Migalastat

Migalastat

Migalastat

What is Migalastat?

Migalastat is used to treat Fabry disease in adults.

Migalastat received “accelerated” approval from the U.S. Food and Drug Administration (FDA). In clinical trials, some people responded to migalastat, but more studies are needed.

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

Side effects of migalastat

If necessary, get emergency medical helpSigns 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 urinating.

Common side effects of migalastat 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

Follow all instructions on the label and packaging of your medicine. Tell each of your healthcare providers about all your medical conditions, allergies and any medications you take.

Before you take this medicine

Tell your doctor if you have ever had kidney problems.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant or breast-feeding, your name may be added to a registry to track the effects of migalastat on the baby.

Migalastat is not approved for use by people under 18 years of age.

How should I take migalastat?

Follow all instructions on your prescription label and read any medication guides or instructions for use. 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 migalastat 2 days in a row.

Store at room temperature, protected from moisture and heat. Store unused capsules in the blister pack.

Migalastat dosage information

Usual adult dose for Fabry disease:

123 mg orally once every other day
– Take on an empty stomach at the same time of day; Do not eat for at least 2 hours before and 2 hours after taking the medication. Clear liquids may be drunk during this time

Comments:
-This medication should not be taken for 2 consecutive days.
-Patients with Fabry disease should have an accessible galactosidase alpha (GLA) gene variant that is interpreted by a clinical geneticist as pathogenic or likely to cause Fabry disease.
-This drug approval is subject to accelerated approval based on reduction of globotriaosylceramide substrate (KIC GL-3) in renal interstitial capillary cells. Further approval is subject to demonstrated clinical benefit.

Use: For the treatment of adults with Fabry disease and an accessible galactosidase alpha gene variant (GLA), based on in vitro assay data.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking migalastat?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs will affect migalastat?

Other medications can affect migalastat, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

• Wie viel kostet Galafold?

More information

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