Generic Name: migalastat
Dosage Form: Capsules
Date of Approval: August 10, 2018
Company: Amicus Therapeutics
Treatment for: Fabry Disease
Medically reviewed on August 20, 2018
FDA Approves Galafold
The U.S. Food and Drug Administration (FDA) has granted accelerated approval of Galafold (migalastat), an oral, precision medicine for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant.
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is Galafold?
Galafold is a prescription medicine used to treat adults with Fabry disease who have a certain genetic change (variant) in an enzyme called alpha galactosidase A (GLA) that is responsive (amenable) to Galafold.
It is not known if Galafold is safe and effective in children.
Before taking Galafold
Before taking Galafold, tell your healthcare provider about all of your medical conditions, including if you:
- have kidney problems.
- are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
- are breastfeeding or plan to breastfeed. This medicine may pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Galafold.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take Galafold?
- Read the Instructions for Use that supplied with your prescription for detailed instructions about the right way to take Galafold.
- Take one Galafold capsule every other day at the same time of day.
- Do not take Galafold two days in a row.
- Take the capsules on an empty stomach. Do not eat at least two hours before and two hours after taking a dose. You may drink clear liquids during this 4 hour time when you cannot eat.
- Swallow the capsule whole. Do not cut, crush, or chew the Galafold capsule.
- If you miss a dose, take the missed dose within 12 hours of your normal schedule. If more than 12 hours have passed, do not make up the missed dose. Take your next dose of Galafold at your next scheduled day and time according to your every-other-day dosing schedule.
For example, if you miss a dose that you would normally take at 8:00 AM, then you should take that dose before 8:00 PM on the same day. If you do not take the missed dose before 8:00 PM on the same day, you should take your next dose at 8:00 AM on your next scheduled dosing day.
Galafold side effects
The most common side effects of Galafold include:
- stuffy or runny nose and sore throat
- urinary tract infection
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Galafold?
- Store Galafold capsules at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep the capsules in the blister card that they come in.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Galafold.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Galafold for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have as it may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients in Galafold?
Active ingredient: migalastat hydrochloride
Inactive ingredients: magnesium stearate and pregelatinized starch.
Capsule shells contain gelatin, indigotine-FD&C Blue 2, and titanium dioxide. The black ink contains black iron oxide, potassium hydroxide, and shellac.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.