Resmirom 60

Livheal tablet, in combination with appropriate diet and exercise, is indicated for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) associated with moderate to advanced liver fibrosis (corresponding to fibrosis stages F2–F3).

The recommended dose of Livheal is determined based on actual body weight:

Patients weighing <100 kg: 80 mg orally once daily

Patients weighing ≥100 kg: 100 mg orally once daily

Livheal may be taken with or without food.
রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

Drug Interactions

Effects of Other Drugs on Livheal

CYP2C8 Inhibitors:
Concomitant use of Livheal with strong or moderate CYP2C8 inhibitors may increase the risk of adverse reactions.

Use with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended.

If used with moderate CYP2C8 inhibitors (e.g., clopidogrel), dose reduction is required:

<100 kg: 60 mg once daily

≥100 kg: 80 mg once daily

OATP1B1 and OATP1B3 Inhibitors:
Co-administration with OATP1B1 or OATP1B3 inhibitors (e.g., cyclosporine) may increase Livheal exposure and the risk of adverse reactions; such combinations are not recommended.

Effects of Livheal on Other Drugs

Statins:
Livheal increases plasma concentrations of certain statins (atorvastatin, pravastatin, rosuvastatin, and simvastatin), potentially increasing statin-related adverse effects. Recommended maximum daily doses are:

Rosuvastatin and Simvastatin: 20 mg

Atorvastatin and Pravastatin: 40 mg

CYP2C8 Substrates:
Livheal may increase exposure to CYP2C8 substrates (e.g., pioglitazone). Patients should be closely monitored, particularly when small increases in substrate concentration may result in clinically significant adverse reactions.

Side Effects

Commonly reported adverse effects include diarrhea, nausea, vomiting, abdominal pain, dizziness, pruritus, and constipation.

Pregnancy & Lactation

Pregnancy:
There are no adequate data on the use of Resmetirom in pregnant women to assess the risk of major congenital anomalies, miscarriage, or adverse maternal or fetal outcomes.

Lactation:
There is no information regarding the presence of Resmetirom in human or animal milk, its effects on the breastfed infant, or its influence on milk production. The benefits of breastfeeding should be weighed against the mother’s clinical need for Livheal and any potential risks to the infant.

Precautions & Warnings

Hepatotoxicity:
Cases of hepatotoxicity have been reported with Livheal use. Patients should be monitored regularly for elevations in liver function tests and signs or symptoms of liver injury. If hepatotoxicity is suspected, treatment should be discontinued and monitoring continued. Re-initiation should be carefully considered after liver parameters return to baseline. Persistent abnormalities should prompt evaluation for drug-induced autoimmune-like hepatitis or autoimmune liver disease.

Gallbladder-Related Events:
Cholelithiasis, acute cholecystitis, and gallstone-related obstructive pancreatitis have been reported in clinical trials. If gallbladder disease is suspected, appropriate diagnostic evaluation and clinical management are required. Livheal therapy should be interrupted during acute gallbladder events until resolution.

Statin Interaction Warning:
Increased exposure to certain statins may occur during concomitant use with Livheal, necessitating dose adjustments to reduce the risk of adverse reactions.

Use in Special Populations

Pediatric Patients: Safety and efficacy have not been established.

Geriatric Patients: No overall differences in effectiveness were observed; however, a numerically higher incidence of adverse reactions has been reported in patients aged 65 years and older.

Renal Impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Livheal has not been studied in severe renal impairment.

Hepatic Impairment: Use in patients with decompensated cirrhosis or moderate to severe hepatic impairment (Child-Pugh Class B or C) should be avoided. No dose adjustment is required in mild hepatic impairment (Child-Pugh Class A).

Storage Conditions

Store below 30°C in a cool, dry place. Protect from light. Keep out of reach of children.