Galafold Amenability Table

Search GLA Gene Variants

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

Indication

Galafold® (migalastat) 123 mg capsules 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.

Enter either a DNA change or protein change.

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 mutiple GLA gene variants on the same chromosome.

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.

Enter up to three GLA gene variants:

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).

Last Updated: June 2024

INDICATION

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.

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS
The most common adverse reactions reported with Galafold (>10 %) were headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.

DRUG INTERACTIONS
Avoid co-administration 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 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information.