What is it prescribed for?
REZDIFFRA, approved on March 14, 2024, is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.
What is the name of the drug and what does it do?
Rezdiffra (pronounced rez-DIF-rah), (generic name: resmetirom), is a medication indicated for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (stages F2 to F3 fibrosis). It is used in conjunction with diet and exercise to improve liver health and reduce fibrosis.
How does it work?
Rezdiffra is a thyroid hormone receptor-beta (THR-beta) agonist. It works by selectively activating the thyroid hormone receptor-beta in the liver, which helps reduce liver fat content and improve liver function. This mechanism helps in reducing the inflammation and fibrosis associated with NASH, thereby improving liver health.
What did the research discover?
Clinical trials demonstrated that Rezdiffra effectively improves liver health in patients with NASH. In a study involving 888 patients with stages F2 and F3 fibrosis, Rezdiffra significantly increased the percentage of patients who achieved resolution of steatohepatitis without worsening of fibrosis. Additionally, the trials showed an improvement in liver fibrosis in a notable percentage of patients, demonstrating Rezdiffra’s potential in managing NASH and improving liver function.
What are some of the side effects?
- Diarrhea
- Nausea
- Pruritus (itching)
- Vomiting
- Constipation
- Abdominal pain
- Dizziness
What are the dosage recommendations and how is it prescribed?
The recommended dosage of Rezdiffra is based on actual body weight:
- For patients weighing less than 100 kg: 80 mg orally once daily.
- For patients weighing 100 kg or more: 100 mg orally once daily.
Rezdiffra can be administered with or without food. Dosage modifications are required when used concomitantly with moderate CYP2C8 inhibitors, such as clopidogrel. In such cases, the dosage is reduced to 60 mg once daily for patients weighing less than 100 kg and 80 mg once daily for those weighing 100 kg or more.
Source:
Madrigal Pharmaceuticals, Inc. Rezdiffra (resmetirom) tablets, for oral use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217785s000lbl.pdf
