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These Terms of Use are governed by the internal substantive laws of the State of California, without resort to its conflict of laws principles. If any provision of these Terms of Use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of these Terms of Use. You expressly agree that exclusive jurisdiction for any dispute with Mirum, or in any way relating to your use of this site, resides in the courts of the State of California. Mirum may terminate this agreement, terminate your access to all or part of the site, or suspend any user’s access to all or part of the site, at any time, without notice to you, if it believes, in its sole judgment, that you have breached or may breach any term or condition of this agreement, or for its convenience. You may terminate this agreement at any time by destroying all materials received from the site and ceasing to use the site.

Except as expressly provided in a particular “legal notice” on this site, these Terms of Use constitute the entire agreement between you and Mirum with respect to the use of this site, and content. Your use of this site is also subject to the Privacy Statement.

Without prejudice to your rights under applicable law, Mirum reserves the right to amend these Online Terms of Use to reflect technological advancements, legal and regulatory changes and good business practices. If Mirum changes these Online Terms of Use, an updated version of these Online Terms of Use will reflect those changes. An updated effective date at the top of these Online Terms of Use will constitute notice of such changes. By accessing or using our website, you agree that you have read, understand, and agree to be bound to the current version of these Online Terms of Use, which you may view when accessing the Mirum website. If you disagree with these Online Terms of Use, or are dissatisfied with our website, your sole and exclusive remedy is to discontinue using the Mirum website.

Last Updated: February 5, 2021

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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.