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.

Intended for US Healthcare Professionals Only
Register now to learn more about Rezdiffra at an upcoming US National Panel Discussion

Rezdiffra is an oral, once-daily tablet that can be taken with or without food1

Tablet is not actual size.

Recommendations for dosing1

  Rezdiffra 80 mg Rezdiffra 100 mg
Dosage One tablet QD One tablet QD
Weight <100 kg (220 lbs) ≥100 kg (220 lbs)

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

Dose modifications with concomitant use of Rezdiffra may be required - click here to learn more.1
Please see full Prescribing Information for details.

CYP2C8 and OATP1B1/OATP1B3 inhibitors

  • Reduce the dose of Rezdiffra if using with moderate CYP2C8 inhibitors (eg, clopidogrel)*
    • 60 mg if <100 kg (220 lbs)
    • 80 mg if ≥100 kg (220 lbs)
  • Concomitant use of Rezdiffra with the following is not recommended:
    • Strong CYP2C8 inhibitors (eg, gemfibrozil)
    • OATP1B1 or OATP1B3 inhibitors (eg, cyclosporin)

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
  • Limit the daily dosage of:
    • rosuvastatin and simvastatin to 20 mg
    • pravastatin and atorvastatin to 40 mg
  • Monitor for statin-related adverse reactions, including liver enzyme elevations, myopathy, and rhabdomyolysis

Madrigal Patient Support helps eligible patients start with their therapy

Get Patients Started
*2% of patients in MAESTRO-NASH were on clopidogrel at baseline.2
CYP2C8=cytochrome P450 2C8; MASH=metabolic dysfunction-associated steatohepatitis, formerly known as NASH or nonalcoholic steatohepatitis; OATP1B1=organic anion transporting polypeptide 1B1; OATP1B3=organic anion transporting polypeptide 1B3; QD=once daily.
References:
  1. Rezdiffra. Prescribing Information. Madrigal Pharmaceuticals, Inc.
  2. Data on file. REF-00630. Madrigal Pharmaceuticals, Inc.; June 2024.

IMPORTANT SAFETY INFORMATION AND INDICATION

EXPAND EXPAND

COLLAPSE COLLAPSE

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

Clinically Significant Interactions Affecting Other Drugs

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 full Prescribing Information for Rezdiffra.

You are now leaving

Madrigal Pharmaceuticals does not review, endorse, or control the content of any non-Madrigal site. Madrigal is not responsible for the accuracy, content, practices, or standards of any non-Madrigal resources accessed through a link on this site.