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RISE ABOVE 
CHOLESTATIC PRURITUS (ITCH)

About LIVMARLI

ROOT OUT
EXCESS BILE

What is LIVMARLI?

LIVMARLI Bottle
LIVMARLI can work within weeks

A medicine that is specifically designed to treat cholestatic pruritus in progressive familial intrahepatic cholestasis (PFIC)

LIVMARLI can work within weeks

FDA approved for cholestatic pruritus in patients with PFIC who are 12 months of age and older

How does LIVMARLI work?

LIVMARLI targets and temporarily blocks something in the body called the ileal bile acid transporter, or IBAT. In doing so, LIVMARLI lowers bile acids in the body (as measured by levels in the blood) by:

  • Interrupting bile acids from going back into the liver
  • Increasing the amount of bile acids that are removed from the body in feces
Mechanism of Action With Ileal Bile Acid Transporter (IBAT) Inhibition

Half of patients taking LIVMARLI in the All-PFIC group had their serum bile acid (sBA) levels reduced by more than 75% or had their sBA decrease to below 102 µmol/L.

The way LIVMARLI improves cholestatic pruritus is not completely known. It may involve inhibition of the IBAT, which interrupts bile acid recycling to the liver and decreases serum bile acids.

Always
Safety
First!

Always Safety First!

Is LIVMARLI safe?

LIVMARLI has well-established safety and tolerability in patients with cholestatic pruritus in PFIC.

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.

LIVMARLI can work within weeks
The most common side effects with LIVMARLI include:
  • Diarrhea
  • Abdominal pain
  • Liver test abnormalities
  • Other common side effects include rectal bleeding and bone fractures

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.

Lower Costs Within Reach

Mirum Access Plus works closely with your doctor and insurance plan to help facilitate coverage for LIVMARLI.

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Convenient Dosing

Once you and your doctor have decided that LIVMARLI is the right treatment, here’s how and when you can take your liquid medicine.

Explore LIVMARLI Dosing

INDICATION

LIVMARLI is a prescription medicine used to treat cholestatic pruritus (itch) in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

LIVMARLI is not for use in PFIC type 2 patients who have a severe defect in the bile salt export pump (BSEP) protein.

It is not known if LIVMARLI is safe and effective in children with PFIC who are under 12 months of age. It is not known if LIVMARLI is safe and effective in adults who are 65 years of age and older.

IMPORTANT SAFETY INFORMATION

What are the possible side effects 
of LIVMARLI?

LIVMARLI can cause serious side effects, including:

  • Liver injury. Changes in certain liver tests are common in patients with PFIC but may worsen during treatment. These changes may be a sign of liver injury and can be serious or may lead to transplant or death. Your health care provider should do blood tests and physical exams before starting and during treatment with LIVMARLI 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
    • your skin or the white part of your eye turns yellow
    • dark or brown urine
    • pain on the right side of your stomach (abdomen)
    • fullness, bloating, or fluid in your stomach area (ascites)
    • loss of appetite
    • bleeding or bruising more easily than normal, including vomiting blood
  • Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain during treatment. Diarrhea can also cause the loss of too much body fluid (severe dehydration). Your health care provider may advise you to monitor for new or worsening stomach problems, including stomach pain, diarrhea, blood in your stool, or vomiting

    Tell your health care provider right away if you have any new or worsening signs or symptoms of stomach and intestinal problems, including:
    • diarrhea
    • more frequent bowel movements than usual
    • stools that are black, tarry, or sticky, or have blood or mucous
    • severe stomach-area pain or tenderness
    • vomiting
    • urinating less often than usual
    • dizziness
    • headache
  • A condition called Fat-Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat. FSV deficiency is common in patients with PFIC but may worsen during treatment. Your health care provider should do blood tests before starting and during treatment, and may monitor for bone fractures and bleeding, which are common side effects

Tell your health care provider about all medicines that you take, as LIVMARLI may interact with other medicines. 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.

Your health care provider may change your dose, or temporarily or permanently stop treatment with LIVMARLI if you have certain side effects.

LIVMARLI is taken by mouth, 2 times each day, 30 minutes before a meal. 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. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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INDICATION

LIVMARLI is a prescription medicine used to treat cholestatic pruritus (itch) in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

LIVMARLI is not for use in PFIC type 2 patients who have a severe defect in the bile salt export pump (BSEP) protein.

It is not known if LIVMARLI is safe and effective in children with PFIC who are under 12 months of age. It is not known if LIVMARLI is safe and effective in adults who are 65 years of age and older.

IMPORTANT SAFETY INFORMATION

What are the possible side effects 
of LIVMARLI?

LIVMARLI can cause serious side effects, including:

  • Liver injury. Changes in certain liver tests are common in patients with PFIC but may worsen during treatment. These changes may be a sign of liver injury and can be serious or may lead to transplant or death. Your health care provider should do blood tests and physical exams before starting and during treatment with LIVMARLI 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
    • your skin or the white part of your eye turns yellow
    • dark or brown urine
    • pain on the right side of your stomach (abdomen)
    • fullness, bloating, or fluid in your stomach area (ascites)
    • loss of appetite
    • bleeding or bruising more easily than normal, including vomiting blood
  • Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain during treatment. Diarrhea can also cause the loss of too much body fluid (severe dehydration). Your health care provider may advise you to monitor for new or worsening stomach problems, including stomach pain, diarrhea, blood in your stool, or vomiting

    Tell your health care provider right away if you have any new or worsening signs or symptoms of stomach and intestinal problems, including:
    • diarrhea
    • more frequent bowel movements than usual
    • stools that are black, tarry, or sticky, or have blood or mucous
    • severe stomach-area pain or tenderness
    • vomiting
    • urinating less often than usual
    • dizziness
    • headache
  • A condition called Fat-Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat. FSV deficiency is common in patients with PFIC but may worsen during treatment. Your health care provider should do blood tests before starting and during treatment, and may monitor for bone fractures and bleeding, which are common side effects

Tell your health care provider about all medicines that you take, as LIVMARLI may interact with other medicines. 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.

Your health care provider may change your dose, or temporarily or permanently stop treatment with LIVMARLI if you have certain side effects.

LIVMARLI is taken by mouth, 2 times each day, 30 minutes before a meal. 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. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.