A Supplement to
Volume 2 • 2025
A Supplement to
In conjunction with diet and exercise
The first and only FDA-approved treatment for adults with noncirrhotic NASH with moderate to advanced fibrosis This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Hepatology Insights
NASH=nonalcoholic steatohepatitis.
IMPORTANT SAFETY INFORMATION AND INDICATION
WARNINGS AND PRECAUTIONS Hepatotoxicity Hepatotoxicity has been observed in one patient. Please see full Prescribing Information for more details on this specific case of Hepatotoxicity [see Warnings and Precautions (5.1)].
Monitor patients during treatment 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. If laboratory values return to baseline, weigh the potential risks against the benefits of restarting Rezdiffra. If laboratory values do not return to baseline, consider DI-ALH or autoimmune liver disease in the evaluation of elevations in liver tests.
Please see additional Important Safety Information on the following pages.
IMPORTANT SAFETY INFORMATION (cont.) USE IN SPECIFIC POPULATIONS (cont.) Hepatic Impairment Avoid use in patients with decompensated cirrhosis (consistent with moderate to severe hepatic impairment). Moderate or severe hepatic impairment (Child-Pugh Class B or C) increases resmetirom Cmax and AUC, which may increase the risk of adverse reactions. No dosage adjustment is recommended for patients with mild hepatic impairment (Child-Pugh Class A). The safety and effectiveness have not been established in patients with NASH cirrhosis. INDICATION Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitation of Use: Avoid use in patients with decompensated cirrhosis.
Please see full Prescribing Information in pocket or visit www.madrigalpharma.com/Rezdiffra-USPI. © 2024 Madrigal Pharmaceuticals, Inc. All rights reserved. US-PP-RES-00098-v2-GE 06/24 Rezdiffra™ and its related logo are trademarks of Madrigal Pharmaceuticals, Inc.
Study Finds 3 in 4
Overweight, Obese Adults Have Steatotic Liver Disease Visit RezdiffraHCP.com to learn more and get patients started.
Reports From The Liver Meeting, Advanced ALD Review, New Resmetirom Analyses and More