Resmetirom has medicine-specific safety considerations involving the liver, gallbladder and drug interactions.
Hepatotoxicity
Current U.S. labeling warns about hepatotoxicity. Patients should be monitored for elevations in liver tests and liver-related adverse reactions. If hepatotoxicity is suspected, Rezdiffra should be discontinued and the patient monitored according to the prescribing information.
Gallbladder-related reactions
Cholelithiasis and cholecystitis occurred more frequently in Rezdiffra-treated patients than in placebo-treated patients. If gallbladder disease is suspected, diagnostic evaluation and appropriate follow-up are indicated.
Statin interactions
Resmetirom interacts with several statins. Current U.S. labeling specifies dose limits for atorvastatin, pravastatin, rosuvastatin and simvastatin.
CYP2C8 interactions
Strong CYP2C8 inhibitors, such as gemfibrozil, are not recommended. Moderate inhibitors such as clopidogrel can require a lower resmetirom dose.
Hepatic impairment
The current U.S. label advises avoiding Rezdiffra in patients with moderate or severe hepatic impairment. It also states that Rezdiffra should be avoided in patients with decompensated cirrhosis.
Pregnancy and lactation
The official prescribing information should be consulted for the current pregnancy and lactation recommendations. Resiliva-specific labeling is Everest Pharmaceuticals Ltd.