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Request more information or a visit from your Amicus Rare Disease Specialist

Find out if Galafold® (migalastat) may be an appropriate treatment for your adult patients with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant. Once you submit your request, a representative will contact you.

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INDICATIONS AND USAGE

Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see accompanying
‍Full Prescribing Information.

IMPORTANT SAFETY INFORMATION
ADVERSE REACTIONS

The most common adverse drug reactions reported with Galafold (≥10 %) are headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.

DRUG INTERACTIONS

Avoid coadministration of Galafold with caffeine at least 2 hours before and 2 hours after taking Galafold.

USE IN SPECIFIC POPULATIONS

There is insufficient clinical data on Galafold use in pregnant women to inform a drug associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.

It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition.

Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis.

The safety and effectiveness of Galafold have not been established in pediatric patients.

To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4-AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying
‍Full Prescribing Information.
INDICATIONS AND USAGE

Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Connect your patients to the support they need

Alex, living with Fabry disease
Quicklinks

Help patients make Galafold part of their routine

  • The recommended dose of Galafold is 123 mg orally once every other day at the same time of day1
  • Galafold should be taken on an empty stomach1 to ensure optimal absorption
  • Do not consume food or caffeine at least 2 hours before and 2 hours after taking Galafold to give a minimum 4 hours fast1
  • The following liquids may be consumed during the 4-hour fasting period1:
    • Water (plain, flavored, or sweetened)
    • Fruit juices without pulp
    • Caffeine-free carbonated beverages
Do not consume food or caffeine 2 hours before and after taking GalafoldDo not consume food or caffeine 2 hours before and after taking Galafold
INDICATIONS AND USAGE

Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Help patients establish a routine

Establishing a routine for taking Galafold that fits into patients’ lifestyles may help them stay compliant with the prescribed Galafold dosing regimen.

One option to help patients keep track of their Galafold routine is the Galafold® MyDay app. The app will send reminders:

  • Every other day to let them know when it’s a Galafold day
  • Before and after they take Galafold (to inform them when to begin and end fasting)
  • When it’s time for a prescription refill, and more
Apple, the Apple logo, App Store, and iPhone are trademarks of Apple Inc., registered in the U.S. and other countries and regions. Google Play and the Google Play logo are trademarks of Google LLC.
Download the Galafold MyDay app for Apple devices Download the Galafold MyDay app for Apple devices Download the Galafold MyDay app for Android devices

Dedicated support with AMICUS ASSIST®

Once prescribed Galafold and enrolled in the program, AMICUS ASSIST will provide patients with a dedicated support team consisting of a Patient Education Liaison (PEL) and a Case Manager.*

Dedicated PELs can offer education and support to patients by:

Educating about Fabry disease and your patient’s Amicus medication

Providing tips to help patients establish a treatment routine

Helping patients have more productive conversations with their care team

PELs do not give medical advice or take the place of the patient’s healthcare provider.

What is a Case Manager?

Case Managers can help patients navigate treatment access and financial assistance by:

Helping navigate their insurance coverage

Helping to coordinate prescription delivery

Identifying possible sources of financial assistance

How can they both help?

With the combined knowledge and expertise of a PEL and a Case Manager, AMICUS ASSIST provides a two-pronged approach to ensure that your Fabry patients have access to the information and support they need.

*
Patients must be prescribed Galafold for an approved indication to be eligible for support from AMICUS ASSIST.
Connect with AMICUS ASSIST toll-free at: 1-833-AMICUS-A (1-833-264-2872), Monday through Friday, from 8 AM to 8 PM ET.
For more information about AMICUS ASSIST, please visit www.AmicusAssist.com.

Additional information for
patients is available

For patients looking for more information about their treatment, the Galafold patient website is available. Patients can learn more about how Galafold works, hear from other Galafold patients, and access more resources.

Visit the Galafold Patient Website

Patient advocacy organizations

FSIG: Fabry Support &
Information Group
Visit
National Fabry
Disease Foundation
Visit
Genetic Alliance
Visit
Rare Disease
Legislative Advocates
Visit
NORD: National Organization for Rare Disorders
Visit
Global Genes: Allies
in Rare Disease
Visit
EveryLife Foundation for Rare Diseases
Visit
Fabry International Network
Visit

Galafold® MyDay App Postcard

Download and give your patients this postcard to help them establish a routine by using the Galafold® MyDay app.

Download