Galafold

Galafold is a prescription medication used to treat adults with Fabry disease with a confirmed diagnosis and specific mutation of the galactosidase alpha gene. Galafold belongs to a group of drugs called pharmacologic chaperones. These medications work by stabilizing the defective enzyme and increasing the activity of it.

This medication comes in capsule form and is taken every other day on an empty stomach. Do not eat at least 2 hours before and 2 hours after taking Galafold. Do not chew, divide, or break Galafold capsule. Swallow capsules whole.

Common side effects of Galafold include headache, stuffy or runny nose, urinary tract infection, and nausea.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Galafold. See the Galafold Precautions" section.

Common side effects of Galafold include the following:

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

This is not a complete list of Galafold side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effects that bother you or that do not go away. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been Galafold by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Galafold is not recommended for use in patients with severe kidney impairment or end-stage kidney disease requiring dialysis.

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

Before taking Galafold tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Galafold or to any of its ingredients
• have kidney disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Galafold will harm your unborn baby.

In clinical trials, there were three pregnant women with Fabry disease and exposed to Galafold. The available data from these trials were not sufficient to assess drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 

In animal reproduction studies, no adverse developmental effects were observed. 

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Galafold crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Galafold. 

• Read the Instructions for Use that comes with your medication for detailed instructions about the right way to take Galafold.
• Take 1 Galafold 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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The recommended dosage regimen of Galafold is 123 mg orally once every other day at the same time of day.

If you take too much Galafold, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Galafold at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Galafold capsules in the blister card that they come in.

Keep Galafold and all medicines out of the reach of children.