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.

Identify whether your patient's
GLA variant is amenable to
treatment with Galafold

Not an actual patient with Fabry disease.

Identify whether your patient's GLA variant is amenable to treatment with Galafold

Search GLA variants

You can use this search tool to find out whether a specific GLA variant has been listed in the Full Prescribing Information as amenable to treatment with Galafold. The current list of amenable GLA variants can also be found in the Full Prescribing Information.

In the search bar below, enter either a DNA or protein change to determine amenability.

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. Consultation with a clinical genetics professional is strongly recommended in cases where the amenable GLA variant is of uncertain clinical significance (VUS, variant of uncertain significance) or may be benign (not causing Fabry disease).

This search bar is intended only for Healthcare Professionals licensed to practice in the United States.

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For DNA Change

Please use format c.#A>B or c.A#B for DNA changes, where 'c.' is optional; # indicates a number; A and B are letters. Examples: c.8T>C or c.T8C

For Protein Change

Protein changes can be written as either a single-letter or three-letter code. For example, p.(L3P) can be written as is or written as p.(Leu3Pro), where the ‘p.’ and ‘()’ is optional in both cases.

*Note: This is only for searching multiple GLA variants on the same chromosome.

In the search bars below, enter up to 3 GLA variants to determine amenability.

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. Consultation with a clinical genetics professional is strongly recommended in cases where the amenable GLA variant is of uncertain clinical significance (VUS, variant of uncertain significance) or may be benign (not causing Fabry disease).

This search bar is intended only for Healthcare Professionals licensed to practice in the United States.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

For DNA Changes

Please use format c.#A>B or c.A#B for DNA changes, where 'c.' is optional; # indicates a number; A and B are letters. Examples: c.8T>C or c.T8C

For Protein Change

Protein changes can be written as either a single-letter or three-letter code. For example, p.(L3P) can be written as is or written as p.(Leu3Pro), where the ‘p.’ and ‘()’ are optional in both cases.

You can also determine whether your patient's GLA variant is amenable by:

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.

Help your patients determine if their GLA variant is amenable to Galafold