RELYVRIO
Generic Name/API: sodium phenylbutyrate and taurursodiol
Manufacturer: Amylyx Pharmaceuticals, Inc.
Dosage Forms & Strength & Pack Size:
For oral suspension: 3 g sodium phenylbutyrate and 1 g taurursodiol in single dose packets
Storage:
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.
INDICATION
RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis
(ALS) in adults.
IMPORTANT SAFETY INFORMATION
RELYVRIO may cause serious side effects, including: Changes in bile acid levels. RELYVRIO may increase bile acid levels and cause worsening diarrhea if you already have problems with your liver, bile ducts, or pancreas. Your healthcare provider should monitor you for these side effects.
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