RESTORAM
RESMETIROM · by HIGH-Q
Composition
Tab 60mg/80mg/100mg: Resmetirom 60mg/80mg/100mg
Indications & Dosage
Treatment of noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (stages F2 to F3 fibrosis): Adults: The recommended dosage is based on body weight: For <100 kg, 80 mg orally once daily; For ≥100 kg, 100 mg orally once daily. Children: Not recommended.
Administration
For IV infusion dilute in sterile 0.9 % sodium chloride solution. For stability, dilutions to concentration less than 2 mg iron/ml are not permissible. Test dose is not required
Contraindications
Hypersensitivity
Precautions
Concomitant use of Resmetirom with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended; with a moderate CYP2C8 inhibitor (e.g., clopidogrel), reduce the dosage of Resmetirom. Monitor for symptoms and signs of hepatotoxicity; if hepatotoxicity is suspected, discontinue Resmetirom. If an acute gallbladder event is suspected, interrupt Resmetirom treatment until the event is resolved. Avoid use of Resmetirom 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 Cmax and AUC, which may increase the risk of adverse reactions. No dosage adjustment is recommended for patients with mild hepatic impairment (Child-Pugh Class A).
Interactions
Strong or moderate CYP2C8 inhibitors, Statins (Atorvastatin, Pravastatin, Rosuvastatin, or Simvastatin).
Pregnancy
Not recommended
Lactation
Not recommended
Side Effects
Abdominal pain, hepatotoxicity, cholelithiasis, acute cholecystitis, obstructive pancreatitis (gallstone) and other gallbladder-related adverse reactions, diarrhea, nausea, pruritis.