Migalastat (mi-GAL-a-stat)

Treats Fabry disease.

Brand Name(s):

Galafold

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. Do not take this medicine 2 days in a row.
• Swallow the capsule whole. Do not cut, crush, or chew it.
• It is best to take this medicine on an empty stomach.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is 12 hours or lessfrom your normal dosing schedule, take the missed dose as soon as possible. If you miss a dose and it is more than 12 hours from your regular dosing schedule, skip the missed dose and take your next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not eat food or drink any product that contains caffeine at least 2 hours before and 2 hours after (total of at least 4 hours) using this medicine. You may drink water (plain, flavored, or sweetened), fruit juices without pulp, and caffeine-free carbonated beverages during this time when you cannot eat.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Diarrhea, nausea, stomach pain
• Headache, cough, nosebleed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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