About NASH Understanding NASH

About NASH Understanding NASH

FATTY LIVER DISEASE & NASH

What is NASH?

Your fatty liver disease could already be NASH with liver scarring. NASH or nonalcoholic steatohepatitis is a serious form of fatty liver disease. It occurs when the fat in the liver becomes toxic to you, damaging liver cells and making the liver inflamed. As the liver reacts to these changes, it gets scarred. This scarring is called fibrosis.

NASH could lead to more
serious conditions like:

Cirrhosis

~1 in 5 people with NASH and advanced scarring will develop cirrhosis in as little as ~2 years.

Need for transplant

NASH is the leading cause of liver transplants in women, and the second leading cause in men.

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Liver cancer

~1 in 8 people with NASH and cirrhosis will develop liver cancer in less than 4 years—but liver cancer can also occur in people who have NASH without cirrhosis.

Shortened life span

NASH may shorten life expectancy.

about 1 in 5 people with fatty liver disease have NASH

people with fatty liver disease have NASH.

90% of adults with NASH don’t know they have it. Now there is a treatment that may be able to help.

Find out if you have NASH. Talk to your liver specialist about getting tested.

STAGES OF NASH & SYMPTOMS

NASH is progressive

Since you can’t see your liver, it’s hard to know the damage that NASH could be causing. Although symptoms of NASH often go unnoticed, some people have reported feeling tired or feeling discomfort in the upper-right side of their abdomen.

Some people’s fatty liver disease may progress faster than others

If NASH is allowed to go undetected and unmanaged for too long it can scar and damage your liver, leaving you at risk for serious health issues. So, get tested if you think you may have NASH.

See how NASH progresses

Testing for NASH

It’s important to get your liver checked for scarring—here’s why

Testing can help determine if your liver has any damage and if you have NASH with scarring. If you have NASH, regular monitoring may be needed to check if your liver has developed scarring. Take care of your liver health by talking to your liver specialist about testing.

If you have type 2 diabetes or are very overweight (obese), you are at a higher risk for having NASH.

You should also talk to your liver specialist if you have any of the following conditions:

  • High blood pressure
  • High triglycerides
  • Abnormal cholesterol levels

It’s recommended that if you have one of these conditions or type 2 diabetes you should get your liver checked for scarring every 1 to 2 years.

Types of tests

Even if you’ve had a blood test for liver enzymes or an ultrasound, you may need other tests to measure fat buildup and scarring (fibrosis) linked to NASH. Ask your liver specialist about these tests:

Blood-based tests can help measure liver enzymes, advanced scarring, and the risk of the disease worsening. Some examples are FIB-4, ELF, and ALT/AST

Imaging and scanning tests can help measure liver stiffness/scarring and fat. Some examples are FibroScan, MRI, and ultrasound technologies

Liver biopsy may be necessary if other tests don’t provide a clear result. In a biopsy, a small sample of liver tissue is taken using a needle and examined in a lab to look for signs of inflammation and scarring

ALT=alanine transaminase; AST=aspartate aminotransferase; ELF=enhanced liver fibrosis; FIB-4=Fibrosis-4; MRI=magnetic resonance imaging.

Working with the right specialist

It may be important to find a doctor who specializes in NASH, especially if your current doctor isn’t familiar with the tests that check for NASH and scarring or can’t answer all of your questions. Below are different types of specialists that can help identify and manage NASH:

Hepatologists diagnose and treat various conditions associated with the liver. They treat acute or chronic liver disease, ranging from fatty liver disease to NASH to cirrhosis to liver cancer. Hepatologists also provide care before and after liver transplants.

Gastroenterologists diagnose and treat conditions affecting your digestive system, including the liver. Some gastroenterologists make liver care their focus.

Nurse Practitioners (NP) and Physician Assistants (PA) may be on your liver specialist’s staff and can help with diagnosing, educating patients, and prescribing treatments.

Picture more for your liver health with Rezdiffra for NASH with liver scarring.

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Important Safety Information and Indication

Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you:

  • have any liver problems other than NASH.
  • have gallbladder problems or have been told you have gallbladder problems, including gallstones.
  • are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works.
  • Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines.
  • Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of Rezdiffra?

Rezdiffra may cause serious side effects, including:

  • liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity, including tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), or stomach pain/tenderness.
  • gallbladder problems. Gallbladder problems such as gallstones, or inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions, including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting.

The most common side effects of Rezdiffra include diarrhea, nausea, itching, stomach pain, vomiting, dizziness, and constipation.

These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal Pharmaceuticals, Inc. at 1-800-905-0324.

What is Rezdiffra?

Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.

This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra.

Please see the full Prescribing Information, including Patient Information, for Rezdiffra.