Rezdiffra (Resmetirom)

Rezdiffra (resmetirom) is a thyroid hormone receptor-beta (THR-beta) agonist designed to work alongside diet and exercise in treating adults with non-cirrhotic nonalcoholic steatohepatitis (NASH), particularly those with moderate to advanced liver fibrosis (stages F2 to F3 fibrosis).

Note: This innovative treatment has been approved under the FDA’s accelerated approval pathway, recognizing its potential to improve both NASH and liver fibrosis. However, continued approval is conditional upon further confirmatory trials that will evaluate and confirm its long-term clinical benefits.

Limitations of Use: Avoid the use of this therapeutic drug in patients with decompensated cirrhosis.

Recommended Dosage: The recommended dosage of Resmetirom is based on actual body weight. For patients weighing:

• <100 kg, the recommended dosage is 80 mg orally once daily.
• ≥100 kg, the recommended dosage is 100 mg orally once daily.

Resmetirom tablets can be taken with or without food. Consult your healthcare provider for personalized dosage recommendations.

• Treatment with Rezdiffra 60 mg/80 mg/100 mg tablets may cause hepatotoxicity, leading to liver injury in some patients. Regular liver function monitoring is recommended, especially in those with a history of liver disease. Patients experiencing symptoms like jaundice, fatigue, or dark urine should consult their healthcare provider immediately. Always follow prescribed dosages to minimize risks.
• Patients taking this therapeutic drug may experience gallbladder-related adverse reactions, including gallstones or cholecystitis. Healthcare providers should assess patients for any history of gallbladder disease and monitor them during treatment. Symptoms like severe abdominal pain, nausea, or vomiting should be reported promptly to ensure timely intervention.
• Resmetirom tablets may interact with certain statins, increasing the risk of muscle-related side effects such as myopathy or rhabdomyolysis. Patients taking both medications should be closely monitored for muscle pain, weakness, or tenderness. Consult your healthcare provider to adjust statin doses or explore alternative treatments when necessary.
• Resmetirom 60 mg/80 mg/100 mg is not recommended during pregnancy due to potential harm to the developing fetus. Pregnant women or those planning to become pregnant should consult their healthcare provider before starting treatment. Alternative therapies should be considered to ensure the safety of both mother and baby during pregnancy.
• Women who are breastfeeding should avoid using Resmetirom as the drug may pass into breast milk and potentially harm the nursing infant. Healthcare providers should evaluate the risks and benefits of treatment in lactating women and consider alternative medications if necessary to safeguard the child’s health.

What is the Generic Name for the trade name drug Rezdiffra®?

Resmetirom is a Generic Name for the trade name drug Rezdiffra®.

What is the Manufacturer’s Name of Rezdiffra®?

Rezdiffra® is manufactured by Madrigal Pharmaceuticals, Inc.

Is Rezdiffra® approved by the FDA?

Yes, Rezdiffra® is approved by the FDA. Date of first approval: March 14, 2024.

What is the dosage and form of Rezdiffra® supplied?

Rezdiffra® is supplied in Tablets: 60 mg, 80 mg, and 100 mg for oral administration.

What are the most common side effects of Rezdiffra®? 

The most common side effects of Rezdiffra® are vomiting, diarrhea, nausea, pruritus, abdominal pain, constipation, and dizziness.

How much does Rezdiffra® 60 mg/80 mg/100 mg cost in India?

Prices may fluctuate over time due to market dynamics and regulatory changes. To obtain accurate and up-to-date information on Rezdiffra 60 mg/80 mg/100 mg tablets cost in India, it is recommended that you Call/WhatsApp +91-9310090915 or send mail to info@indianpharmanetwork.in.

Can Rezdiffra® be available in SAARC countries? 

Apart from Gulf countries, Rezdiffra® can be available in SAARC countries (India, Afghanistan, Maldives, Nepal, Bangladesh, Bhutan, Pakistan, and Sri Lanka). Indian Pharma Network (IPN) can help facilitate the supply of Rezdiffra® tablets in these countries, ensuring access to this therapeutic drug through legal and reliable channels.

Is it safe to buy Rezdiffra® 60 mg/80 mg/100 mg tablets online in India?

Yes, one can buy Rezdiffra 60 mg/80 mg/100 mg online in India at the lowest price from the Indian Pharma Network (IPN) if this medicinal product is not (yet) registered or available in their country. We can help facilitate the supply of Rezdiffra® tablets through legal channels. 

What are the storage conditions of Rezdiffra® 60 mg/80 mg/100 mg tablets?

Store the product at 20°C to 25°C (68°F to 77°F); short-term fluctuations between 15°C to 30°C (59°F to 86°F) are allowed. Ensure proper storage to maintain product effectiveness.