Adult dose and durationDosed by actual body weight, taken once daily. Per the US label: below 100 kg the dose is 80 mg by mouth once daily, and at 100 kg or above it is 100 mg once daily. It can be taken with or without food; swallow tablets whole - they must not be divided, crushed or chewed. Combined with a moderate CYP2C8 inhibitor - clopidogrel is the label's example - dosing drops to 60 mg once daily under 100 kg and 80 mg once daily at 100 kg or above. StatPearls gives the same two weight-based doses. - Long-term, on an approval that is itself provisional. US label verbatim: "This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials." Liver tests are monitored throughout rather than checked once.
Paediatric doseNot a paediatric prescription. US label verbatim: "The safety and effectiveness of REZDIFFRA have not been established in pediatric patients."
Dose sourceREZDIFFRA (resmetirom) tablets US prescribing information, section 1 Indications and Usage, section 2 Dosage and Administration, section 5 Warnings and Precautions and section 8 Use in Specific Populations (DailyMed SetID e67ea09f-a840-439c-86c8-f98585f978b2)
WhyStatPearls names the drug, the fibrosis stage and the dose. Resmetirom, a thyroid hormone receptor-beta agonist, is licensed for MASH with F2-F3 fibrosis in patients who have not achieved significant weight loss; people with cirrhosis were excluded from the pivotal trials, and safety in that group is still under study. The doses given are 80 mg once daily under 100 kg and 100 mg once daily at 100 kg or above. The US label's indication matches the same disease and stage: adults with noncirrhotic MASH and moderate-to-advanced fibrosis (stage F2-F3), used alongside diet and exercise. It is the only drug licensed for MASH itself, rather than for the metabolic disease driving it, and the card carried none. Egypt has no registered resmetirom product, so no local brand or price can be shown; the row exists so a prescription started abroad can be recognised, with the fibrosis stage that gates it clearly stated.
Cautions- It is not for cirrhosis, and that is the boundary the whole row turns on. US label verbatim: "Avoid use of REZDIFFRA in patients with decompensated cirrhosis (consistent with moderate to severe hepatic impairment)." and "The safety and effectiveness of REZDIFFRA have not been established in patients with MASH cirrhosis." A patient with ascites, varices or a low platelet count needs hepatology, not this tablet.
- RED FLAG - it can itself injure the liver. US label verbatim: "Hepatotoxicity has been observed with use of REZDIFFRA." and "Monitor patients during treatment with REZDIFFRA for elevations in liver tests and for the development of liver-related adverse reactions. Monitor for symptoms and signs of hepatotoxicity (e.g., fatigue, nausea, vomiting, right upper quadrant pain or tenderness, jaundice, fever, rash, and/or eosinophilia [>5%]). If hepatotoxicity is suspected, discontinue REZDIFFRA and continue to monitor the patient." One reported case reached 58 times the upper limit of normal for ALT.
- Gallstones and their complications. US label verbatim: "In clinical trials, cholelithiasis, acute cholecystitis, and obstructive pancreatitis (gallstone) were observed more often in REZDIFFRA-treated patients than in placebo-treated patients. If an acute gallbladder event is suspected, interrupt REZDIFFRA treatment until the event is resolved."
- It raises statin levels, and most of these patients are on one. US label verbatim: "An increase in exposure of atorvastatin, pravastatin, rosuvastatin and simvastatin was observed when concomitantly administered with REZDIFFRA, which may increase the risk of adverse reactions related to these drugs. Dosage adjustment for certain statins is recommended. Monitor for statin-related adverse reactions including but not limited to elevation of liver tests, myopathy, and rhabdomyolysis."
- Two drug groups the disease article singles out. Resmetirom is not to be given with an OATP 1B1/1B3 inhibitor - ciclosporin is the example it gives - nor with a strong CYP2C8 inhibitor such as gemfibrozil. The label takes the same line on gemfibrozil, advising against REZDIFFRA alongside a strong CYP2C8 inhibitor.
- It does not replace the weight loss. The label ties it to diet and exercise, and the article frames it as being for MASH where significant weight loss has not happened - the patient who can lose 7% of body weight does not need it.
Egyptian brandsNo Egyptian brand matched — prescribe by generic name.