Lucius Version of Resmetirom: Dosage and Administration, Indications, Precautions

Lucius Version of Resmetirom: Dosage and Administration, Indications, Precautions

Indications

Resmetirom is a thyroid hormone receptor-beta (THR-β) agonist. When used in combination with diet and exercise, it is indicated for the treatment of adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) who have moderate to advanced liver fibrosis (meeting the criteria for F2 to F3 stage fibrosis).

Usage Limitations

Avoid using Resmetirom in patients with decompensated cirrhosis.

Dosage and Administration

The recommended dosage of Resmetirom is based on actual body weight. For patients with the following body weights:

< 100 kg: The recommended dosage is 80 mg orally once daily.

≥ 100 kg: The recommended dosage is 100 mg orally once daily.

Resmetirom can be taken with or without food.

Refer to the full prescribing information for dosage adjustments of LuciRes when used concomitantly with moderate CYP2C8 inhibitors.

Use in Specific Populations

Hepatic Impairment: Avoid using LuciRes in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C).

Warnings and Precautions

Hepatotoxicity: During treatment with Resmetirom, monitor patients for elevated liver function markers and the occurrence of liver-related adverse reactions. If hepatotoxicity is suspected, discontinue LuciRes and continue monitoring the patient.

Gallbladder-Related Adverse Reactions: Patients receiving Resmetirom have a higher incidence of gallstones and cholecystitis. If gallstones are suspected, diagnostic studies of the gallbladder and appropriate clinical follow-up are required. If an acute gallbladder event (e.g., acute cholecystitis) is suspected, interrupt Resmetirom treatment until the event resolves.

Drug Interactions

Strong or Moderate CYP2C8 Inhibitors: Concomitant use is not recommended (for strong inhibitors [e.g., gemfibrozil]); or the dosage of LuciRes should be reduced (for moderate inhibitors [e.g., clopidogrel]).

OATP1B1 and OATP1B3 Inhibitors: Concomitant use with OATP inhibitors (e.g., cyclosporine) is not recommended.

Atorvastatin, Pravastatin, Rosuvastatin, and Simvastatin: Limit the daily dosage of statins as recommended.

CYP2C8 Substrates: More frequently monitor patients for the occurrence of substrate-related adverse reactions.

Contraindications

Not established.

Dosage Form

Tablets

Storage Method

Store at 20°C to 25°C (68°F to 77°F); short-term transportation between 15°C and 30°C (59°F and 86°F) is permitted. Protect from moisture.