Uses
What is Rezdiffra used for?
Rezdiffra (resmetirom) is commonly used to treat a specific liver disease called nonalcoholic steatohepatitis (NASH) in people who have scarring in their liver, also called fibrosis. Nonalcoholic steatohepatitis is now referred to as metabolic dysfunction-associated steatohepatitis (MASH).
Rezdiffra may also be used for other conditions as determined by your healthcare provider.
How does Rezdiffra work (mechanism of action)?
Nonalcoholic steatohepatitis occurs when fat builds up in the liver. This buildup of fat causes the liver to become inflamed, causing damage to the liver over time. Rezdiffra works in the liver to reduce fat, preventing further fat buildup and associated damage.
How is Rezdiffra supplied (dosage forms)?
Rezdiffra is available in the following dosage forms that are taken by mouth.
- 60 mg oral tablets
- 80 mg oral tablets
- 100 mg oral tablets
How should I store Rezdiffra?
Store Rezdiffra at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it.
Side Effects
What are the most common side effects of Rezdiffra?
The most common side effects of Rezdiffra are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Diarrhea
- Nausea
- Itching
- Vomiting
- Constipation
- Stomach pain
- Dizziness
There may be other side effects of Rezdiffra that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Rezdiffra?
While less common, the most serious side effects of Rezdiffra are described below, along with what to do if they happen.
Severe Allergic Reactions. Rezdiffra may cause allergic reactions, which can be serious. Stop taking Rezdiffra and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Rezdiffra. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Gallbladder Problems. Taking Rezdiffra can cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Gallstones caused by Rezdiffra can also cause inflammation of the pancreas, which is called pancreatitis. Call your healthcare provider right away if you have any of the following symptoms.
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Fever
- Nausea
- Pain in your upper stomach area
- Stool (poop) that is clay-colored
- Vomiting
Warnings & Precautions
Who should not use Rezdiffra?
Allergies to Ingredients. People who are allergic to any of the following should not take Rezdiffra.
- Rezdiffra
- Resmetirom
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Rezdiffra.
What should I know about Rezdiffra before using it?
Do not take Rezdiffra unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
The dose of Rezdiffra that you are prescribed will be based on your body weight. Take Rezdiffra by mouth once daily, with or without food.
Do not share Rezdiffra with other people, even if they have the same condition as you. It may harm them.
Keep Rezdiffra out of the reach of children.
What should I tell my healthcare provider before using Rezdiffra?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Rezdiffra is right for you.
In particular, make sure that you discuss any of the following.
Liver Problems. Tell your healthcare provider if you have any liver problems besides nonalcoholic steatohepatitis (NASH). This medicine is not for people with cirrhosis of the liver.
Gallbladder Problems. Tell your healthcare provider if you have gallbladder problems, such as gallstones.
Pregnancy. It is not known if or how Rezdiffra could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. It is not known if Rezdiffra passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Rezdiffra while breastfeeding.
Other Medicines and Supplements. Rezdiffra may interact with other medicines and supplements. Before taking Rezdiffra, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
How can I get more information about Rezdiffra?
For more information about Rezdiffra, you can visit the manufacturer’s website at rezdiffra.com or call them at 800-905-0324.
Interactions
Does Rezdiffra interact with foods or drinks?
There are no known interactions between Rezdiffra and foods or drinks.
It is unknown if drinking alcohol will affect Rezdiffra.
Does Rezdiffra interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Rezdiffra.
- Clopidogrel (Plavix), which is a medicine to prevent blood clots
- Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
- Gemfibrozil (Lopid), which is a medicine for high cholesterol
- Atorvastatin (Atorvaliq, Lipitor), which is a medicine used to treat high cholesterol
- Rosuvastatin (Crestor), which is a medicine used to treat high cholesterol
- Pravastatin, which is a medicine used to treat high cholesterol
- Simvastatin (FloLipid, Zocor), which is a medicine used to treat high cholesterol
Many other medicines may alter the blood levels of Rezdiffra, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Rezdiffra. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Rezdiffra?
If you or someone else has used too much Rezdiffra, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Rezdiffra?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.