- Resmetirom is a specialty medication, first in class for NASH treatment, released in 2024
- Expensive at time of release ($4000/month) in 2024
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Nonalcoholic Steatohepatitis (NASH, MASH)
- Refractory to lifestyle and comorbidity management and moderate to severe Hepatic Fibrosis
- Decompensated Cirrhosis
- Moderate to severe hepatic imapirment (Child-Pugh Class B or C)
- Activates hepatic Thyroid Hormone Receptor Beta (THR-B Agonist)
- Increases hepatic Fat Metabolism and decreases hepatic fat deposition
- Resmetirom 60 mg, 80 mg, 100 mg
- Weight <100 kg: Resmetirom 80 mg orally once daily
- Weight >100 kg: Resmetirom 100 mg orally once daily
- Gastrointestinal (common)
- Diarrhea
- Nausea
- Acute Gallbladder dysfunction (uncommon)
- Includes Cholelithiasis, Cholecystitis, Gallstone Pancreatitis
- Hepatotoxicity
- Monitor Liver Function Tests
- Monitor for hepatotoxicity signs (Nausea, Vomiting, RUQ Abdominal Pain, Jaundice)
- Unknown safety in pregnancy
- Unknown safety in Lactation
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Statins
- Resmetirom increases Statin plasma concentrations
- Limit Simvastatin to 20 mg/day
- Limit Rosuvastatin to 20 mg/day
- Limit Pravastatin to 40 mg/day
- Limit Atorvastatin to 40 mg/day
- Moderate to Strong CYP2C8 Inhibitors
- Avoid strong CYP2C8 Inhibitors (e.g. Gemfibrozil) in combination with Resmetirom
- Moderate CYP2C8 Inhibitor (e.g. cloipidogrel)
- Weight <100 kg: Limit Resmetirom dose to 60 mg
- Weight >100 kg: Limit Resmetirom dose to 80 mg
- OATP1B1 and OATP1B3 Inhibitors (e.g. Cyclosporine)
- Avoid in combination with Resmetirom
- Resolves NASH with Fibrosis after 12 months of use when combined with diet and Exercise (NNT 6)
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