Galafold (migalastat)

Galafold is a prescription medicine used to treat adults with Fabry disease who have a certain genetic change (variant) in the galactosidase alpha gene (GLA) that is responsive (amenable) to Galafold.

It is not known if Galafold is safe and effective in children.

The most common side effects of Galafold include:

• headache
• stuffy or runny nose and sore throat
• urinary tract infection
• nausea
• fever

These are not all the possible side effects of Galafold. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088. You may also report side effects to Amicus Therapeutics at 1-877-426-4287.

• The recommended dosage regimen of Galafold is 123 mg orally once every other day at the same time of day.
• Take Galafold on an empty stomach. Do not consume food at least 2 hours before and 2 hours after taking Galafold to give a minimum 4 hours fast. Clear liquids can be consumed during this 4-hour period.
• Do not take Galafold on 2 consecutive days.
• If a dose is missed entirely for the day, take the missed dose of Galafold only if it is within 12 hours of the normal time that the dose should have been taken. If more than 12 hours have passed, resume taking Galafold at the next planned dosing day and time, according to the every-other-day dosing schedule.
• Swallow capsules whole. Do not cut, crush, or chew.

No Information Provided

• The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
• There is a registry that monitors outcomes in individuals with Fabry disease, either exposed or unexposed to Galafold during pregnancy and/or while breastfeeding infants up to 1 year of age.
• Healthcare providers are encouraged to register patients or obtain additional information by contacting the Pregnancy Coordinating Center at 1-888-239-0758, email at [email protected], or visit www.fabrypregnancyregistry.com.
• There are no human data available on the presence of migalastat in human milk, the effects on the breastfed infant, or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition.