BATTLE BILE ACID BUILDUP

About 
LIVMARLI

HEY, EXTRA BILE—
KEEP OUT!

Hey, Extra Bile—Keep Out!

What is LIVMARLI?

green-squiggly-line-horizontal green-squiggly-line-horizontal

LIVMARLI is the first and only medicine that is specifically designed to treat the itch in Alagille syndrome.

Who is LIVMARLI for?

green-squiggly-line-horizontal green-squiggly-line-horizontal

LIVMARLI is FDA approved for cholestatic pruritus (itch) in patients with Alagille syndrome who are 1 year of age and older.

How does LIVMARLI work?

green-squiggly-line-horizontal green-squiggly-line-horizontal

LIVMARLI targets and temporarily blocks something in your body called the ileal bile acid transporter (IBAT). In doing so, LIVMARLI reduces the amount of bile acids in the liver and blood by:

  • Interrupting bile acids from going back into the liver
  • Increasing the amount of bile acids that are excreted (eliminated) from the body in feces

During the first year of treatment, more than 80% of patients experienced a decrease in bile acid buildup with LIVMARLI compared with when they started.

Ileal bile acid transporter (IBAT) inhibitor
LIVMARLI interrupts bile acids
from going back into the liver.
  • First and only treatment for the itch—also known as cholestatic pruritus—in patients with Alagille syndrome who are 1 year of age and older
  • The way LIVMARLI improves itch is not completely known. It may involve inhibition of the IBAT, which interrupts bile acid recycling to the liver and decreases serum bile acids
  • In a clinical study, less bile buildup was associated with less itchiness

SEE HOW LIVMARLI WORKS IN THE BODY

[00:00:00]

FEMALE 1: Let’s take a closer look at bile acid buildup in Alagille syndrome. In the body, a fluid called bile helps break down fat in the food we eat. Bile acids are part of bile. Normally, bile is made in the liver and then moves to the gallbladder for storage. When food enters the small intestine, the bile is then sent in to help with digestion and break down fat. Almost all of the bile

[00:00:30]

and bile acids made by the liver are recycled. This means they return to the liver to be used again. In the intestine, the ileal bile acid transporter, or IBAT, is responsible for bile acid recycling. Bile acids that are not recycled are removed from the body in feces. They are then replaced by new bile acids in the liver. In Alagille syndrome, the flow of bile out of the liver is impaired. This leads

[00:01:00]

to a buildup of bile acids in the liver. Some of the bile acids can also get into the blood. This can cause an increase in bile acids throughout the entire body. In Alagille syndrome, the buildup of bile acids in the liver and blood occurs because of a problem with the tubes, called bile ducts, that allow bile to flow out of the liver. This buildup of bile acids in the liver may cause liver damage and other problems. The most troublesome problem is often a severe itch, also known as cholestatic pruritus. With LIVMARLI,

[00:01:30]

you can aim to ditch the itch, a treatment for patients with itch in Alagille syndrome who are 1 year of age and older, and the first and only FDA-approved medicine for the itch in Alagille syndrome. LIVMARLI inhibits the IBAT and prevents the recycling of bile acids back to the liver. By interrupting the flow

[00:02:00]

of bile acids in this way, LIVMARLI increases the amount of bile acids that are removed from the body in feces and lowers bile acid levels in the body. Although the way by which LIVMARLI improves itch is not completely known, it may involve this decrease in bile acid buildup that occurs with inhibition of the IBAT. In a clinical study, a reduction in bile acid buildup was associated with reductions in itch intensity.

[00:02:30]

FEMALE 2:

INDICATION

LIVMARLI is a prescription medicine used to treat cholestatic pruritus (itch) in patients with Alagille syndrome 1 year of age and older. It is not known if LIVMARLI is safe and effective in children under 1 year of age or in adults 65 years and older.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of LIVMARLI?

LIVMARLI can cause serious side effects, including:

Changes in liver tests. Changes in certain liver tests are common in patients with Alagille syndrome but may worsen during treatment with LIVMARLI. These changes may be a sign of liver injury

[00:03:00]

and can be serious. Your health care provider should do blood tests before starting and during treatment to check your liver function. Tell your health care provider right away if you get any signs or symptoms of liver problems, including:

  • nausea or vomiting
  • skin or the white part of the eye turns yellow
  • dark or brown urine
  • pain on the right side of the stomach (abdomen)
  • loss of appetite

Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea, stomach pain, and vomiting during treatment. Tell your health care provider right away

[00:03:30]

if you have any of these symptoms more often or more severely than normal for you.

A condition called Fat-Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamins A, D, E, and K) stored in body fat. FSV deficiency is common in patients with Alagille syndrome but may worsen during treatment. Your health care provider should do blood tests before starting and during treatment.

