Resmetirom
Generic name: resmetirom [ RES-me-TIR-om ]
Brand name: Rezdiffra
Dosage form: oral tablet (100 mg; 60 mg; 80 mg)
Drug class: Miscellaneous metabolic agents
What is resmetirom?
Resmetirom is used in adults together with diet and exercise to treat a certain type of fatty liver disease called nonalcoholic steatohepatitis (NASH) with moderate to severe liver fibrosis.
Resmetirom is not used to treat nonalcoholic steatohepatitis (NASH) with liver cirrhosis.
Resmetirom may also be used for purposes not listed in this medication guide.
Resmetirom side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Resmetirom may cause serious side effects. Call your doctor at once if you have:
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fever, nausea, vomiting;
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liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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gallbladder problems--chalky-colored stools, stomach pain after eating, heartburn, bloating, and severe upper stomach pain that may spread to your back.
Common side effects of resmetirom may include:
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diarrhea;
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stomach pain, constipation;
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nausea, vomiting;
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dizziness; or
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itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Warnings
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
Related/similar drugs
Rezdiffra
Before taking this medicine
Tell your doctor if you have or have ever had:
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gallbladder problems, including gallstones; or
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liver problems (other than NASH).
It is not known if resmetirom will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using resmetirom.
How should I take resmetirom?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Resmetirom is usually taken once per day. Follow your doctor's instructions.
You may take resmetirom with or without food, but take it the same way each time.
Doses are based on weight. Your dose may change if you gain or lose weight.
You will need frequent medical tests and blood tests to check your liver function. Your next dose may be delayed based on the results.
Store at room temperature away from moisture and heat.
Resmetirom dosing information
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)
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking resmetirom?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect resmetirom?
Resmetirom can harm your liver, especially if you also use certain medicines for infections, birth control, high cholesterol, seizures, pain, or arthritis (including Advil).
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.
Tell your doctor about all your other medicines, especially:
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medicine used to prevent blood clots such as clopidogrel;
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a cholesterol lowering medicine such as simvastatin, rosuvastatin, pravastatin and atorvastatin;
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gemfibrozil; or
Other drugs may affect resmetirom, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
More about resmetirom
Patient resources
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Professional resources
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Related treatment guides
Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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