Galafold

Treatment with Galafold should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease. 4). Posology The recommended dosage regimen is 123 mg migalastat (1 capsule) taken once every other day at the same time of the day.

Missed dose Galafold 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 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 at the next planned dosing day and time according to the every other day dosing schedule.

2). 2). 2). 2). Children <12 years The safety and efficacy of Galafold in children aged less than 12 years have not yet been established. No data are available. Method of administration For oral use. 2). 5). Water (plain, flavored, sweetened), fruit juices without pulp, and caffeine-free carbonated beverages can be consumed during the 4-hour fasting period.

Galafold 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.

Summary of the safety profile The most common adverse reaction was headache, which was experienced by approximately 10% of patients who received Galafold. Tabulated list of adverse reactions Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing frequency within each System Organ Class. 2). No age-specific differences in adverse reactions were observed between adolescent and adult subjects.

The frequency, type and severity of adverse reactions in adolescents are expected to be the same as in adults based on these data. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 0 6

It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on or switched to migalastat. In case of meaningful clinical deterioration, further clinical evaluation or discontinuation of treatment with Galafold should be considered.

1). No reduction in proteinuria was observed in patients treated with Galafold. 2). Limited data suggest that co-administration of a single dose of migalastat and a standard enzyme replacement therapy infusion results in an increased exposure to agalsidase of up to 5-fold.

This study also indicated that agalsidase has no effect on the pharmacokinetics of migalastat. Galafold is not intended for concomitant use with enzyme replacement therapy. 2).

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