Galafold Capsule (Migalastat Hydrochloride)

Adult dose

This medication should be administered under the supervision of a physician experienced in the diagnosis and treatment of Fabry disease and should not be used in combination with enzyme replacement therapy. The recommended dose in adults is 1 capsule (equivalent to 123mg of migalastat) every 2 days, at the same time each time. Do not take this medication on 2 consecutive days. If a dose is missed, take the missed dose only if it is within 12 hours of the usual dosing time. If more than 12 hours have passed, resume dosing at the same time on the next scheduled dosing day, following the every-other-day schedule. Because taking this medication with food or caffeine decreases exposure by approximately 40 % and 60 %, respectively, do not consume food or caffeine within 2 hours before or after taking this medication, to maintain a fast of at least 4 hours. During this 4-hour fasting period, water, clear beverages containing 50g or less of glucose (e.g., no more than 250 mL of apple juice without pulp), or non-caffeinated beverages (including caffeine-free carbonated beverages) may be consumed. To achieve an adequate effect, patients should take this medication at the same time every other day. Swallow the capsule whole without cutting, crushing, or chewing it. Patients with renal impairment Administration of this medication is not recommended in patients with severe renal impairment (estimated glomerular filtration rate (eGFR) less than 30mL/min/1.73 m2). Patients with hepatic impairment No dose adjustment is required in patients with hepatic impairment.

Child dose

In adolescents 12 years of age or older weighing 45kg or more: Administer 1 capsule (equivalent to 123mg of migalastat) every 2 days, at the same time each time.

This medicine should not be used in patients with allergic reactions to the active ingredient or any of its components. Patients taking this medicine for the first time or switching from another medication to this one should be especially cautious, and regular kidney function tests and heart evaluations are essential. This medicine is not recommended for patients with severely impaired kidney function or those receiving enzyme replacement therapy. Women who are pregnant, may become pregnant, or are breastfeeding should exercise caution when using this medicine. The most common side effect of this medicine is headache, and other possible effects include dizziness, nausea, diarrhea, rash, and muscle pain. It does not significantly affect the ability to drive or operate machinery, but caution is advised if unusual symptoms occur. Using this medicine with caffeine may diminish its effectiveness, so it is advisable to avoid caffeine for 2 hours before and after taking this medicine. Due to potential effects on the fetus, this medicine is not recommended for use in pregnant women, and nursing mothers should consider the impact on their babies when deciding on its use. Safety for children under 12 years or adolescents with low body weight has not been established, so use should be avoided. Elderly patients over 65 years can use this medicine without special dose adjustments, but those with reduced kidney function should be cautious as drug exposure may increase. Overdose may lead to headaches and dizziness, and immediate consultation with a healthcare professional is necessary. Store this medicine out of reach of children, and it is safe to keep it in its original container.

• Depression
• headache
• paresthesia
• dizziness
• numbness
• vertigo
• palpitations
• shortness of breath
• epistaxis
• diarrhea

This medicine should be stored in a tightly sealed container to protect it from air and moisture. Maintaining a storage temperature between 1 degree and 30 degrees Celsius is recommended.

Appearance

A hard capsule with a blue upper part printed with A1001 and a white lower part, filled with a white to light brown powder.

Package unit

14 capsules/PTP