Relyvrio

— THERAPEUTIC CATEGORIES —
  • Miscellaneous neurodegenerative disorders

Relyvrio Generic Name & Formulations

General Description

Sodium phenylbutyrate 3g, taurursodiol 1g; per packet; pwd for oral susp; mixed berry flavor; contains 464mg of sodium.

Pharmacological Class

Phenylacetate prodrug + ambiphilic bile acid.

How Supplied

Single-dose packets—7, 56

Generic Availability

NO

Relyvrio Indications

Indications

Amyotrophic lateral sclerosis (ALS).

Relyvrio Dosage and Administration

Adult

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

Not established. 

Relyvrio Contraindications

Not Applicable

Relyvrio Boxed Warnings

Not Applicable

Relyvrio Warnings/Precautions

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 Pharmacokinetics

See Literature

Relyvrio Interactions

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.

Relyvrio Adverse Reactions

Adverse Reactions

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

Relyvrio Clinical Trials

See Literature

Relyvrio Note

Not Applicable

Relyvrio Patient Counseling

See Literature