GALAFOLD™ | Information for Patients and Families
Galafold

Now Approved

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.

Talk with your doctor if you have any questions or would like more information about using 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 Galafold will harm your unborn baby
  • are breastfeeding or plan to breastfeed. Galafold 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.

  • Take 1 GALAFOLD 123 mg capsule every other day at the same time of day.
  • Do not take GALAFOLD two days in a row.
  • Take GALAFOLD on an empty stomach. Do not eat at least 2 hours before and 2 hours after taking GALAFOLD. You may drink clear liquids during this 4 hour time when you cannot eat.
  • Swallow GALAFOLD capsule whole. Do not cut, crush, or chew the GALAFOLD capsule.
  • If you miss a dose of GALAFOLD, take the missed dose of GALAFOLD 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.

The most common side effects of Galafold include:

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

These are not all the possible side effects of Galafold. Call your healthcare provider 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 1-877-4AMICUS.

Amicus assist is a free service for patients and families designed to provide assistance and support to help with access to Galafold.

To learn more about how Amicus assist works and ways it can assist you, click here.

We will continue to update this website as more information about Galafold™ (migalastat) becomes available. Sign up to receive email updates to be notified when something new is added.

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You are encouraged to report negative side effects of prescriptions drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATION

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.

IMPORTANT SAFETY INFORMATION

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 Galafold will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Galafold 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.

What are the possible side effects of Galafold?

The most common side effects of Galafold were headache, stuffy or runny nose and sore throat, urinary tract infection, nausea, and fever.

These are not all the possible side effects of Galafold. Call your healthcare provider 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 1-877-4AMICUS.

Please click here for the Full Prescribing Information including Patient Information and Instructions for Use.