Rezdiffra
Rezdiffra (resmetirom) is an FDA-approved oral medication used in adults to treat nonalcoholic steatohepatitis (NASH) with liver scarring without cirrhosis. It's the first of its kind to treat this condition, and you only need to take it once a day. You must continue to maintain a healthy diet and exercise while taking this medication in order for it to work well. Common side effects include diarrhea, nausea, and itchiness.
What is Rezdiffra (resmetirom)?
What is Rezdiffra (resmetirom) used for?
Nonalcoholic steatohepatitis (NASH) with liver scarring without cirrhosis, along with diet and exercise
How Rezdiffra (resmetirom) works
Rezdiffra (resmetirom) is a thyroid hormone receptor-beta agonist. It works by activating certain receptors (proteins) in the liver, which helps reduce fat build-up in the liver.
Drug Facts
What are the side effects of Rezdiffra (resmetirom)?
Common Side Effects
- Diarrhea (23-33%)
- Nausea (15-18%)
- Itchy skin (6-10%)
- Vomiting (7-8%)
- Constipation (5-8%)
- Stomach pain (5-7%)
- Dizziness (4%)
Other Side Effects
- Poor appetite
- Gas
- Abnormal stools
- Changes to taste
- Vertigo
- Fast heartbeat
- Low blood sugar
Serious Side Effects
- Liver damage: nausea, vomiting, pain in the upper right area of your stomach, yellowing of the skin or whites of the eyes, fever, rash
- Gallbladder problems: nausea, vomiting, fever, pain in your stomach or back
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Gallbladder problems—severe stomach pain, nausea, vomiting, fever
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Rezdiffra (resmetirom)
Pros
First FDA approved treatment for adults NASH with liver scarring
Only need to take once daily
Can take with or without food
Cons
Not for use in people with cirrhosis of the liver
Interacts with many medications
Commonly causes diarrhea and nausea
Pharmacist tips for Rezdiffra (resmetirom)
You can take Rezdiffra (resmetirom) with or without food. Food doesn't affect how well the medication works.
Make sure you maintain a healthy diet and get regular exercise while taking Rezdiffra (resmetirom) so that it works well for you.
Rezdiffra (resmetirom) can interact with many medications and cause negative side effects. Make sure to tell your liver specialist and pharmacist about all the medications you're taking so they can make sure this medication is safe for you.
Certain medications like clopidogrel (Plavix) cause your body to absorb more Rezdiffra (resmetirom), raising your risk for side effects. As a result, your prescriber might need to lower your Rezdiffra (resmetirom) dose.
Rezdiffra (resmetirom) can interact with some statin medications. Let your prescriber know if you experience any statin side effects like muscle pain or weakness. Your prescriber might need to adjust your statin dose to prevent these side effects.
Rezdiffra (resmetirom) has been linked to liver problems. You'll likely need to do blood work to check that you don't have a rise in liver enzymes. Watch out for symptoms of liver problems, such as stomach pain, nausea, vomiting, fatigue, and yellowing of the eyes or skin.
Frequently asked questions about Rezdiffra (resmetirom)
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What are the risks and warnings for Rezdiffra (resmetirom)?
Rezdiffra (resmetirom) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Liver damage
Although rare, Rezdiffra (resmetirom) can cause abnormal liver labs or liver damage. You might need to have blood work done to check your liver health while you're taking Rezdiffra (resmetirom). Get medical help right away if you develop tiredness, right upper belly pain, yellow skin or eyes, fever, or rash, as these can be signs of liver damage.
Gallbladder damage
People taking Rezdiffra (resmetirom) have had gallbladder problems, like swelling of the gallbladder and gallstones. If you develop pain in your upper stomach, yellow skin or whites of your eyes, or fever, get medical help right away.
Interaction with statin medications
Rezdiffra (resmetirom) can interact with some common statin medications, specifically atorvastatin (Lipitor), pravastatin, simvastatin (Zocor), and rosuvastatin (Crestor). Taking these statin medications with Rezdiffra (resmetirom) can raise your risk of statin-related side effects. Let your prescriber know if you experience symptoms like muscle pain, muscle weakness, tiredness, or fever. Your prescriber might need to adjust your statin dose to prevent these side effects.
Rezdiffra (resmetirom) dosage forms
Typical dosing for Rezdiffra (resmetirom)
Your dose of Rezdiffra (resmetirom) will be based on your body weight.
Weight less than 100 kg (220 lbs): The typical dose is 80 mg by mouth once daily.
Weight 100 kg (220 lbs) or more: The typical dose is 100 mg by mouth once daily.
Your dose might be even lower if you're taking other medications that interact with Rezdiffra (resmetirom).
Rezdiffra (resmetirom) images
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References
Best studies we foundAmerican Liver Foundation. (2024). Nonalcoholic steatohepatitis (NASH).
Harrison, S. A., et al. (2024). A phase 3, randomized, controlled trial of resmetirom in NASH with liver fibrosis. The New England Journal of Medicine.
Madrigal Pharmaceuticals, Inc. (2024). A phase 3 study to evaluate the efficacy and safety of MGL-3196 (Resmetirom) in patients with NASH and fibrosis (MAESTRO-NASH). ClinicalTrials.gov.
Madrigal Pharmaceuticals, Inc. (2024). Rezdiffra- resmetirom tablet, coated; Rezdiffra- resmetirom tablet, coated; Rezdiffra- resmetirom tablet, coated [package insert]. DailyMed.
U.S. Food and Drug Administration. (2024). FDA approves first treatment for patients with liver scarring due to fatty liver disease.
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