HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use LuciRes safely and effectively. See full prescribing information for LuciRes.

INDICATIONS AND USAGE

LuciRes is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). 

Limitations of Use

Avoid use of LuciRes in patients with decompensated cirrhosis.

DOSAGE AND ADMINISTRATION 

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

<100 kg, the recommended dosage is 80 mg orally once daily. 

≥100 kg, the recommended dosage is 100 mg orally once daily. 

Administer LuciRes with or without food. 

• See full prescribing information for LuciRes dosage modifications with concomitant use of moderate CYP2C8 inhibitors. 

DOSAGE FORMS AND STRENGTHS 

Tablets:  80 mg×30 tablets

CONTRAINDICATIONS 

None.

WARNINGS AND PRECAUTIONS 

• Hepatotoxicity: Monitor patients during treatment with LuciRes for elevations in liver tests and for the development of liver-related adverse reactions. Discontinue LuciRes and continue to monitor the patient if hepatotoxicity is suspected.

• Gallbladder-Related Adverse Reactions: Cholelithiasis and cholecystitis were observed more often in LuciRes-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies 

and appropriate clinical follow-up are indicated. If an acute gallbladder event such as acute cholecystitis is suspected, interrupt LuciRes treatment until the event is resolved.

ADVERSE REACTIONS 

The most common adverse reactions with LuciRes (reported in at least 5% of patients and higher compared to placebo) are: diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness. 

DRUG INTERACTIONS 

• Strong or Moderate CYP2C8 Inhibitors: Concomitant use not recommended (strong inhibitor [e.g., gemfibrozil]); or reduce LuciRes dosage (moderate inhibitor [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 the statin as recommended. 

• CYP2C8 Substrates: Monitor patients more frequently for substraterelated adverse reactions. 

USE IN SPECIFIC POPULATIONS 

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

Storage 

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.