Human medicines European public assessment report (EPAR): Pombiliti, cipaglucosidase alfa, Glycogen Storage Disease Type II, Date of authorisation: 20/03/2023, Status: Authorised
The most common side effects with Pombiliti (which may affect up to 1 in 10 people) are chills, dizziness, flushing, sleepiness, chest discomfort, cough, swelling at the infusion site and pain.
Serious side effects (which may affect up to 1 in 50 people) are itchy rash, serious allergic reactions, fever, feeling faint, difficulty breathing, swelling in the throat, wheezing and low blood pressure.
Pombiliti must not be used in people who have had life-threatening allergic reactions to the active substance or to any of the other ingredients of the medicine. It must also not be used in people who cannot have miglustat.
For the full list of side effects and restrictions, see the package leaflet.
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