Resmetirom is a thyroid hormone receptor-beta (THR-β) agonist which is the first & only US FDA approved diseases specific oral therapy indicated for the treatment of NASH/MASH with fibrosis (stages F2 to F3). It works directly in the liver by stimulating THR-β to improve critical hepatic processes and reduce fibrosis.
Resmetirom is a thyroid hormone receptor-beta (THR-β) agonist which is the first & only US FDA approved diseases specific oral therapy indicated for the treatment of NASH/MASH with fibrosis (stages F2 to F3). It works through multiple pathways and where it works directly in the liver by stimulating THR-β to improve critical hepatic processes and reduce fibrosis. Resmetirom stimulates THR-β signaling, regulating the expression of genes that improve critical processes in the liver, such as lipid metabolism and mitochondrial biogenesis. Thus, Resmetirom slows down the disease progression, reduces liver damage and improves liver health. Different clinical trials show that Resmetirom ensures broad response rate in NASH treatment & also ensures a favorable cardiovascular profile by reducing serum lipid profile.
Livheal 80 mg Tablet: Each film coated tablet contains Resmetirom INN 80 mg.
Livheal 100 mg Tablet: Each film coated tablet contains Resmetirom INN 100 mg.
Livheal is 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).
The recommended dosage of Livheal 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 Livheal with or without food.
Dosage Modifications for CYP2C8 Inhibitors Concomitant use of Livheal with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended. If Livheal is used concomitantly with a moderate CYP2C8 inhibitor (e.g., Clopidogrel), reduce the dosage of Livheal:
● <100 kg, reduce the dosage of Livheal to 60 mg once daily.
● ≥100 kg, reduce the dosage of Livheal to 80 mg once daily.
Overdosage: There is no information regarding the acute toxicity and overdosage of resmetirom
None
Hepatotoxicity: Monitor patients during treatment with Resmetirom for elevations in liver tests and for the development of liver-related adverse reactions. Discontinue Resmetirom and continue to monitor the patient if hepatotoxicity is suspected. Gallbladder-Related Adverse Reactions: Cholelithiasis and cholecystitis were observed more often in Resmetirom- 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 Resmetirom treatment until the event is resolved.
The most common side effects with Resmetirom are diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness. Diarrhea and nausea were the most common causes of treatment discontinuation.
Strong or Moderate CYP2C8 Inhibitors: Concomitant use not recommended (strong inhibitor [e.g., Gemfibrozil]); or reduce Resmetirom dosage (moderate inhibitor [e.g., Clopidogrel]).
OATP1B1 and OATP1B3 Inhibitors: Concomitant use with OATP inhibitors (e.g., Cyclosporine) is not recommended.
Statins: Limit daily Rosuvastatin and Simvastatin dosage to 20 mg. Limit Pravastatin and Atorvastatin dosage to 40 mg.
CYP2C8 Substrates: Monitor patients more frequently for substrate related adverse reactions.
Pregnancy: There are no available data on Resmetirom use in pregnant women. Lactation: There is no information regarding the presence of Resmetirom in human or animal milk, the effects on the breast-fed infant, or the effects on milk production. Geriatric Use: Numerically higher incidence of adverse reactions have been observed in patients ≥65 years of age compared to younger adult patients. Renal Impairment: Resmetirom has not been studied in patients with severe renal impairment. Hepatic Impairment: Avoid use in patients with decompensated cirrhosis (consistent with moderate to severe hepatic impairment). Moderate or severe hepatic impairment (Child-Pugh Class B or C) may increase the risk of adverse reactions. The safety and effectiveness have not been established in patients with cirrhosis.
Livheal 80 mg Tablet: Each box contains 20 Tablets in alu-alu blister pack.
Livheal 100 mg Tablet: Each box contains 10 Tablets in alu-alu blister pack.
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