migalastat

Pronunciation: mi GAL a stat

Brand: Galafold

What is the most important information I should know about migalastat?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is migalastat?

Migalastat works by binding to and stabilizing a certain enzyme in the body called alpha-galactosidase A. A deficiency of this enzyme is called Fabry disease.

Migalastat is used to treat Fabry disease in adults.

Migalastat was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Migalastat may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking migalastat?

You should not use migalastat if you are allergic to it.

Tell your doctor if you have ever had kidney problems.

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

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Migalastat is not approved for use by anyone younger than 18 years old.

How should I take migalastat?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take migalastat on an empty stomach, at least 2 hours before or 2 hours after a meal.

Migalastat is usually taken every other day, at the same time of day.

Swallow the capsule whole and do not crush, chew, break, or open it.

Do not take this medicine 2 days in a row.

Store at room temperature away from moisture and heat. Keep unused capsules in the blister pack.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking migalastat?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of migalastat?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have:

  • pain or burning when you urinate.

Common side effects may include:

  • headache;
  • nausea;
  • fever; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect migalastat?

Other drugs may affect migalastat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about migalastat.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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migalastat