Source: FDA, National Drug Code (US) Revision Year: 2026
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) [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
The recommended dosage of LYNAVOY is 40 mg orally twice daily. Swallow tablets whole at least 30 minutes before any food or beverage (other than water) [see Clinical Pharmacology (12.3)].
If a dose is missed, take the missed dose as soon as possible and at least 30 minutes before your next meal, then resume the original dosing schedule. If a dose is missed by more than 6 hours, skip the dose and resume the original dosing schedule. Do not take a double dose to make up for a missed dose.
Administer LYNAVOY at least 4 hours before or 4 hours after taking a bile acid binding resin [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Dose-dependent increases in the incidence of gastrointestinal adverse reactions have been observed with LYNAVOY dosages 4.5-fold higher than the recommended dosage.
There is no specific antidote for LYNAVOY. If an overdose occurs, discontinue LYNAVOY, monitor the patient for any signs and symptoms and institute general supportive measures as needed. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
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) [see USP Controlled Room Temperature].
Store in the original package to protect from moisture. Keep the bottle tightly closed.
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