Why is this medicine prescribed?
Migalastat is used to treat Fabry disease (an inherited condition in which a type of fatty substance builds up in the body, resulting in nerve and organ damage). Migalastat is in a class of medications called alpha-galactosidase A (alpha-Gal A) pharmacological chaperones. It works by improving the function of a protein in the body to help break down fatty substances in the body.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Migalastat comes as a capsule to take by mouth. Take once every other day on an empty stomach. Take migalastat at around the same time every other day.
Do not eat food or drink caffeine at least 2 hours before and 2 hours after taking migalastat. You can drink water, fruit juices (without pulp), and other caffeine-free beverages during this 4 hour period.
Take migalastat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not split, chew, or crush them.
Migalastat capsules come in a blister card containing 14 capsules (for 28 days of treatment). Before you take migalastat for the first time, read the written instructions for the patient that come with the medication. Ask your doctor or pharmacist if you have any questions about taking migalastat.
Migalastat controls Fabry disease but does not cure it. Continue to take migalastat even if you feel well. Do not stop taking migalastat without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
What special precautions should I follow?
Before taking migalastat,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- if you are taking caffeine or medications that contain caffeine (Cafcit®, Excedrin®, Lanorinal®, NoDoz®, Orphengesic®, Vivarin®), take them at least 2 hours before
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you have or have ever had kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking migalastat, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
If you remember the missed dose within 12 hours of the time you were scheduled to take it, take the missed dose right away. However, if more than 12 hours have passed since the time you usually take it, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Migalastat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- cough, congestion, runny nose, or sore throat
- fever
- nausea
- vomiting
- diarrhea
- stomach pain
- nosebleed
- back pain
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- frequent, urgent, burning, or painful urination; decrease in amount of urine; urine that is cloudy, red, pink, or brown; strong smelling urine; pelvic or rectal pain; fever; or back pain
- swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles or lower legs
Migalastat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before you begin your treatment to see whether your condition can be treated with migalastat. Your doctor may also order certain lab tests to check your body's response to migalastat.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.