60mg/80mg/100mg*30 film-coated tablets

Indications

Remetiro is indicated, in combination with diet and exercise, for the treatment of adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) associated with moderate to advanced liver fibrosis (fibrosis stage equivalent to F2 to F3).

Mechanism of Action / Efficacy

Remetiro exerts its therapeutic effect through partial agonism of thyroid hormone receptor-beta (THR-β). THR-β is the predominant form of thyroid hormone receptor in the liver. Its activation in the liver significantly reduces intrahepatic triglyceride accumulation, thereby improving NASH-associated liver fibrosis. Notably, the effects of thyroid hormones outside the liver (e.g., in the heart and bone) are primarily mediated by THR-α. Therefore, Remetiro is designed to maximize liver-specific effects while minimizing systemic side effects.

Presentation/Strength

Remetiro is supplied as film-coated tablets in three strengths:

• 60mg tablet: White, oval-shaped

• 80mg tablet: Yellow, oval-shaped

• 100mg tablet: Beige to pink, oval-shaped

Dosage and Administration

• Dose: The recommended dosage is based on the patient's actual body weight and requires precise adjustment.

• Patients <100 kg: 80 mg taken orally once daily.

• Patients ≥100 kg: 100 mg taken orally once daily.

• Administration: Take orally once daily at the same time each day, without regard to meals (i.e., can be taken with or without food).

• Important: Take Remetiro exactly as prescribed by your doctor or pharmacist.

• Prior to starting treatment: Patients must inform their healthcare provider about all medications they are using (including prescription, over-the-counter medicines, vitamins, and herbal supplements) to avoid potential drug interactions.

Storage Conditions

Remetiro does not require any special storage conditions but must be handled as follows:

• Keep this medicine out of the sight and reach of children.

• Do not use after the expiry date, which is stated on the packaging and bottle label after "EXP" (refers to the last day of the month).

• Do not dispose of via wastewater or household waste. To protect the environment, consult your pharmacist for proper disposal methods for unused medicines.

Important Safety Information (Precautions)

• Contraindications: Hypersensitivity to resmetirom or to any of the excipients.

• Warnings and Precautions:

• Avoid concomitant use with strong CYP2C8 inhibitors (e.g., gemfibrozil) or OATP1B1/OATP1B3 inhibitors (e.g., cyclosporine).

• Reduce the dosage of Remetiro when used concomitantly with moderate CYP2C8 inhibitors (e.g., clopidogrel).

• Increased exposure to statins (e.g., atorvastatin) may occur, potentially leading to adverse reactions (e.g., myopathy, rhabdomyolysis). Monitor for statin-associated adverse effects.

• Risk of Hepatotoxicity: Monitor liver function tests (e.g., for elevated liver enzymes) and for symptoms suggestive of hepatic adverse reactions (e.g., fatigue, nausea, vomiting, right upper quadrant abdominal pain or tenderness, jaundice, fever, rash, and/or eosinophilia [>5%]). If hepatotoxicity is suspected, discontinue Remetro immediately and continue to monitor the patient. Consider restarting Remetiro only if laboratory values return to baseline after a careful evaluation of the benefits and risks. If values do not return to baseline, consider drug-induced liver injury (DILI) or autoimmune liver disease.

• Gallbladder-Related Problems: Patients with NASH may be at risk for gallbladder events (e.g., cholelithiasis, cholecystitis, or pancreatitis). If an acute gallbladder event is suspected, interrupt Remetiro treatment until the event resolves and perform diagnostic gallbladder imaging.

• Drug Interactions:

• Use in Specific Populations:

• Pregnancy and Lactation: There are no available data on the risk associated with Remetiro use in pregnant women or its presence in human milk and effects on the breastfed infant. Use is contraindicated during pregnancy. Women who are breastfeeding should consult their healthcare provider to choose the best feeding option.

• Pediatric Use: Safety and effectiveness have not been established in pediatric patients.

• Geriatric Use: No overall differences in effectiveness were observed between patients aged 65 years and older and younger patients. However, the incidence of adverse reactions was higher in patients ≥65 years.

• Renal Impairment: No dosage adjustment is required for patients with mild or moderate renal impairment. Remetiro has not been studied in patients with severe renal impairment.

• Hepatic Impairment: Avoid use in patients with decompensated cirrhosis (moderate or severe hepatic impairment, Child-Pugh B or C) due to a potential increased risk of adverse reactions. No dosage adjustment is required for patients with mild hepatic impairment (Child-Pugh A).

• Adverse Reactions:

• Most Common: Diarrhea, pruritus (itching), vomiting, constipation, nausea, abdominal pain, and dizziness.

• Serious: Hepatotoxicity (liver injury) and gallbladder problems (symptoms described above).

• Reporting: Patients should immediately report any side effects to their doctor or pharmacist.

Overall Reminder: Remetiro should be used under medical supervision. Patients should keep a list of all medicines they take and share this list with their healthcare provider. This medicinal product is subject to additional monitoring; reporting suspected adverse reactions after authorization helps gather more information on its safety profile.