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Request a visit from your Galafold® (migalastat) Rare Disease Specialist

Find out if Galafold may be an appropriate treatment for your 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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Important safety information AND INDICATION

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

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

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.

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.

Keep Your Fabry Patients

MOVING FORWARD

Consider how the first and
only oral therapy may help

For adults with confirmed Fabry disease and an amenable galactosidase alpha gene (GLA) variant associated with either the classic* or non-classic phenotype1,2

*

Defined as males with residual peripheral blood mononuclear cell alpha-galactosidase A (alpha-Gal A) <3% of normal and multiorgan system involvement.

Not an actual patient with Fabry disease.

Not an actual patient with Fabry disease.

Keep Your Fabry Patients

MOVING FORWARD

Consider how the first and only oral therapy may help

For adults with confirmed Fabry disease and an amenable galactosidase alpha gene (GLA) variant associated with either the classic* or non-classic phenotype1,2

*

Defined as males with residual peripheral blood mononuclear cell alpha-galactosidase A (alpha-Gal A)

INDICATIONS AND USAGE

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.

Check if your patient’s GLA variant is
amenable to Galafold
LEARN MORE

Help your patients get support with Amicus Assist®

AMICUS ASSIST is a program designed to provide assistance and support to help eligible patients with Fabry disease and an amenable GLA variant obtain access to Galafold.*

*Patients must be prescribed Galafold for an approved indication to be eligible for support from AMICUS ASSIST.

VISIT NOW

Download the Galafold Patient Referral Form

This form serves a dual purpose: as a prescription for Galafold and as a way for patients to register for AMICUS ASSIST.

DOWNLOAD NOW

Learn about an option for genetic testing for Fabry disease

Learn about a no-charge option for genetic testing to help you confirm a diagnosis and determine your patient’s specific GLA variant.

LEARN MORE