What the FDA labels say about taking them together
Cipaglucosidase alfa and miglustat
Cipaglucosidase alfa's FDA label of August 12, 2026 names miglustat in its contraindications section, and miglustat's label names cipaglucosidase alfa too. The cipaglucosidase alfa label: “CONTRAINDICATIONS POMBILITI in combination with Opfolda is contraindicated in pregnancy.”
Check it at the source: the cipaglucosidase alfa FDA label on DailyMed (effective August 12, 2026); the miglustat FDA label on DailyMed (effective April 20, 2023, Actelion Pharmaceuticals US, Inc.).
What does the cipaglucosidase alfa label say about miglustat?
Cipaglucosidase alfa label, contraindicationsCONTRAINDICATIONS POMBILITI in combination with Opfolda is contraindicated in pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ].
Cipaglucosidase alfa label, warnings and precautionsAdvise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for at least 60 days after the last dose. ( 4 , 5.4 , 8.1 , 8.3 ) Risks Associated with Opfolda:
Source: FDA drug label (POMBILITI ATGA), AMICUS THERAPEUTICS US, LLC, effective August 12, 2026 (SPL set d77aa596-910d-516b-e053-2995a90a0839), via openFDA; the full label on DailyMed
What does the miglustat label say about cipaglucosidase alfa?
Opfolda label (AMICUS THERAPEUTICS US, LLC, November 27, 2024), contraindicationsCONTRAINDICATIONS OPFOLDA in combination with Pombiliti is contraindicated in Pregnancy [see Use in Specific Populations (8.1 )] Pregnancy.
Opfolda label (AMICUS THERAPEUTICS US, LLC, November 27, 2024), warnings and precautionsAdvise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for at least 60 days after the last dose. ( 4, 5.1, 8.1, 8.3 ) Risks Associated with Pombiliti:
Source: FDA drug label (Opfolda, NDA215211), AMICUS THERAPEUTICS US, LLC, effective November 27, 2024 (SPL set d7c38298-37db-5a80-e053-2995a90aee40), via openFDA
Source: FDA drug label (Zavesca), Actelion Pharmaceuticals US, Inc., effective April 20, 2023 (SPL set 817892d1-ee12-4632-85fc-57ccdf16d7b8), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Cipaglucosidase alfa | Miglustat | |
|---|---|---|
| Labeled for | n/a | n/a |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | n/a | n/a |
| Shortage now | No current entry | No current entry |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once