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. Limitation of Use: Avoid use in patients with decompensated cirrhosis.
Wednesday, March 12, 2025
Thursday, March 13, 2025
Wednesday, March 12, 2025
7:00 PM ET • 6:00 PM CT
5:00 PM MT • 4:00 PM PT
Thursday, March 13, 2025
7:00 PM ET • 6:00 PM CT
5:00 PM MT • 4:00 PM PT
Wednesday, March 12, 2025
10:00 PM ET • 9:00 PM CT
8:00 PM MT • 7:00 PM PT
Thursday, March 13, 2025
10:00 PM ET • 9:00 PM CT
8:00 PM MT • 7:00 PM PT

Distinguished Faculty Panelists Include

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Naim Alkhouri, MD, FAASLD

Chief Medical Officer
Director, Steatotic Liver Program
Chief of Transplant Hepatology
Arizona Liver Health
Phoenix, AZ

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Nadege Gunn, MD, DABOM, CPI

Gastroenterology/Hepatology
Medical Director & Senior Scientific Advisor
Velocity Clinical Research
Adjunct Assistant Professor
Texas A & M College of Medicine
Hepatology Clinic Director, Coryell Health
Waco, TX

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Corrie Berk, DNP, MBA

Director
Hepatology & Transplant Outreach Programs
Transplant Hepatology Nurse Practitioner
The Texas Liver Institute
San Antonio, TX

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Anthony Martinez, MD, AAHIVS, FAASLD

Associate Professor of Medicine
Jacobs School of Medicine
University at Buffalo
Medical Director, Hepatology
Erie County Medical Center
Buffalo, NY

You will receive a unique URL to use on the day of the program.

DISCLOSURE

This promotional educational activity is not accredited. The program content is developed by Madrigal Pharmaceuticals, Inc. Speakers are being compensated for their time by Madrigal Pharmaceuticals, Inc., present on behalf of the company, and are required to present information in compliance with FDA requirements for communications about its medicine.

In adherence with PhRMA guidelines, spouses or other guests are not permitted to attend company-sponsored programs, unless spouse or other guest(s) independently qualify as an attendee.

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Please note that the company prohibits the offering of gifts, gratuities, or meals to federal government employees/officials. Thank you for your cooperation.

WARNINGS AND PRECAUTIONS

Hepatotoxicity

Hepatotoxicity has been observed with the use of Rezdiffra. One patient developed substantial elevations of liver biochemistries that resolved when treatment was interrupted. Please see full Prescribing Information for more details on this specific case of Hepatotoxicity [see Warnings and Precautions (5.1)].

Monitor for elevations in liver tests, liver-related adverse reactions, and symptoms/signs of hepatotoxicity (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness, jaundice, fever, rash, and/or eosinophilia [>5%]). If hepatotoxicity is suspected, discontinue Rezdiffra and monitor. 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 drug-induced autoimmune-like hepatitis (DI-ALH) or autoimmune liver disease in the evaluation of elevations in liver tests.

Gallbladder-Related Adverse Reactions

Cholelithiasis, acute cholecystitis, and obstructive pancreatitis (gallstone) were observed more often in Rezdiffra-treated patients than in placebo-treated patients. The exposure-adjusted incidence rates (EAIRs) for these events were less than 1 per 100 person-years (PY) for all treatment arms. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated. If an acute gallbladder event is suspected, interrupt treatment 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 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. Please see the upcoming Drug Interactions section of the Important Safety Information for more details.

ADVERSE REACTIONS

The most common adverse reactions with Rezdiffra (reported in ≥ 5% of patients and higher compared to placebo) are diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness. Diarrhea and nausea were the most common causes of treatment discontinuation.

DRUG INTERACTIONS

Clinically Significant Interactions Affecting Rezdiffra

  • Concomitant use with strong CYP2C8 inhibitors (eg, gemfibrozil) is not recommended. Reduce dosage if used concomitantly with a moderate CYP2C8 inhibitor (eg, clopidogrel).
  • Concomitant use with OATP1B1 or OATP1B3 inhibitors (eg, cyclosporine) is not recommended.

Clinically Significant Interactions Affecting Other Drugs

  • Statins: Limit daily rosuvastatin and simvastatin dosage to 20 mg. Limit pravastatin and atorvastatin dosage to 40 mg.
  • CYP2C8 Substrates: Monitor patients more frequently for substrate-related adverse reactions if Rezdiffra is co-administered with CYP2C8 substrates where minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no available data on Rezdiffra use in pregnant women. Report pregnancies to Madrigal Pharmaceuticals, Inc.'s Adverse Event reporting line at 1-800-905-0324 and https://www.madrigalpharma.com/contact/.

Lactation

There is no information regarding the presence of Rezdiffra in human or animal milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Rezdiffra and any potential adverse effects on the breastfed infant from Rezdiffra or from the underlying maternal condition.

Geriatric Use

Numerically higher incidence of adverse reactions have been observed in patients ≥65 years of age compared to younger adult patients.

Renal Impairment

Rezdiffra has not been studied in patients with severe renal impairment.

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) may increase the risk of adverse reactions.

The safety and effectiveness have not been established in patients with cirrhosis.

INDICATION

Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). 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.
Limitation of Use: Avoid use in patients with decompensated cirrhosis.

Please see the full Prescribing Information for Rezdiffra.

FDA=Food and Drug Administration; MASH=metabolic dysfunction-associated steatohepatitis, formerly known as NASH or nonalcoholic steatohepatitis.