Remeliv^®

Remeliv ® is a preparation of Resmetirom which is a partial agonist of the thyroid hormone receptor-beta (THR-β). THR-β is the major form of THR in the liver and stimulation of THR-β in the liver reduces intrahepatic triglycerides. Moreover, actions of thyroid hormone outside the liver, including in heart and bone are largely mediated through THR-α

No Data

Remeliv ® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.

Route of administration: Remeliv ® should be taken in oral route with or without food. The recommended dosage of Remeliv  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.

Hepatic impairment
Remeliv should be avoided in patients with decompensated cirrhosis (consistent with moderate to severe hepatic impairment). Moderate or severe hepatic impairment (Child- Pugh Class B or C) increases resmetirom C max and AUC of Remeliv ®, which may increase the risk of adverse reactions. The safety and effectiveness of Remeliv ® have not been established in patients with NASH cirrhosis

Pregnancy: There are no well controlled studies of pregnant women exposed to resmetirom of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Resmetirom should be avoided during pregnancy.

Lactation: There is no information on the effects of resmetirom on milk production. The developmental and health benefits of breastfeeding should be considered along with the
mother’s clinical need for resmetirom and any potential adverse effects on the breastfed child from resmetirom or from the mother’s underlying condition.

Use in children and adolescents
The safety and efficacy of resmetirom in children and adolescents have not been established

Patients should be monitored during treatment for changes in liver function tests and for symptoms and signs of hepatotoxicity. If hepatotoxicity is suspected, resmetirom administration should be discontinued. Cholelithiasis, acute cholecystitis and obstructive pancreatitis are observed more often in resmetirom treated patients. Caution should be taken

The most common side effects are diarrhea, itching, vomiting, constipation, nausea, abdominal pain and dizziness

It is contraindicated in patients with history of known hypersensitivity to resmetirom or any other components of this product

Drug interaction with medication: Concomitant use of resmetirom with strong CYP2C8 inhibitors and with OATP1B1 or OATP1B3 inhibitors is not recommended. Resmetirom dosage
should be reduced if used concomitantly with a moderate CYP2C8 inhibitor as such:
If patient’s weight is <100 kg, the dosage of resmetirom should be reduced to 60 mg once daily.
If patient’s weight is ≥100 kg, the dosage of resmetirom should be reduced to 80 mg once daily.

Concomitant use of resmetirom with some statins (atorvastatin, pravastatin, rosuvastatin and simvastatin) may increase the risk of adverse reactions related to these drugs as resmetirom increases plasma concentrations of the drugs. So dosage adjustment is necessary as such:
Rosuvastatin and simvastatin: Limit daily statin dosage to 20 mg.
Pravastatin and atorvastatin: Limit daily statin dosage to 40 mg.

Drug interaction with food and others: Not applicable.

In the event of overdose, supportive care including close medical supervision and monitoring should be provided.

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Remeliv 60 tablet: Each coated tablet contains Resmetirom INN 60 mg.
Remeliv 80 tablet: Each coated tablet contains Resmetirom INN 80 mg.
Remeliv 100 tablet: Each coated tablet contains Resmetirom INN 100 mg

Storage
Store below 25°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Remeliv 60 tablet: Carton of 10 tablets in blister pack.
Remeliv 80 tablet: Carton of 10 tablets in blister pack.
Remeliv 100 tablet: Carton of 10 tablets in blister pack