Resmetirom

Hepatotoxicity
: Hepatotoxicity has been observed with use of Fibrocon. Monitoring of patient is required during treatment with Fibrocon for elevations in liver tests, for the development of liver-related adverse reactions and for sign & symptoms of hepatotoxicity. If hepatotoxicity is suspected, Fibrocon should be discontinued and monitoring of the patient should be continued. If laboratory values return to baseline, the potential risks against the benefits of restarting Fibrocon should be considered. If laboratory values do not return to baseline, DI-ALH or autoimmune liver disease should be considered in the evaluation of elevations in liver tests.
Gallbladder-Related Adverse Reactions
: In clinical trials, cholelithiasis, acute cholecystitis, and obstructive pancreatitis (gallstone) were observed in Fibrocon-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated , If an acute gallbladder event is suspected, Fibrocon treatment
should be interrupted until the event is resolved.
Drug Interaction with Certain Statins
: An increase in exposure of Atorvastatin, Pravastatin, Rosuvastatin and Simvastatin was observed when concomitantly administered with Fibrocon, which may increase the risk of adverse reactions related to these drugs. Dosage adjustment for certain statins is recommended.