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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.

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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.

Goes Where Your Patients Go

Galafold is a 123 mg capsule
Find out what Galafold can offer as an oral option for your adult patients with Fabry disease and an amenable GLA variant
Rebecca and her son Anthony, living with Fabry disease

An oral option for adults with confirmed Fabry disease and an amenable galactosidase alpha gene (GLA) variant associated with either the classic* or non-classic phenotype.1,2

*

Defined as males with residual peripheral blood mononuclear cell alpha-galactosidase A (alpha-Gal A) <3% of normal and multiorgan system involvement.2

Start a Patient

Start a Patient

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

Download the form

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.†
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†
Patients must be prescribed Galafold to enroll in AMICUS ASSIST.

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

Use this search tool to find out whether a specific GLA variant has been listed in the Full Prescribing Information.
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†
Patients must be prescribed Galafold to enroll in AMICUS ASSIST.