Other common side effects reported during treatment were bone fractures and gastrointestinal bleeding.

Tell your health care provider about all medicines that you take. LIVMARLI may affect the way some other medicines work,

[00:04:00]

and some other medicines may affect the way LIVMARLI works. If you take a medicine that lowers cholesterol by binding bile acids, such as cholestyramine, colesevelam, or colestipol, take it at least 4 hours before or 4 hours after you take LIVMARLI.

These are not all of the possible side effects of LIVMARLI. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

FEMALE 1: It’s time for people with Alagille syndrome to take aim against bile acid buildup. It’s time for LIVMARLI.

[00:04:30]

Boy on tire swing Boy on tire swing

Always
Safety
First!

Always Safety First!

Is LIVMARLI safe?

green-squiggly-line-horizontal green-squiggly-line-horizontal

Backed by more than 5 years of safety data,* LIVMARLI has a well-known safety profile in patients with Alagille syndrome.

*From extended observation of patients taking LIVMARLI after completing a placebo-controlled study.

What are the possible side effects?

LIVMARLI may cause side effects. Talk to your or your child’s doctor about what to expect and how to manage any side effects.

The most common side effects with LIVMARLI include:

Changes in liver tests. Changes in certain liver tests are common in patients with Alagille syndrome but may worsen during treatment with LIVMARLI. These changes may be a sign of liver injury and can be serious. Your doctor should do blood tests before starting and during treatment with LIVMARLI to check your liver function. Tell your doctor right away if you have any signs or symptoms of liver problems, including:

  • Nausea or vomiting
  • Your skin or the white part of your eye turns yellow
  • Dark or brown urine
  • Pain on the right side of your stomach (abdomen)
  • Loss of appetite

Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea, stomach pain, and vomiting, and are common but may worsen during treatment with LIVMARLI. Tell your doctor right away if you have any loose stools or have stools more often than normal.

A condition called fat-soluble vitamin (FSV) deficiency caused by low levels of certain vitamins (vitamins A, D, E, and K) stored in body fat. FSV deficiency is common in patients with Alagille syndrome but may worsen during treatment with LIVMARLI. Your doctor should do blood tests before starting and during treatment with LIVMARLI.

Other common side effects reported during treatment with LIVMARLI were bone fractures and gastrointestinal bleeding.

Your doctor may change your dose or temporarily or permanently stop treatment with LIVMARLI if you have certain side effects. These are not all the possible side effects of LIVMARLI. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

LIVMARLI can be taken even if you have other medical conditions.

Stay on Track!
Talk to Your Doctor About LIVMARLI

Talk to Your Doctor About LIVMARLI

Get the conversation started about whether LIVMARLI is right for you or your child.

Mirum Access Plus (MAP) logo

Enroll in Mirum Access Plus (MAP)

Receive support for every step of your LIVMARLI treatment.

Learn How to Enroll
expand btn collapse btn

Indication

LIVMARLI is a prescription medicine used to treat cholestatic pruritus (itch) in patients with Alagille syndrome 1 year of age and older. It is not known if LIVMARLI is safe and effective in children under 1 year of age or in adults 65 years and older.

Important Safety Information

What are the possible side effects 
of LIVMARLI?

LIVMARLI can cause serious side effects, including:

Changes in liver tests. Changes in certain liver tests are common in patients with Alagille syndrome but may worsen during treatment with LIVMARLI. These changes may be a sign of liver injury and can be serious. Your health care provider should do blood tests before starting and during treatment to check your liver function. Tell your health care provider right away if you get any signs or symptoms of liver problems, including:

  • nausea or vomiting
  • skin or the white part of the eye turns yellow
  • dark or brown urine
  • pain on the right side of the stomach (abdomen)
  • loss of appetite

Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea, stomach pain, and vomiting during treatment. Tell your health care provider right away if you have any of these symptoms more often or more severely than normal for you.

A condition called Fat-Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamins A, D, E, and K) stored in body fat. FSV deficiency is common in patients with Alagille syndrome but may worsen during treatment. Your health care provider should do blood tests before starting and during treatment.

Other common side effects reported during treatment were bone fractures and gastrointestinal bleeding.

Tell your health care provider about all medicines that you take. LIVMARLI may affect the way some other medicines work, and some other medicines may affect the way LIVMARLI works. If you take a medicine that lowers cholesterol by binding bile acids, such as cholestyramine, colesevelam, or colestipol, take it at least 4 hours before or 4 hours after you take LIVMARLI.

LIVMARLI is taken by mouth, 1 time each day, 30 minutes before the first meal of the day. Be sure to use the provided oral dosing dispenser to accurately measure the dose of medicine.

These are not all of the possible side effects of LIVMARLI. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Patient Information: English | Español