Uses
What is Galafold used for?
Galafold (migalastat) is commonly used for a rare inherited condition called Fabry disease.
Galafold may also be used for other conditions as determined by your healthcare provider.
How does Galafold work (mechanism of action)?
A specific enzyme, called alpha-galactosidase A, does not work correctly in people with Fabry disease. Over time, this causes a certain type of fatty substance to build up in the body, which can cause serious health issues.
In some types of Fabry disease, the enzyme does not work at all. In other types, the enzyme is unstable and does not work as well as it should. Galafold is used in people with the unstable form of the enzyme. It binds to the enzyme, keeping it stable so that it can work correctly. This allows the enzyme to stop the fatty substance from building up in the body.
Learn more about How Galafold Works for Fabry Disease.
How is Galafold supplied (dosage forms)?
Galafold is available as a 123 mg oral capsule that is taken by mouth.
How should I store Galafold?
Galafold should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in the original package in a cool, dry place.
Side Effects
What are the most common side effects of Galafold?
The most common side effects of Galafold are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Fever
- Headache
- Infection in the nose or throat, sore throat, or common cold symptoms
- Kidney or bladder infection
- Nausea
There may be other side effects of Galafold that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Galafold?
While less common, the most serious side effects of Galafold are described below, along with what to do if they happen.
Severe Allergic Reactions. Galafold may cause allergic reactions, which can be serious. Stop taking Galafold and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Warnings & Precautions
Who should not use Galafold?
Allergies to Ingredients. People who are allergic to any of the following should not take Galafold.
- Galafold
- Migalastat
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Galafold.
What should I know about Galafold before using it?
Do not take Galafold unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Galafold with other people, even if they have the same condition as you. It may harm them.
Keep Galafold out of the reach of children.
Swallow Galafold whole. Do not chew, cut, or crush the capsule.
Most people will be told to take Galafold every other day. If you are told to take Galafold every other day, it is important to keep track of your doses so that you do not take it two days in a row.
What should I tell my healthcare provider before using Galafold?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Galafold is right for you.
In particular, make sure that you discuss any of the following.
Drug Interactions. Galafold may interact with other medicines and supplements. Before taking Galafold, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Kidney Problems. Tell your healthcare provider about any recent or current kidney problems.
Pregnancy. It is not known if or how Galafold could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Galafold while you are pregnant or trying to get pregnant. If you become pregnant while taking Galafold, you can register for the Fabry Pregnancy Registry by calling 888-239-0758 or at www.fabrypregnancyregistry.com. This registry collects safety information about people with Fabry disease during pregnancy.
Breastfeeding. It is not known if Galafold passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Galafold?
For more information about Galafold, you can visit the manufacturer’s website at www.galafold.com or call them at 877-426-4287.
Interactions
Does Galafold interact with foods or drinks?
Galafold should be taken on an empty stomach. Avoid taking Galafold within 2 hours before food and within 2 hours after food. During this time, you can drink flavored or plain water, fruit juices without pulp, and caffeine-free carbonated beverages.
Caffeine can lower the levels of Galafold in the body. Do not have any drinks that contain caffeine within 2 hours before taking Galafold or 2 hours after taking Galafold.
It is unknown if drinking alcohol will affect Galafold.
Does Galafold interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any products that contain caffeine. Caffeine is often found in medicines for reducing water weight (diuretics), staying awake, headaches, and hangover relief.
This may not be a complete list of medicines that can interact with Galafold. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Galafold?
If you or someone else has used too much Galafold, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Galafold?
If you miss a dose, take it as soon as you remember. If it has been more than 12 hours since your missed dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
Are you currently using Galafold (migalastat)?
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