Resmetirom is an innovative drug developed by Madrigal, the United States, and was approved by the U.S. FDA in March 2024, becoming the world's first drug used to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis.
Resmetirom instruction manual
Resmetirom is an oral tablet whose dosage form and specification are designed to fully consider the individual needs of patients. Basic information of drugs and production information are the basis of clinical application.
Basic information about medicines
The active ingredient of Rezdiffra is Resmetirom, and the dosage form is film-coated tablets, which are divided into three specifications: 60mg, 80mg and 100mg. Different specifications are distinguished by the color and label of tablets: 60mg is a white oval tablet, marked "P60"; 80mg is a yellow tablet, marked "P80"; 100mg is beige to pink, marked "P100". The drug must be stored at room temperature and is valid for 24 months.
Production specifications and prices
Currently, the original drug is produced by Madrigal in the United States and has not yet been launched in the country. The generic version of Lucius in Laos has been launched, with 60mg×30tablets selling for about US$1,215, and the prices of 80mg and 100mg specifications increasing with the dose. Patients need to choose a dose based on their weight. If the weight is less than 100kg, it is recommended to have 80mg once a day, and if it is ≥100kg, it is required to have 100mg once a day.
Resmetirom's specification design and pricing strategy reflects its personalized treatment characteristics, but domestic patients need to obtain generic drugs through specific channels and pay attention to drug safety.
Resmetirom indications
This drug is the world's first approved NASH treatment drug. The indications and contraindications of Resmetirom must strictly follow clinical guidelines to clarify the efficacy and safety of the treatment.
Applicable population and indications
Resmetirom is suitable for adult patients with non-cirrhosis of NASH and needs to meet the diagnosis of stage F2 to F3 liver fibrosis. Drugs need to be used in combination with diet control and exercise to delay disease progression in patients with middle and late stage liver fibrosis. Clinical trials have shown that it improves liver inflammation and fibrosis through targeted metabolic pathways.
Contraindications and precautions
Patients with decompensated cirrhosis are prohibited from using this drug, as severe impairment of liver function may aggravate the risk of adverse reactions. In addition, medication should be avoided when combined with strong CYP2C8 inhibitors (such as geffilozi), and moderate inhibitors (such as clopidogrel) should be adjusted to 60 mg or 80 mg once a day. Patients with renal insufficiency do not need to adjust the dose, but there is a lack of research data for those with severe renal impairment.
The scope of indications for Resmetirom is clear. During clinical use, it is necessary to evaluate the patient's liver and renal function and drug interaction to avoid potential risks.
How effective is Resmetirom?
The efficacy and safety of Resmetirom have been verified in clinical trials, but in actual applications, it is necessary to balance the therapeutic effect and adverse reaction management.
Efficacy and clinical application
Studies have shown that Resmetirom can significantly reduce liver fat content and fibrosis scores, and improve pathological indicators in NASH patients. The peak blood drug concentration is reached 4 hours after oral administration, and the bioavailability is high. It targets the improvement of liver metabolic disorders by regulating the β activity of thyroid hormone receptors, becoming an important breakthrough in NASH treatment.
Adverse reactions and management
Common adverse reactions include diarrhea, nausea, pruritus, etc., with an incidence rate of ≥5%. The incidence of adverse reactions in elderly patients is relatively high and monitoring is needed. For pregnant women and breastfeeding women, treatment benefits and potential risks need to be weighed; the safety of children's medication has not yet been clarified and is not recommended for the time being.
Resmetirom provides new treatment options for NASH patients, but it is necessary to standardize medication under the guidance of a doctor and optimize individualized treatment plans in combination with adverse reaction monitoring.
