Uses

This medication is used for long-term treatment in people with a certain inherited disease (Fabry disease). In Fabry disease, a certain enzyme in your body (alpha-galactosidase) does not work the way it should. This leads to a buildup of a certain fatty substance in your kidneys, heart, and other organs. Migalastat works by helping alpha-galactosidase work better so it can remove the fatty substance. Treatment can decrease some symptoms caused by Fabry disease, such as abdominal cramps, diarrhea, burning pain in the hands and feet, heat intolerance, skin rash, kidney/heart disease, or stroke.

How To Use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking migalastat and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach as directed by your doctor, usually once every other day. Do not take this medication 2 days in a row. Swallow the capsules whole. Do not cut, crush, or chew the capsules.

Do not eat food or take or drink any product that contains caffeine at least 2 hours before and 2 hours after taking this medication. During this time, you may drink water (plain, flavored, or sweetened), fruit juices without pulp, and caffeine-free carbonated beverages. Taking this medication with food or caffeine will make it work less well. Check the labels on all your medicines (such as allergy or cough-and-cold products, pain relievers) because they may also contain caffeine.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time every other day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Headache, nausea, abdominal pain, dry mouth, diarrhea, runny/stuffy nose, nosebleed, numbness/tingling, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of bladder infection (such as burning/pain when you urinate, urgent or frequent urination, fever)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking migalastat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• agalsidase

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as kidney function, heart function, specific markers for Fabry disease) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember if it is later the same day and within 12 hours of your normal dosing time. If you miss a dose for an entire day, skip the missed dose. Wait and take your next dose at the regular time on the next day. Do not take this medication 2 days in a row. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep the medication in the blister pack until ready to use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.