What is Galafold and how does it work?
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.
What are the side effects of Galafold?
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.
What is the dosage for Galafold?
- 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.
What drugs interact with Galafold?
No Information Provided
Is Galafold safe to take when pregnant or breastfeeding?
- 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.