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Safety and tolerability1

Adverse reactions occurring in ≥5% of adult patients with PBC treated with LYNAVOY in GLISTEN study (24 weeks)*

Adverse Reaction LYNAVOY
(n=119)
n (%)		 Placebo
(n=118†)
n (%)
Diarrhea‡ 74 (62) 21 (18)
Abdominal pain§ 31 (26) 12 (10)
Nausea 12 (10) 11 (9)
Increased ALT 11 (9) 4 (3)
Hemorrhage|| 11 (9) 3 (3)
Increased AST 10 (8) 1 (<1)
Headache 10 (8) 4 (3)
Dyspepsia 9 (8) 1 (<1)
Gastroesophageal reflux disease 8 (7) 5 (4)
Abdominal distension 8 (7) 6 (5)
Dizziness 7 (6) 4 (3)
Arthralgia 7 (6) 6 (5)

Drug discontinuation due to adverse reactions occurred in 14% of LYNAVOY-treated patients and 5% of placebo-treated patients.

*Adverse reactions were only included in table if they occurred more frequently in patients treated with LYNAVOY compared to placebo-treated patients.

†One patient randomly assigned to the placebo group withdrew before receiving treatment.

‡Diarrhea includes diarrhea and frequent bowel movements.

§Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort.

||Hemorrhage includes contusion, ecchymosis, epistaxis, gastric hemorrhage, hematochezia, hemorrhagic disorder, intermenstrual bleeding, melena, petechiae, skin hemorrhage, vaginal hemorrhage, hematocrit decreased, and diarrhea hemorrhagic.

ALT=alanine aminotransferase; AST=aspartate aminotransferase.

See LYNAVOY dosing

Important Safety Information

Warnings and Precautions

Liver Test Elevations were observed more commonly in LYNAVOY-treated patients compared to placebo-treated patients.

  • Obtain baseline liver tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin [TB], direct bilirubin [DB], alkaline phosphatase [ALP]) prior to initiating treatment with LYNAVOY and monitor the levels per standard clinical practice for PBC patients during treatment with LYNAVOY.
  • If new liver test elevations occur, monitor ALT, AST, TB, DB, and ALP more frequently.
  • If liver test elevations persist, discontinue LYNAVOY.

Diarrhea was reported as the most common adverse reaction in patients treated with LYNAVOY.

  • If diarrhea occurs, advise patients to monitor for dehydration.
  • Consider interrupting or discontinuing LYNAVOY treatment if diarrhea persists.

Fat-Soluble Vitamin (FSV) Deficiency: LYNAVOY may adversely affect absorption of FSV (i.e., vitamins A, D, E, and K).

  • Obtain serum levels for vitamins A, D, and E and INR prior to initiation of LYNAVOY.
  • Monitor the levels periodically during treatment, along with any clinical manifestations of FSV deficiency.
  • Supplement with FSV if a deficiency is diagnosed.
  • Consider discontinuing LYNAVOY if FSV deficiency persists or worsens despite adequate supplementation.
  • Bleeding was observed more frequently in LYNAVOY-treated patients compared to placebo-treated patients.
    • If bleeding occurs, interrupt LYNAVOY treatment and evaluate for potential FSV deficiency.
    • LYNAVOY can be restarted if FSV deficiency is corrected, levels are maintained, and bleeding has resolved.
  • Bone Fracture has been associated with IBAT inhibitors.
    • Monitor bone health and ensure adequate FSV levels.

Adverse Reactions

The most common adverse reactions (≥5%) are diarrhea, abdominal pain, nausea, increased ALT, hemorrhage, increased AST, headache, dyspepsia, gastroesophageal reflux disease, abdominal distension, dizziness, and arthralgia.

Drug Interactions

  • Effect of Bile Acid Binding Resins on LYNAVOY: Administer at least 4 hours before or 4 hours after administration of LYNAVOY.

To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals 1-844-782-4278 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see the full Prescribing Information for LYNAVOY.

Indication:

LYNAVOY (linerixibat) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients.

Limitations of Use: Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy).

References

  1. 1. LYNAVOY (linerixibat) Prescribing Information. Morristown, NJ: Intercept Pharmaceuticals. 2026.
  2. 2. Alfasigma. Linerixibat approved for use in the U.S. for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC). Press release. March 19, 2026. Accessed June 3, 2026. https://www.alfasigma.com/corporate/linerixibat-approved-for-use-in-the-u-s-for-the-treatment-of-cholestatic-pruritus-in-primary-biliary-cholangitis-pbc/
  3. 3. Hegade VS, Kendrick SFW, Dobbins RL, et al. Effect of ileal bile acid transporter inhibitor GSK2330672 on pruritus in primary biliary cholangitis: a double blind, randomised, placebo-controlled, crossover, phase 2a study. Lancet. 2017;389(10074):1114-1123. doi:1016/S0140-6736(17)30319-7
  4. 4. Kode V, Yimam KK. Cholestatic pruritus: pathophysiology, current management approach, and emerging therapies. Curr Hepatol Rep. 2024;23(19):1-14. doi:10.1007/s11901-024-00638-7
  5. 5. Naumann S, Haller D, Eisner P, Schweiggert-Weisz U. Mechanisms of interactions between bile acids and plant compounds—a review. Int J Mol Sci. 2020;21(18):6495. doi:10.3390/ijms21186495
  6. 6. Hirschfield GM, Bowlus CL, Jones DEJ, et al. Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026;11(1):22-33. doi:10.1016/S2468-1253(25)00192-X
  7. 7. Data on File. Intercept Pharmaceuticals, Inc.