Resmetirom Dosage

Medically reviewed by Drugs.com. Last updated on Apr 15, 2024.

Usual Adult Dose for Nonalcoholic Steatohepatitis

Dosage based on actual body weight:

• Less than 100 kg: 80 mg orally once a day
• 100 kg or greater: 100 mg orally once a day

Comments:

• Limitations of use: Avoid use of this drug in patients with decompensated cirrhosis.
• Safety and efficacy have not been established in patients with NASH cirrhosis.

Use: In combination with diet and exercise, for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis)

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended
Severe renal dysfunction: Data not available

Liver Dose Adjustments

Mild liver dysfunction: No adjustment recommended
Moderate to severe liver dysfunction (Child-Pugh B or C, or decompensated cirrhosis): Avoid use

Comments:

• Moderate or severe liver dysfunction increases exposure to this drug, which may increase the risk of adverse reactions.

Dose Adjustments

Concomitant Use With Strong CYP450 2C8 Inhibitors (e.g., gemfibrozil): Not recommended

Concomitant Use With Moderate CYP450 2C8 Inhibitors (e.g., clopidogrel):

• Less than 100 kg: 60 mg orally once a day
• 100 kg or greater: 80 mg orally once a day

Concomitant Use With Statins:

• Rosuvastatin and simvastatin: Limit daily dose to 20 mg
• Atorvastatin and pravastatin: Limit daily dose to 40 mg

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For oral use
• This drug may be administered with or without food.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

Monitoring:

• Hepatic: For elevations in liver tests and for the development of liver-related adverse reactions (during treatment)
• Drug interactions: For statin-related adverse reactions (if concomitantly used during treatment)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Report any signs/symptoms of severe liver injury or gallbladder problems to your health care provider.
• Understand that concomitant use of this drug with statins may increase the risk of statin-related adverse reactions.
• Tell your health care provider about all the medicines you take, including prescription medicines and over-the-counter medicines/supplements.
• Patients of childbearing potential: Notify your health care provider of a known/suspected pregnancy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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