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Galafold

Generic name: migalastat [mig-GAL-a-stat]
Drug class: Miscellaneous metabolic agents

What is Galafold?

Galafold stabilizes and binds to a specific enzyme called alpha-galactosidase. A deficiency in this enzyme is known as Fabry's disease. Galafold is used in the treatment of Fabry disease among adults. The FDA approved Galafold on an "accelerated basis." Some people have responded to the medicine in clinical studies. However, further research is needed.

Warnings

Please follow all instructions listed on your medication's package or label, inform your healthcare provider of any medical conditions or allergies you have, and inform them which medicines you are currently taking.

Before you take this drug

Galafold should not be used if you have an allergy to migalastat. Inform your doctor if kidney problems have ever occurred. Inform your doctor immediately if you are pregnant or nursing. You may find your name on a registry if you are breastfeeding or pregnant. This is to monitor the effects of the migalastat drug on the child. Galafold is not recommended for anyone under the age of 18.

How to take Galafold?

Galafold should be taken exactly as prescribed by a doctor. Please read the instructions on your prescription label. This medicine should be taken on an empty stomach at least two hours before or after eating. Every other day at the same time, galafold is taken. Do not open, crush, chew, or break the capsule. Do not take this medication two days in a row. Store away from moisture or heat. Keep capsules in blister packs.

Similar/related drugs

Fabrazyme, Elfabrio, Agalsidase Beta, and Migralastat

Details on dosage

Adult dose for Fabry disease:
Orally, take 123 mg every alternate day.
Take on an empty stomach. Do not eat or drink for 2 hours prior to and 2 hours following the dose. Clear liquids are allowed during this time.
Comments:
This drug should not be taken for two days in a row.
Patients who have Fabry should have a pathogenic or likely pathogenic galactosidase beta gene variant (GLA), which is interpreted as such by a clinical geneticist.
This drug approval is under an accelerated approval based on a reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate; continued approval is subject to demonstrated clinical benefit.
Use: To treat adults with Fabry and a galactosidase-alpha gene variant that is amenable based on data from in vitro tests.

What happens if I miss the dose?

If you miss a dose, take it immediately or wait 12 hours and take another dose if the missed one was more than 24 hours ago. Do not take two doses at the same time of any medication.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

If your doctor prescribes restrictions about food, beverage or activity consumption or physical activities for you to complete, please follow their directives accordingly.

Side effects of Galafold

If you experience any of the following: hives, difficulty breathing, swelling of the face, lips, or throat, and/or difficulty breathing, seek emergency medical attention.

If you experience:

  • You may experience pain or burning after urinating.

Galafold's side effects include:

  • Headache;
  • Nausea;
  • Fever;
  • Cold symptoms like a stuffy nose and sneezing.

There may be other side effects. For medical advice on side effects, call your doctor. Contact the FDA by dialing 1-800-FDA-1088 in order to report side effects.

Interaction with other drug

Other drugs, such as vitamins and herbal remedies, may interact with migalastat. Informing your physician of all medications you are currently taking and those that you take, stop using or start to take is very important for proper diagnosis and management.