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  Indication
Important Safety Information
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CONVENIENT, ONCE-DAILY DOSING

A Once-Daily Medicine for Cholestatic Pruritus in Patients With Alagille Syndrome Who are ≥3 Months of Age1

Once-Daily Dosing

The recommended dosage of LIVMARLI is 380 mcg/kg administered orally (PO) once daily (QD), taken approximately 30 minutes before a meal in the morning1

INDIVIDUAL DAILY DOSE VOLUME AND Rx QUANTITY BY PATIENT WEIGHT1

Patient Weight
(kg)		Days 1 to 7(190 mcg/kg once daily)Beginning Day 8(380 mcg/kg once daily)
Volume QD (mL)Volume QD (mL)
5 to 60.10.2
7 to 90.150.3
10 to 120.20.45
13 to 150.30.6
16 to 190.350.7
20 to 240.450.9
25 to 290.51
30 to 340.61.25
35 to 390.71.5
40 to 490.91.75
50 to 5912.25
60 to 691.252.5
70 or higher1.53

Enroll Your Patients

To prescribe LIVMARLI for appropriate patients, 
download and fill out the Patient Enrollment Form.

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Patient Enrollment Form
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Instructions for Use

Should be taken

30
minutes

clock

before a meal
in the morning1

Oral dosing dispenser provided

0.5 mL

1 mL

3 mL

Oral dosing dispenser

to measure and deliver the prescribed dose accurately1

Please advise patients

Do not use household teaspoon/tablespoon

household teaspoon/ tablespoon

are not adequate measuring devices2

Storage

LIVMARLI bottle

Store unopened LIVMARLI at room
temperature between

68 °F and 77 °F

(20 °C and 25 °C)1

Thermometer

After opening the LIVMARLI bottle,

store below 86 °F (30 °C)

—once opened, the bottle can be refrigerated.1

LIVMARLI bottle

Any remaining LIVMARLI
should be discarded

100 days

after first opening
the bottle1

Clear, colorless to yellow

grape-
flavored

liquid1

Help Your Patients 
Get Started

Provide your patients with the full Patient 
Information and Instructions for Use for LIVMARLI.

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Importance of Adherence

It’s crucial to remind patients that sticking to their therapy is the only way to truly see improvement in their cholestatic pruritus associated with Alagille syndrome. In the ICONIC study, some patients were switched to placebo during the randomized withdrawal period starting at Week 19. Those patients experienced significant increases in cholestatic pruritus. However, once they were switched back to LIVMARLI, their cholestatic pruritus improvements returned.1,3

Of course, human error occurs. If a patient misses a dose of LIVMARLI, advise them it should be taken as soon as possible if within 12 hours of the time it is usually taken. They can then resume their original dosing schedule. If a dose is missed by more than 12 hours, the dose can be omitted and the original dosing schedule resumed.1

Pediatric patients aged 3 months to <12 months had similar safety, tolerability, and pharmacokinetic profiles to those ≥1 year old.1

Root Out
Excess Bile

Learn how LIVMARLI—the first FDA-approved treatment for cholestatic pruritus in Alagille syndrome—battles bile acid buildup.1

See How LIVMARLI Works

Encourage patients to download the Itch✓ app to help them track symptom patterns over time and generate customized reports to share at appointments.

Check Out the Itch✓ App

Mirum Access Plus assists both you and your patients at every turn, helping you navigate the payer approval process—and beyond—with ease.

Learn More About
Mirum Access Plus

References: 1. LIVMARLI® (maralixibat) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc. 2. LIVMARLI® (maralixibat) oral solution. Instructions for Use. Mirum Pharmaceuticals, Inc. 3. Gonzales E, Hardikar W, Stormon M, et al. Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study. Lancet. 2021;398(10311):1581-1592. doi:10.1016/S0140-6736(21)01256-3

INDICATION

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients who are 3 months of age and older with Alagille syndrome.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

LIVMARLI is contraindicated in patients with prior or active hepatic decompensation events (eg, variceal hemorrhage, ascites, or hepatic encephalopathy).

WARNINGS AND PRECAUTIONS

Hepatotoxicity: LIVMARLI treatment is associated with a potential for drug-induced liver injury. In the Alagille syndrome trial, treatment-emergent elevations of liver tests or worsening of liver tests occurred.

Obtain baseline liver tests and monitor during treatment. Liver-related adverse reactions and physical signs of hepatic decompensation should also be monitored. Dose reduction or treatment interruption may be considered if abnormalities occur in the absence of other causes. For persistent or recurrent liver test abnormalities, consider treatment discontinuation. Permanently discontinue LIVMARLI if a patient experiences the following: persistent or recurrent liver test abnormalities, clinical hepatitis upon rechallenge, or a hepatic decompensation event.

