瑞司美替罗100mg 瑞司美替罗是一种甲状腺激素受体-β (THR-β) 激动剂，与饮食和运动结合用于治疗患有中度至晚期肝纤维化（符合F2至F3期纤维化）的非肝硬化非酒精性脂肪性肝炎 (NASH) 的成年人。

LuciRes simple instructions

Please use under the guidance of a physician

Product Name: LuciRes

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Resmetiro Tablets

English name: Resmetirom tablet

Drug approval number: 09 L 1196/24 (100mg)

 

【Indications】

LuciRes is a thyroid hormone receptor-β (THR-β) agonist indicated, along with diet and exercise, for the treatment of adult patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis (meeting F2 to F3 fibrosis).

Limitation of Use

Avoid use of LuciRes in patients with decompensated cirrhosis.

 

【Usage and Dosage】

• The recommended dose of LuciRes is based on actual body weight. For patients weighing:

<100 kg: the recommended dose is 80 mg orally once daily.

For patients weighing ≥100 kg, the recommended dose is 100 mg orally once daily.

LuciRes may be taken with or without food.

• Please see full prescribing information for dose adjustments when LuciRes is used concomitantly with moderate CYP2C8 inhibitors.

 

【Specification】

100mg×30 tablets

 

【 Contraindications 】

none.

 

【 Warnings and precautions 】

• Hepatotoxicity: Monitor patients for elevated liver function markers and liver-related adverse reactions during treatment with LuciRes. If hepatotoxicity is suspected, discontinue LuciRes and continue to monitor the patient.

• Gallbladder-Related Adverse Reactions: Gallstones and cholecystitis occurred more frequently in patients treated with LuciRes. If gallstones are suspected, diagnostic gallbladder studies and appropriate clinical follow-up are warranted. If an acute gallbladder event (e.g., acute cholecystitis) is suspected, interrupt LuciRes therapy until the event resolves.

 

【Adverse Reactions】

The most common adverse reactions with LuciRes (reported by at least 5% of patients and more often than with placebo) were: diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness.

 

【Drug Interactions】

• Strong or moderate CYP2C8 inhibitors: Concomitant use is not recommended (strong inhibitors [e.g., gemfibrozil]); or LuciRes dose reduction (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 dose of statins as recommended.

• CYP2C8 Substrates: Monitor patients more frequently for substrate-related adverse reactions.

 

【Use by specific groups】

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

 

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.