Healthcare Professionals

Indications

ReMASH™ is indicated for use in conjunction with diet and exercise to treat adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and moderate to advanced hepatic fibrosis (F2–F3), confirmed by histologic or imaging assessment.

It is not indicated for patients with cirrhosis or decompensated liver disease.

Mechanism of Action

Resmetirom is a selective thyroid hormone receptor beta (THR-β) agonist that targets the liver. By activating THR-β, ReMASH™ enhances mitochondrial activity and reduces lipotoxicity in hepatocytes, leading to: 

• Reduction of hepatic steatosis
• Suppression of liver inflammation
• Improvement in fibrosis markers
• Enhanced lipid metabolism (↓ LDL-C, ↓ triglycerides, ↓ ApoB)

Dosing & Administration

• Recommended starting dose: 80mg or 100mg once daily, based on patient’s weight and tolerability
• Administer orally, with or without food
• Tablets should be swallowed whole, not crushed or split
• Dosing adjustments not required in mild to moderate renal impairment

How to Use

• Take orally once a day at a consistent time
• Can be co-administered with statins, insulin, or antidiabetic medications
• Not recommended in combination with gemfibrozil or cyclosporine

Precautions and Warnings

• Liver Injury: Monitor ALT, AST, and bilirubin prior to initiation and during therapy. Discontinue if signs of hepatotoxicity develop.
• Gallbladder Disease: Use with caution in patients with pre-existing gallstones or gallbladder dysfunction.
• Thyroid Axis Disturbance: Although ReMASH™ is liver-selective, monitor TSH and free T3 in patients with thyroid dysfunction.
• Use in Pregnancy: Not recommended. Teratogenicity has not been ruled out.

Drug Interactions

Avoid concomitant use with

• Gemfibrozil: May significantly increase resmetirom levels
• Cyclosporine: Can alter metabolism, leading to adverse effects Use with caution:
• Clopidogrel and statins: Adjust doses based on tolerability
• CYP3A4 inducers may reduce efficacy
• Bile acid sequestrants may reduce absorption

Monitoring Recommendations

• Baseline and periodic LFTs
• Fibrosis progression via imaging (MRI-PDFF or FibroScan) every 6-12 months
• Lipid profile: LDL-C, triglycerides, ApoB
• HbA1c and fasting glucose in patients with metabolic comorbidities
• Monitor for signs of gallbladder dysfunction

Features and Clinical Details

• First and only oral FDA-approved therapy for MASH with fibrosis (F2-F3)
• Targets the root pathophysiology-hepatic steatosis and lipotoxicity
• Demonstrated fibrosis improvement in Phase 3 trials (≥1 stage reduction in ~26-30% patients)
• Improves cardiovascular risk profile by lowering LDL-C, triglycerides, and ApoB
• Does not cause weight gain; may support weight loss in some patients

Contraindications

• Known hypersensitivity to resmetirom or excipients
• Severe hepatic impairment (Child-Pugh C)
• Pregnancy and lactation (due to unknown fetal risk)

Long Term Risks

• Risk of hepatotoxicity with prolonged unmonitored use
• Potential for subclinical thyroid suppression or shift in lipid parameters
• Unclear effects in cirrhotic or end-stage liver patients-use not recommended

Patient Counselling Information

• Educate patients about signs of liver injury or gallbladder issues
• Reinforce the need for diet, weight loss, and exercise as part of treatment
• Discuss long-term commitment to therapy and importance of adherence
• Advise reporting of all new symptoms, especially abdominal pain or jaundice
• Encourage routine monitoring and follow-up for fibrosis and metabolic status

Product Presentation

• Tablets: 60mg, 80mg, and 100mg
• Storage: 20°C to 25°C (68°F to 77°F)
• Blister and bottle packs with moisture control