Patient Information
Understanding ReMASH™ for Your Liver Health
Tablets for oral use
What is ReMASH?
ReMASH™ is a prescription medicine used along with diet and exercise to treat adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis stages F2-F3), but not with cirrhosis of the liver.
It is not known if ReMASH™ is safe and effective in children under 18 years of age.
Why is ReMASH Important?
MASH can silently progress over time and lead to liver fibrosis (scarring), cirrhosis, or even liver failure. ReMASH is the first and only FDA-approved oral therapy that has shown effectiveness in reducing liver fat, controlling inflammation, and reversing fibrosis in moderate to advanced cases (fibrosis stages F2-F3).
Before you take ReMASH™, tell your healthcare provider about all of your medical conditions, including if you
- Have any liver problems other than MASH
- Have gallbladder problems, including gallstones
- Have high cholesterol or take medicines for blood pressure or diabetes
- Have heart problems or a history of irregular heartbeat
- If you are pregnant or planning to become pregnant
It is not known if ReMASH™ will harm your unborn baby.
If you are breastfeeding or planning to breastfeed
It is not known if ReMASH™ passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ReMASH™.
Tell your healthcare provider about all the medicines you take, including
- Prescription and over-the-counter medicines
- Vitamins and herbal supplements
ReMASH™ may affect the way other medicines work, and other medicines may affect how ReMASH™ works.
Especially tell your healthcare provider if you take:
- medicines that contain gemfibrozil (for triglycerides)
- cyclosporine (for immune suppression)
- clopidogrel (blood thinner)
- statin medicines (to lower cholesterol)
Keep a list of all your medicines and share it with your doctor or pharmacist when you get a new prescription.
How should I take ReMASH™?
- Take ReMASH™ exactly as your healthcare provider tells you.
- Your dose is based on your body weight and liver condition.
- Take ReMASH™ by mouth, once a day, with or without food.
- Try to take it at the same time every day.
What are the possible side effects of ReMASH™?
ReMASH™ may cause serious side effects, including:
Liver injury (hepatotoxicity)
Stop taking ReMASH™ and call your healthcare provider right away if you develop:
Tiredness
Nausea or Vomiting
Fever
Rash
Pain or tenderness in the upper right side of your stomach
Yellowing of your skin or the white part of your eyes (jaundice)
Gallbladder problems
Gallstones, inflammation of the gallbladder, or pancreas issues can occur in people with MASH and may be worsened by ReMASH™.
Call your doctor right away if you have:
Stomach pain that doesn't go away
Pain that spreads to your back
Vomiting
Fever or Chills
The most common side effects of ReMASH™ include
Nausea
Diarrhoea
Dizziness
Constipation
Stomach pain
Itching
Vomiting
These are not all possible side effects. Talk to your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the possible side effects of ReMASH™?
ReMASH™ may cause serious side effects, including:
Liver injury (hepatotoxicity)
Tiredness
Nausea or Vomiting
Fever
Rash
Pain or tenderness in the upper right side of your stomach
Yellowing of your skin or the white part of your eyes (jaundice)
Gallbladder problems
Gallstones, inflammation of the gallbladder, or pancreas issues can occur in people with MASH and may be worsened by ReMASH™.
Call your doctor right away if you have:
Stomach pain that doesn't go away
Pain that spreads to your back
Vomiting
Fever or Chills
Rash
The most common side effects of ReMASH™ include
Nausea
Diarrhoea
Dizziness
Constipation
Stomach pain
Itching
Vomiting
These are not all possible side effects. Talk to your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
How should I store ReMASH™?
- Store ReMASH™ at room temperature between 68°F to 77°F (20°C to 25°C)
- Keep the bottle tightly closed
- Keep out of reach of children
General information about safe and effective use of ReMASH™
- Do not share ReMASH™ with others, even if they have the same symptoms
- Do not use it for a condition not prescribed
- You can ask your healthcare provider or pharmacist for more information
What are the ingredients in ReMASH™?
- Active ingredient: resmetirom
- Inactive ingredients include mannitol, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and film coating agents such as polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and colorants.
If you've been diagnosed with MASH, ReMASH™ may be the first step toward taking back control of your liver health.
