Lucires is a prescribed medicine used along with diet and exercise to treat adults with Noncirrhotic Non Alcoholic Steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. Avoid use of Lucires in patients with decompensated cirrhosis.

This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Do not use Lucires for a condition for which it was not prescribed. Do not give Lucires to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Lucires that is written for health professionals.

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.

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.

Treatment of adults with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

This indication is approved under accelerated approval based on improvement of NASH and fibrosis (Clinical Studies). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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).

Resmetirom is a partial agonist of the thyroid hormone receptor-beta (THR-β). Resmetirom produced 83.8% of the maximum response compared to triiodothyronine (T3), with an EC50 of 0.21 µM in an in vitro functional assay for THR-β activation. The same functional assay for thyroid hormone receptor alpha (THR-α) agonism showed 48.6% efficacy for Resmetirom relative to T3, with an EC50 of 3.74µM. THR-β is the major form of THR in the liver, and stimulation of THR-β in the liver reduces intrahepatic triglycerides, whereas actions of thyroid hormone outside the liver, including in heart and bone, are largely mediated through THR-α.

Take Lucires exactly as your healthcare provider tells you to take it.

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.

Hepatotoxicity

Tiredness

Fever

Pain or tenderness in the upper middle or upper right area of your stomach (abdomen)

Nausea

Rash

Vomiting

Your skin or the white part of your eyes turns yellow (jaundice)

Gallstones, or inflammation of the gallbladder, or inflammation of the pancreas

Diarrhea

Itching

Constipation

Dizziness

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 substrate related adverse reactions.

Store at 20 °C to 25°C (68 °F to 77°F).

Excursions permitted to 15 °C to 30°C (59° F to 86°F).

Before you take Lucires, tell your healthcare provider about your entire medical conditions, including if you:

• have any liver problems other than NASH.

• have gallbladder problems or have been told you have gallbladder problems, including gallstones.

• are pregnant or plan to become pregnant. It is not known if Lucires will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if Lucires passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Lucires.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Lucires is not recommended in patients taking these medicines.

Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.