opfolda miglustat 65 mg
1 INDICATIONS AND USAGE OPFOLDA is indicated, in combination with Pombiliti, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). OPFOLDA is an enzyme stabilizer indicated, in combination with Pombiliti, a hydrolytic lysosomal glycogen-specific enzyme, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). ( 1 )
amicus therapeutics us, llc
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied OPFOLDA (
MIGLUSTAT) capsules are supplied as 65 mg, white opaque hard gelatin capsules with a grey opaque cap with “AT2221” printed in black on the body, and are available in bottles with child resistant caps. See Table 5 for the available OPFOLDA packages. Table 5. OPFOLDA Packages Package Size NDC 4 count bottle 71904-300-01 24 count bottle 71904-300-02 100 count bottle 71904-300-03 Storage and Handling Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F), [see USP Controlled Room Temperature]. Store in the original container to protect from light.
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