What is Migalastat?
Migalastat is a drug that works by stabilizing and binding alpha-galactosidase A, an enzyme found in the human body. Fabris disease is a deficiency in this enzyme. Adults with Fabry's disease can be treated using Migalastat. Migalastat has been approved "accelerated" by the US Food and Drug Administration. Some people have responded positively to migalastat in clinical trials, but more studies are required.This medication guide does not list all possible uses of Migalastat.
Side effects of Migalastat
If you experience any of the following symptoms of an allergy: difficulty breathing, hives, swelling in your lips, face, throat, or tongue.
If you experience:
- You may experience pain or burning after urinating.
Migalastat may cause the following side effects:
- Headache;
- Nausea;
- Fever;
- Symptoms of a cold, including a stuffy nose and sneezing and a sore throat.
There may be other side effects. For medical advice on side effects, call your doctor. Report any side effects by calling the FDA at 1-800-FDA-1088.
Warnings
Please read all the instructions on the label or package of your medication. Inform your doctors about your allergies and medical conditions. Also inform them which medicines you are currently taking.
Before you take this drug
Inform your doctor about any kidney issues you may have had. Inform your doctor of any pregnancy or nursing. You may find your name on a registry if you're pregnant or nursing to monitor the effect of migalastat. Migalastat should not be used by those under the age of 18.
How to take Migalastat?
Read and follow all instructions or guides included with your medication, as well as those found on its prescription label. Migalastat should be taken on an empty stomach at least two hours before or after eating. Migalastat should be taken at the same time every day. Do not open, crush, chew on or break the capsule. Avoid taking migalastat for more than 2 consecutive days. Keep away from heat and moisture. Store unused capsules inside the blister.
Details on dosage
Adult dose for Fabry disease:
Orally, take 123 mg every alternate day.
Take it at the same time every day on an empty stomach. Do not eat or drink for 2 hours prior to and after taking this medication. Clear liquids are allowed during this time.
Comments:
This drug must not be taken for two days in a row.
Patients with Fabry should be found to have a pathogenic variant of the galactosidase beta gene (GLA), which is interpreted as such by a 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 GLA 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 as soon as possible. However, if the delay is more than 12 hours, you should skip that dose. Never take two doses of the same medicine at once.
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 any restrictions on foods, drinks, or activities, follow their instructions.
Interaction with other drug
Other medications, such as vitamins and herbal remedies, may also affect migalastat. Inform your doctor of all the medicines you are taking and those that you stop or start using.
