Lynavoy

Lynavoy is a prescription medicine used to treat cholestatic pruritus associated with primary biliary cholangitis (PBC) in adults. Cholestatic pruritus is the severe itching that can occur when bile acids build up in people with PBC. Lynavoy contains linerixibat, a reversible inhibitor of the ileal bile acid transporter (IBAT), which lowers bile acid reabsorption and may help reduce the itch signal.

The recommended dose is Lynavoy 40mg tablet taken twice daily. Swallow tablets whole at least 30 minutes before any food or beverage (other than water).

Lynavoy should not be used in people with severe liver disease (decompensated cirrhosis), or people who have or have had certain liver-related problems including bleeding of enlarged blood vessels in the stomach-area (variceal hemorrhage), fluid in the stomach-area (ascites), or nervous system problems (such as confusion, slurred speech, sluggish movements) caused by severe liver disease (hepatic encephalopathy).

Lynavoy FDA approval was granted on March 17, 2026, to GlaxoSmithKline.

• Liver test elevations can occur. Baseline ALT, AST, total bilirubin, direct bilirubin, and alkaline phosphatase should be obtained and monitored during treatment. If liver test elevation persists, Lynavoy may need to be discontinued.
• Diarrhea is the most common adverse reaction. Patients should monitor for dehydration; treatment interruption or discontinuation may be needed if diarrhea persists.
• Lynavoy may reduce absorption of fat-soluble vitamins (A, D, E, and K). Monitor levels during treatment and for clinical indications of FSV deficiency. Supplement if FSV deficiency is diagnosed, and consider stopping treatment if deficiency persists or worsens despite FSV supplementation.
• Bleeding may occur in the setting of fat-soluble vitamin deficiency.
• Bone fractures have been associated with IBAT inhibitors; bone health monitoring is advised.

Tell your doctor or healthcare provider:

• if you have liver problems, especially cirrhosis, or if you have ever had hepatic decompensation events.
• if you have ongoing diarrhea, bleeding problems, or signs of vitamin deficiency.
• about all medicines you take, especially bile acid-binding resins.

Pregnancy

Tell your healthcare providers if you are pregnant or planning to become pregnant, as it is not known if Lynavoy will harm your unborn baby. There is a pregnancy safety study that monitors pregnancy outcomes in women who become pregnant while using this medicine. The purpose of this study is to collect information about your health and your baby’s health. If you are pregnant and exposed to Lynavoy, you or your healthcare provider should report your Lynavoy exposure by contacting Intercept Pharmaceuticals at 1-844-782-4278.

Breastfeeding

Tell your healthcare providers if you are breastfeeding or plan to breastfeed, as it is not known if Lynavoy passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using this medicine.

Most common side effects

The most common side effects of Lynavoy are diarrhea, headache, stomach pain, bleeding, nausea, dizziness, joint pain, high liver tests, indigestion, acid reflux, and bloating.

The GLISTEN Phase III trial (NCT04950127), a 24-week placebo-controlled study, the most common adverse reactions occurring in at least 5% of patients treated with Lynavoy and more often than placebo were the following:

Treatment discontinuation due to adverse reactions occurred more often with Lynavoy than placebo (14% vs 5%). The most common reasons for stopping treatment were diarrhea, abdominal pain, ALT increase, and AST increase.

Other clinically relevant safety information

• Fat-soluble vitamin deficiency was reported during treatment and should be monitored.

Serious side effects

Lynavoy may cause serious side effects, including increased liver enzymes, diarrhea, and fat-soluble vitamin (FSV) deficiency. See the Warnings and Important Information section for more details about these side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Recommended Lynavoy dosage: 40 mg by mouth twice daily.
• Take tablets whole at least 30 minutes before any food or beverage other than water.
• Hepatic impairment: Recommended dosage in mild hepatic impairment (Child-Pugh A) is the normal recommended dosage. Avoid use in patients with decompensated cirrhosis or prior/active hepatic decompensation; moderate and severe hepatic impairment with decompensation has not been adequately evaluated.
• Missed dose: take it as soon as possible and at least 30 minutes before your next meal, then resume the regular schedule. If more than 6 hours have passed, skip the dose and resume the usual schedule. Do not take 2 doses at the same time.
• With bile acid binding resins: take Lynavoy at least 4 hours before or 4 hours after the resin.

Formulation

Lynavoy 40mg tablets are supplied in bottles of 60 tablets (NDC 69516-140-60).

Tablets are purple, biconvex, round, film-coated tablets debossed with "GS 3JG" on one side.

In Study 1 (GLISTEN, NCT04950127), adults with PBC treated with Lynavoy had a greater reduction in itch severity over 24 weeks than those given a placebo.

The average monthly itch score improved by 2.86 points with Lynavoy versus 2.15 points with placebo, for a statistically significant treatment difference of -0.72 points (95% CI, -1.15 to -0.28; p=0.001). Improvement was also seen early, with significantly better weekly itch scores by Week 2 (LS mean difference -0.71; 95% CI, -1.07 to -0.34; p<0.001).

Drugs may interact with Lynavoy, including prescription and over-the-counter medicines, vitamins, and herbal products.

Tell your health care provider if you take medicines called bile acid-binding resins such as cholestyramine and colesevelam. Bile acid-binding resins must be taken at least 4 hours before or 4 hours after administration of Lynavoy

Not all possible drug interactions are listed here.

• Store at room temperature between 20 °C and 25°C (68° to 77°F), in the original package to protect from moisture.
• Keep the bottle tightly closed.
• Lynavoy bottles contain a desiccant canister (drying agent) to help keep the medicine dry. Do not remove or swallow the desiccant canister.

Lynavoy is a trademark of GSK Group of Companies licensed to Intercept Pharmaceuticals, Inc.Manufactured for:Intercept Pharmaceuticals, Inc., a wholly owned subsidiary of Alfasigma S.p.A. Morristown, NJ 07960

Active ingredients: linerixibat 40 mg Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Tablet film-coating: black iron oxide, hypromellose, polyethylene glycol, red iron oxide, and titanium dioxide.