Patient Selection

Select adults with confirmed Fabry disease who have an amenable GLA variant for treatment with GALAFOLD [see Table 2 in Clinical Pharmacology (12.1)].

Treatment is indicated for patients with an amenable GLA variant that is interpreted by a clinical genetics professional as causing Fabry disease (pathogenic, likely pathogenic) in the clinical context of the patient. 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).

Recommended Dosage and Administration

The recommended dosage regimen of GALAFOLD is 123 mg orally once every other day at the same time of day (do not take GALAFOLD on 2 consecutive days). Swallow capsules whole: do not cut, crush, or chew the capsules.

Take GALAFOLD on an empty stomach. Do not consume food or caffeine at least 2 hours before and 2 hours after taking GALAFOLD to give a minimum 4 hours fast [see Clinical Pharmacology (12.3)].

Water (plain, flavored, sweetened), fruit juices without pulp, and caffeine-free carbonated beverages can be consumed during the 4-hour fasting period.

Recommendations for a Missed Dose

If a dose is missed entirely for the day, take the missed dose of GALAFOLD only if it is within 12 hours of the normal time that the dose should have been taken. If more than 12 hours have passed, resume taking GALAFOLD at the next planned dosing day and time, according to the every-other-day dosing schedule.