Posology : מינונים

4.2 Posology and method of administration

Treatment with Galafold 123mg should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease. Galafold 123mg is not intended for concomitant use with enzyme replacement therapy (see section 4.4).

Posology

The recommended dosage regimen is 123 mg migalastat (1 capsule) taken once every other day at the same time of day.

Missed dose

Galafold 123mg should not be taken on 2 consecutive days. If a dose is missed entirely for the day, the patient should take the missed dose of Galafold 123mg only if it is within 12 hours of the normal time the dose is taken. If more than 12 hours has passed, the patient should resume taking Galafold 123mg at the next planned dosing day and time according to the every other day dosing schedule.

Special populations

Elderly population
No dosage adjustment is required based on age (see section 5.2).

Renal impairment

Galafold 123mg is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m2 (see section 5.2).


Hepatic impairment
No dosage adjustment of Galafold 123mg is required in patients with hepatic impairment (see section 5.2).

Paediatric population

Adolescents aged ≥ 12 to < 18 years and weighing ≥ 45 kg
123 mg migalastat (1 capsule) taken once every other day at the same time of the day (see section 5.2).

Children < 12 years
The safety and efficacy of Galafold 123mg in children aged less than 12 years have not yet been established. No data are available.

Method of administration

For oral use.
Galafold 123mg exposure is decreased by approximately 40% when taken with food and 60% when taken with coffee (see sections 4.5 and 5.2). Food and caffeine should not be consumed at least 2 hours before and 2 hours after taking Galafold 123mg to give a minimum 4 hours fast (see section 4.5).

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

Galafold 123mg should be taken every other day at the same time of day to ensure optimal benefits to the patient.
Capsules must be swallowed whole. The capsules must not be cut, crushed, or chewed.