Migalastat (Oral Route)

Migalastat is used to treat adults with Fabry disease who have a certain genetic change (variant) in an enzyme called galactosidase alpha (GLA). Your doctor will test for this GLA gene variant.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Capsule

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of migalastat in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of migalastat in the elderly.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is 12 hours or less from your normal dosing schedule, take the missed dose as soon as possible. If you miss a dose and it is more than 12 hours from your regular dosing schedule, skip the missed dose and take your next dose at the regular time.