General Information
Manufacturer: Madrigal
Medical Name: Resmetirom
Purpose: Rezdiffra (resmetirom) is the first and only FDA-approved medication used, along with diet and exercise, to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis). It is not for use in patients with cirrhosis of the liver.
Side Effects
| Side-Effect | Rezdiffra 80 mg | Rezdiffra 100 mg | Further description |
|---|---|---|---|
| Diarrhea | 23% | 33% | Diarrhea usually started early and was mild to moderate in severity, with a median duration of about 20 days. |
| Nausea | 18% | 15% | Nausea also began early and was mild to moderate, with a median duration of about 26-28 days. |
| Pruritus (itching) | 6% | 10% | |
| Vomiting | 7% | 8% | |
| Constipation | 5% | 8% | |
| Abdominal pain | 5% | 7% | |
| Dizziness | 4% | 4% |
Serious but Less Common Side Effects
| Side Effect | Description |
|---|---|
| Liver Injury (Hepatotoxicity) | Elevations in liver enzymes (ALT and AST) were observed, typically returning to baseline after about 8 weeks. One case of drug-induced autoimmune-like hepatitis was reported in a clinical trial. |
| Gallbladder-Related Adverse Reactions | A higher incidence of gallstones (cholelithiasis), inflammation of the gallbladder (acute cholecystitis), and gallstone-related inflammation of the pancreas (obstructive pancreatitis) was observed in patients taking Rezdiffra compared to placebo. The exposure-adjusted incidence rates for these events were less than 1 per 100 PY for all treatment arms. |
| You should contact your healthcare provider immediately if you experience symptoms of liver injury (e.g., yellowing skin/eyes, fever, severe stomach pain, persistent nausea/vomiting) or gallbladder problems (e.g., severe abdominal pain that radiates to the back, fever, chills). | |
Contraindications - Do Not Use Medication
| Precondition | Description |
|---|---|
| Decompensated Cirrhosis | Avoid use in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C) or decompensated cirrhosis. Use in patients with compensated cirrhosis (Child-Pugh Class A) should be done with caution and close monitoring for signs of hepatic decompensation. |
| Hypersensitivity/Allergy | The drug should not be used in patients with a history of a hypersensitivity reaction to resmetirom or any of its ingredients. |
| Active Gallbladder Disease | Use with caution in patients with current or prior gallbladder problems, such as gallstones or cholecystitis, as Rezdiffra may increase the risk of gallbladder-related adverse reactions. |