Active Ingredient: Migalastat
Migalastat is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
123 - 123 mg
From 123 To 123 mg once every 2 day(s)
The recommended dosage regimen in adults and adolescents 16 years and older is 123 mg migalastat once every other day at the same time of day.
Migalastat 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 migalastat 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 migalastat at the next planned dosing day and time according to the every other day dosing schedule.
Migalastat exposure is decreased by approximately 40% when taken with food and therefore food should not be consumed at least 2 hours before and 2 hours after taking migalastat to give a minimum 4 hours fast. Clear liquids, including carbonated drinks, can be consumed during this period. Migalastat should be taken every other day at the same time of day to ensure optimal benefits to the patient.
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