Miscellaneous neurodegenerative disorders:

Recent Updates:

Monograph added.

Indications for: RELYVRIO

Amyotrophic lateral sclerosis (ALS).

Adult Dosage:

Administer before a snack or meal. Mix contents of 1 packet with 8 oz of room temperature water. Take orally or administer via feeding tube within 1hr of preparation. 1 packet once daily for the first 3 weeks, then increase to maintenance dose of 1 packet twice daily.

Children Dosage:

Not established. 

RELYVRIO Warnings/Precautions:

Increased risk for worsening diarrhea in those with enterohepatic circulation disorders, pancreatic disorders, or intestinal disorders; may lead to decreased absorption of sodium phenylbutyrate/taurursodiol; monitor appropriately. Consider consulting a specialist in patients with disorders that interfere with bile acid circulation. Monitor the amount of daily sodium intake in patients sensitive to salt intake (eg, heart failure, hypertension, or renal impairment). Moderate or severe renal impairment: avoid. Moderate or severe hepatic impairment: avoid. Pregnancy. Nursing mothers.

RELYVRIO Classification:

Phenylacetate prodrug + ambiphilic bile acid.

RELYVRIO Interactions:

Avoid concomitant bile acid sequestering agents (eg, cholestyramine, colestipol, colesevelam); consider alternative cholesterol lowering agents. Avoid concomitant strong bile salt export pump inhibitors; if unavoidable, use caution and monitor serum transaminases and bilirubin. Avoid use of aluminum-based antacids; consider other acid lowering agents. Avoid concomitant probenecid, pan-histone deacetylase inhibitors, OATP1B3 inhibitors. Potentiates OAT1 substrates, P-gP and BCRP substrates, and drugs that are substrates of CYP2C8, CYP1A2, CYP2B6, and CYP3A4 isoenzymes; avoid use with these substrates; may lead to serious toxicities or loss of efficacy.

Adverse Reactions:

Diarrhea, abdominal pain, nausea, upper respiratory tract infection.

Generic Drug Availability:

NO

How Supplied:

Single-dose packets—7, 56