Miglustat (Opfolda) (Oral)
Opfolda is used in combination with Pombiliti (cipaglucosidase alfa) 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.
This medication guide is specific to the Opfolda brand of miglustat. This brand is not to be used to treat Gaucher disease.
Opfolda may also be used for purposes not listed in this medication guide.
uses
What is Miglustat (Opfolda) (Oral) used for?
- Gaucher Disease
warnings
What is the most important information I should know about Miglustat (Opfolda) (Oral)?
Tell your doctor if you have or have ever had:
- kidney disease.
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 taking Opfolda and for at least 60 days after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using this medicine.
Opfolda may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.
Side Effects
What are the side effects of Miglustat (Opfolda) (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Common side effects may include:
- fever, headache;
- diarrhea, nausea, stomach pain; or
- tiredness.
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.
Pregnancy & Breastfeeding
Can I take Miglustat (Opfolda) (Oral) if I’m pregnant or breastfeeding?
Do not breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Miglustat (Opfolda) (Oral)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Miglustat (Opfolda) (Oral)?
Use Miglustat (Opfolda) (Oral) 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. Opfolda must be administered together with Pombiliti (cipaglucosidase alfa). Use the medicine exactly as directed.
Your doctor will stop your other treatments for Pompe disease before your first dose of Opfolda. Follow your doctor's dosing instructions very carefully.
Opfolda is taken every other week, about 1 hour before you receive the Pombiliti (cipaglucosidase alfa) infusion.
Swallow the capsule whole and drink it only with an unsweetened drink, such as water, tea, or coffee, without cream, sugar, or sweeteners.
Do not eat or drink anything else for at least 2 hours before and 2 hours after taking Opfolda.
Doses are based on weight. Your dose may change if you gain or lose weight.
Your kidney function may need to be checked often.
Store in the original container at room temperature away from moisture, heat, and light.
Call your doctor for instructions if you miss a dose. Your Pombiliti (cipaglucosidase alfa) infusion will need to be rescheduled.
Overdose Signs
What happens if I overdose on Miglustat (Opfolda) (Oral)?
Images
310, AMG
Color: white
Shape: capsule
Imprint: 310, AMG
709
Color: white
Shape: capsule
Imprint: 709
OGT 918, 100
Color: white
Shape: capsule
Imprint: OGT 918, 100