Source: FDA, National Drug Code (US) Revision Year: 2022
RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
The recommended initial dosage of RELYVRIO for oral suspension is 1 packet (3 g sodium phenylbutyrate and 1 g taurursodiol) daily for the first 3 weeks. After 3 weeks, increase to the maintenance dosage of 1 packet twice daily.
Empty contents of one packet in a cup containing 8 ounces of room temperature water and stir vigorously. Take orally or administer via feeding tube within 1 hour of preparation. The reconstituted suspension may be stored for up to 1 hour at room temperature. Discard any unused RELYVRIO reconstituted suspension after 1 hour.
Administer RELYVRIO before a snack or meal.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. See Dosage and Administration (2.2) for storage of RELYVRIO reconstituted suspension.
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