HEY, EXTRA BILE—
What is LIVMARLI?
LIVMARLI is the first and only medicine that is specifically designed to treat the itch in Alagille syndrome.
Who is LIVMARLI for?
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?
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.
- 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
Is LIVMARLI safe?
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.