Frehepta(Resmetirom)
Therapeutic Group: Hormone replacement therapy
Presentation
Frehepta™ 60 tablet: Each tablet contains Resmetirom INN 60 mg.
Frehepta™ 80 tablet: Each tablet contains Resmetirom INN 80 mg.
Frehepta™ 100 tablet: Each tablet contains Resmetirom INN 100 mg.
Description
Resmetirom is a thyroid hormone receptor-beta agonist (THR-?). THR-? is the major form of thyroid hormone receptor in the liver, and stimulation of THR-? in the liver reduces intrahepatic triglycerides.
Indications
Resmetirom is a prescribed medicine to treat adults with metabolic dysfunction asscociated steatohepatitis (MASH) formerly known as nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis grade 2-3).
Dosage & Administration
The recommended dosage is based on actual body weight. According to the weight of the patients, the dosage will be-
<100 kg, the recommended dosage is 80 mg orally once daily
?100 kg, the recommended dosage is 100 mg orally once daily
Dosage modifications for patients already taking CYP2C8 Inhibitors(clopidogrel, montelukast and clotrimazole)-
<100 kg, reduce the dosage of Resmetirom to 60 mg once daily
?100 kg, reduce the dosage of Resmetirom to 80 mg once daily.
Atorvastatin, Pravastatin, Rosuvastatin and Simvastatin: Limit the daily dosage.
Rosuvastatin/Simvastatin: Max 20 mg/day, Pravastatin/Atorvastatin: Max 40 mg/day
Concomitant use with strong CYP2C8 inhibitor (Gemfibrozil) and OATP1B1/1B3 inhibitors (e.g., cyclosporine) is not recommended.
Administer resmetirom with or without food.
Side Effects
Resmetirom might cause diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness etc.
Precautions
Patients with hepatotoxicity & gallbladder-related adverse reactions (Cholelithiasis and cholecystitis) should use Resmetirom cautiously.
Use in Pregnancy & Lactation
If needed it can be used in pregnant or lactating mothers after consultation with a health care professional.
Drug Interaction
Dosage modifications for patients already taking CYP2C8 Inhibitors (clopidogrel, montelukast and clotrimazole)-
<100 kg, reduce the dosage of Resmetirom to 60 mg once daily
≥100 kg, reduce the dosage of Resmetirom to 80 mg once daily.
Concomitant use with strong CYP2C8 inhibitor (Gemfibrozil) and OATP1B1/1B3 inhibitors (e.g., cyclosporine) is not recommended.
Atorvastatin, Pravastatin, Rosuvastatin and Simvastatin: Limit the daily dosage.
CYP2C8 Substrates: Monitor patients more frequently for substrate-related adverse reactions.
Commercial Pack
Frehepta™ 60 tablet: Each box contains 3 blister strips of 10 tablets.
Frehepta™ 80 tablet: Each box contains 3 blister strips of 10 tablets.
Frehepta™ 100 tablet: Each box contains 3 blister strips of 10 tablets.