Gastrointestinal (GI) Adverse Reactions: Diarrhea and abdominal pain were reported as the most common adverse reactions. Monitor for dehydration and treat promptly. Consider reducing the dosage or interrupting dosing if a patient experiences persistent diarrhea or has diarrhea with bloody stool, vomiting, dehydration requiring treatment, or fever.

Fat-Soluble Vitamin (FSV) Deficiency: Patients can have FSV deficiency (vitamins A, D, E, and K) at baseline, and LIVMARLI may adversely affect absorption of FSVs. If bone fractures or bleeding occur, consider interrupting LIVMARLI and supplement with FSVs. LIVMARLI can be restarted once FSV deficiency is corrected and maintained at corrected levels.

Risk of Propylene Glycol Toxicity (Pediatric Patients Less Than 5 Years of Age): Total daily intake of propylene glycol should be considered for managing the risk of propylene glycol toxicity. Monitor patients for signs of propylene glycol toxicity. Discontinue LIVMARLI if toxicity is suspected.

ADVERSE REACTIONS

The most common adverse reactions are diarrhea, abdominal pain, vomiting, FSV deficiency, liver test abnormalities, and bone fractures.

DRUG INTERACTIONS

Administer bile acid binding resins at least 4 hours before or 4 hours after administration of LIVMARLI.
A decrease in the absorption of OATP2B1 substrates (eg, statins) due to OATP2B1 inhibition by LIVMARLI in the GI tract cannot be ruled out. Consider monitoring the drug effects of OATP2B1 substrates as needed.

DOSING INFORMATION

LIVMARLI should be taken 30 minutes before a meal. The provided oral dosing dispenser must be used to accurately measure the dose. Any remaining LIVMARLI should be discarded 100 days after first opening the bottle.

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References: 1. LIVMARLI® (maralixibat) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc. 2. LIVMARLI® (maralixibat) oral solution. Instructions for Use. Mirum Pharmaceuticals, Inc. 3. Gonzales E, Hardikar W, Stormon M, et al. Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study. Lancet. 2021;398(10311):1581-1592. doi:10.1016/S0140-6736(21)01256-3

INDICATION

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients who are 3 months of age and older with Alagille syndrome.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

LIVMARLI is contraindicated in patients with prior or active hepatic decompensation events (eg, variceal hemorrhage, ascites, or hepatic encephalopathy).

WARNINGS AND PRECAUTIONS

Hepatotoxicity: LIVMARLI treatment is associated with a potential for drug-induced liver injury. In the Alagille syndrome trial, treatment-emergent elevations of liver tests or worsening of liver tests occurred.

Obtain baseline liver tests and monitor during treatment. Liver-related adverse reactions and physical signs of hepatic decompensation should also be monitored. Dose reduction or treatment interruption may be considered if abnormalities occur in the absence of other causes. For persistent or recurrent liver test abnormalities, consider treatment discontinuation. Permanently discontinue LIVMARLI if a patient experiences the following: persistent or recurrent liver test abnormalities, clinical hepatitis upon rechallenge, or a hepatic decompensation event.

Gastrointestinal (GI) Adverse Reactions: Diarrhea and abdominal pain were reported as the most common adverse reactions. Monitor for dehydration and treat promptly. Consider reducing the dosage or interrupting dosing if a patient experiences persistent diarrhea or has diarrhea with bloody stool, vomiting, dehydration requiring treatment, or fever.

Fat-Soluble Vitamin (FSV) Deficiency: Patients can have FSV deficiency (vitamins A, D, E, and K) at baseline, and LIVMARLI may adversely affect absorption of FSVs. If bone fractures or bleeding occur, consider interrupting LIVMARLI and supplement with FSVs. LIVMARLI can be restarted once FSV deficiency is corrected and maintained at corrected levels.

Risk of Propylene Glycol Toxicity (Pediatric Patients Less Than 5 Years of Age): Total daily intake of propylene glycol should be considered for managing the risk of propylene glycol toxicity. Monitor patients for signs of propylene glycol toxicity. Discontinue LIVMARLI if toxicity is suspected.

ADVERSE REACTIONS

The most common adverse reactions are diarrhea, abdominal pain, vomiting, FSV deficiency, liver test abnormalities, and bone fractures.

DRUG INTERACTIONS

Administer bile acid binding resins at least 4 hours before or 4 hours after administration of LIVMARLI.
A decrease in the absorption of OATP2B1 substrates (eg, statins) due to OATP2B1 inhibition by LIVMARLI in the GI tract cannot be ruled out. Consider monitoring the drug effects of OATP2B1 substrates as needed.

DOSING INFORMATION

LIVMARLI should be taken 30 minutes before a meal. The provided oral dosing dispenser must be used to accurately measure the dose. Any remaining LIVMARLI should be discarded 100 days after first opening the bottle.