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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.

Access resources and support for you and your office

Rebecca and her son Anthony, living with Fabry disease
Quicklinks

Downloadable resources for your practice

Start a patient

Download the Galafold Patient Referral Form, which serves both as a prescription for Galafold in some states and a referral to AMICUS ASSIST®.

Download

Volume of Distribution

Learn more about Galafold and its volume of distribution.

Download

Renal Impact of Fabry Disease

Discover more about the impact Fabry disease has on the kidneys and other organ systems, and how treatment with Galafold may help.

Download

Galafold® MyDay App Postcard

Help your patients establish a dosing regimen with Galafold by using the Galafold® MyDay app. Download this postcard to have on hand to give to your Galafold patients.

Download

Genetic testing is the standard for diagnosis and management of Fabry disease1-4

  • Consider using genetic testing to identify a pathogenic GLA variant to diagnose Fabry disease
  • Partner with a genetics professional, such as a geneticist or genetic counselor, who is easily accessible to you and your patient. This can assist both you and your patient along the journey
  • Set expectations for your patients before testing can occur. Your genetics partner can help

Galafold® (migalastat) 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.

Whether a certain amenable GLA variant in a patient with Fabry disease is disease-causing or not should be determined by the prescribing physician (in consultation with a clinical genetics professional, if needed) prior to treatment initiation with Galafold.

Contact your Amicus Rare Disease Specialist for more on genetic testing.
Request More Information

Genetic Testing for Fabry Disease

Find out when to consider genetic testing for Fabry disease and how to order a genetic test and work with genetics professionals.

Download

Visit resources for your practice

Help your patients get support
with AMICUS ASSIST®

AMICUS ASSIST is a program designed to provide education, assistance, and support in gaining access to Galafold to eligible patients with Fabry disease and an amenable GLA variant.*
Visit Now
*
Patients must be prescribed Galafold to enroll in AMICUS ASSIST.

Learn more about Fabry disease at FabryFacts.com

Understand more about the complexities of this disease, including signs, symptoms, how diagnosis can vary between genders, and much more.
Visit Now
*
Patients must be prescribed Galafold to enroll in AMICUS ASSIST.
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.

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

Find out what Galafold can offer for your adult patients with Fabry disease and an amenable GLA variant

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