Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Amicus Therapeutics Europe Limited, Block 1, Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland Tel: +353 (0) 1 588 6850, Fax: +353 (0) 1 588 6851, e-mail: info@amicusrx.co.uk ...
Galafold 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 (see the tables in section 5.1).
Treatment with Galafold should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease. Galafold is not intended for concomitant use with enzyme replacement therapy (see section 4.4).
The recommended dosage regimen in adults and adolescents 16 years and older is 123 mg migalastat (1 capsule) once every other day at the same time of day.
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.
The safety and efficacy of Galafold in children aged 0 to 15 years has not yet been established. No data are available.
No dosage adjustment is required based on age (see section 5.2).
Galafold 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).
No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
For oral use. Galafold 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 Galafold to give a minimum 4 hours fast. Clear liquids, including carbonated drinks, can be consumed during this 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.
In case of overdose, general medical care is recommended. Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
Shelf life: 4 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
PVC / PCTFE / PVC/Al blister.
Pack size of 14 capsules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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