Linerixibat

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

Linerixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids in the terminal ileum leading to their increased fecal elimination. Cholestatic pruritus is a common symptom in patients with PBC, and the pathophysiology of pruritus in patients with PBC is not completely understood. Although the complete mechanism by which linerixibat improves pruritus in PBC patients is unknown, it may involve inhibition of the IBAT as observed by a decrease in mediators of pruritus including serum bile acids.

The recommended dosage of LYNAVOY is 40 mg taken orally twice daily. Swallow tablets whole at least 30 minutes before any food or beverage (other than water).

None. None.

Liver Test Elevations: Obtain baseline liver tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin [TB], direct bilirubin [DB], alkaline phosphatase [ALP]) and monitor the levels per standard clinical practice during treatment. If new liver test elevations occur, monitor ALT, AST, TB, DB, and ALP more frequently. For persistent liver test elevations, discontinue LYNAVOY. Diarrhea: Diarrhea may occur. Advise patient to monitor for dehydration. Treatment interruption or discontinuation may be required if diarrhea persists. Fat-Soluble Vitamin (FSV) Deficiency: Obtain baseline levels and monitor during treatment. Supplement with FSV if deficiency is observed. If FSV deficiency persists or worsens despite FSV supplementation, consider permanent discontinuation of treatment. Bleeding: Interrupt treatment with LYNAVOY if bleeding occurs.

The following clinically significant adverse reactions are described elsewhere in labeling: Liver Test Elevations Diarrhea Fat-Soluble Vitamin Deficiency 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.

Bile Acid Binding Resins: Administer at least 4 hours before or 4 hours after administration of LYNAVOY. Effects of Bile Acid Binding Resins on LYNAVOY Instruct patients to take LYNAVOY at least 4 hours before or 4 hours after taking a bile acid binding resin. Based on in vitro data, bile acid resins may bind linerixibat in the gut. Concomitant use of bile acid binding resins with LYNAVOY can potentially inhibit the effects of LYNAVOY on the ileal bile acid transporter (IBAT).

Store at 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C to 30°C (59°F to 86°F). Store in the original package to protect from moisture.