Galafold: Uses, Side Effects and Dosage

What is GALAFOLD?

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.

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 your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take GALAFOLD.

Pregnancy and Breastfeeding Exposure Study. There is a study that collects information on pregnant women with Fabry disease and women with Fabry disease who take GALAFOLD and breastfeed a baby up to 1 year of age. The purpose of this study is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this study.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines or supplements containing caffeine as these medicines or supplements may affect how GALAFOLD works.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take GALAFOLD?

• Read the Instructions for Use at the end of this Patient Information leaflet 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.
• Swallow the GALAFOLD capsule whole. Do not cut, crush, or chew the GALAFOLD capsule.

• Take GALAFOLD on an empty stomach.

• Do not eat food, or take or drink any product that contains caffeine at least 2 hours before and 2 hours after taking GALAFOLD to give a minimum 4 hour fast.
• You may drink water (plain, flavored, or sweetened), fruit juices without pulp, and caffeine-free carbonated beverages during this time when you cannot eat.

• 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 following your original 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.

What are the possible 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.

How should I store GALAFOLD?

• Store GALAFOLD at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep GALAFOLD capsules in the blister card they come in to protect from moisture.

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

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 GALAFOLD to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about GALAFOLD 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.

Manufactured for: Amicus Therapeutics US, LLC, 3675 Market Street, Philadelphia, PA 19104

GALAFOLD is a registered trademark of Amicus Therapeutics, Inc.

For more information, go to www.GALAFOLD.com or call 1-877-426-4287.

INSTRUCTIONS FOR USE

GALAFOLD^® (GAL-a-fold)

(migalastat)

capsules

This Instructions for Use contains information on how to take GALAFOLD. Read this Instructions for Use before you start taking GALAFOLD 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.

Important Information You Need to Know Before Taking GALAFOLD.

• Take 1 GALAFOLD capsule every other day at the same time of day. Do not take GALAFOLD two days in a row.
• Swallow the GALAFOLD capsule whole. Do not cut, crush, or chew the GALAFOLD capsule.
• Take GALAFOLD on an empty stomach.
• Do not eat food, or take or drink any product that contains caffeine at least 2 hours before and 2 hours after taking GALAFOLD to give a minimum 4 hour fast.
• You may drink water (plain, flavored, or sweetened), fruit juices without pulp, and caffeine-free carbonated beverages during this time when you cannot eat.

How to remove a capsule:

Figure A	Step 1. Remove the adhesive seal holding the cover. Lift the cover of your GALAFOLD carton (See Figure A).
Figure B. Opened carton	Step 2. Press and hold down the purple tab with your thumb on the left side of the carton (See Figure B), and continue to Step 3.
Figure C	Step 3. Grasp the tab on the right side of the blister card where it says, “PULL OUT HERE” and pull out the folded blister card (See Figure C).
Figure D. Front of the blister card	Step 4. Unfold the blister card (See Figure D).
Taking GALAFOLD capsules: Each GALAFOLD blister card contains 14 GALAFOLD capsules (enough for 28 days of treatment with GALAFOLD) and 14 white cardboard circles. The white cardboard circles are to remind you to take GALAFOLD every other day. The arrow directs you to begin the next 2 weeks of treatment after Day 14 (See Figure E). Figure E. Front of the blister card
Figure F. Front of the blister card	Step 5. On your first day of taking GALAFOLD from a new blister card, record the date on the blister card next to “Starting date:” (See Figure F).
Figure G. Back of the blister card	Step 6. Locate the GALAFOLD capsule to remove for the dosing day. Turn the blister card over to show the back of the card. Bend the card as shown (See Figure G). Note: Bending the blister card helps raise the oval perforated cardboard.
Figure H. Back of the blister card	Step 7. Remove the oval perforated cardboard (See Figure H). Note: After removing the oval cardboard, the white backing of the foil may be present, which is ok.
Figure I. Front of the blister card	Step 8. Turn the blister card over to show the front of the card. Push the GALAFOLD capsule out (See Figure I).
Figure J. Front of the blister card	Step 9. On the next day, move to the perforated white cardboard circle on the top row. Press down on the white cardboard circle to remove it (See Figure J). Note: Removing this white cardboard circle will help you remember which day you do not take GALAFOLD. Take 1 GALAFOLD capsule every other day. Fold the blister card, and slide it back into the carton after each use.
Change (alternate) each day between taking the GALAFOLD capsule and removing the perforated white cardboard circle until you reach Day 28. Start a new blister card when you are finished with Day 28.

How should I store GALAFOLD?

• Store GALAFOLD at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep GALAFOLD capsules in the blister card they come in to protect from moisture.

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

Manufactured for:

Amicus Therapeutics US, LLC

3675 Market Street

Philadelphia, PA 19104

GALAFOLD is a registered trademark of Amicus Therapeutics, Inc.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: June 2023