with Opfolda (miglustat), cipaglucosidase alfa may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.
How should I use Cipaglucosidase Alfa
Use Cipaglucosidase Alfa (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Cipaglucosidase alfa must be administered together with Opfolda (miglustat).
Your doctor will stop your other treatments for Pompe disease before your first dose of cipaglucosidase alfa. Follow your doctor's dosing instructions very carefully.
Make sure you take Opfolda (miglustat) 1 hour before receiving cipaglucosidase alfa.
You will receive cipaglucosidase alfa as an infusion into a vein about 1 hour after you take Opfolda (miglustat). A healthcare provider will give you this injection every other week.
Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely to make sure you do not have serious side effects.
You may be given other medications to help prevent or treat serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
Doses are based on weight. Your dose may change if you gain or lose weight.
You must take Opfolda (miglustat) before receiving cipaglucosidase alfa injection. Call your doctor for instructions if you skip an Opfolda dose or miss an appointment for the injection.
Cipaglucosidase Alfa side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some people have a severe reaction to cipaglucosidase alfa. These side effects may occur during or within a few hours after the injection. Tell your medical caregiver if you feel dizzy, nauseated, itchy, sweaty, light-headed, have a headache, chest pain or tightness, back pain, chills, swelling, or trouble breathing.
Also tell your medical caregivers right away if you have:
- slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).
Common side effects may include:
- headache, weak or tired feeling;
- diarrhea, nausea, stomach pain; or
- fever.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Cipaglucosidase Alfa?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.