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Important Safety Information
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TWO FORMULATIONS AVAILABLE

The Only IBAT Inhibitor 
Available as an Oral 
Solution and Tablet1

Simple Dosing

A once-daily medicine for cholestatic pruritus in patients with Alagille syndrome who are ≥3 months of age1

LIVMARLI oral solution

A dosing dispenser is provided to measure and deliver the prescribed dose accurately.1*

Clear, colorless to yellow grape-flavored liquid.1

LIVMARLI bottle and syringe not actual size.

LIVMARLI tablets

Tablets can be used in patients ≥25 kg who are able 
to swallow them. They are available in 4 strengths1:

Tablets and dime not actual size.

Dime shown for scale.

One Dose,
Once Per Day

Both LIVMARLI oral solution and tablets should be taken once daily 30 minutes before a meal in the morning at the dosage prescribed1

If a patient misses a dose of LIVMARLI1:

  • 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

*Please advise patients that household teaspoons and tablespoons are not adequate measuring devices.2

IBAT=ileal bile acid transporter.

Prescribing LIVMARLI

To prescribe LIVMARLI for appropriate patients, download and fill out the Patient Enrollment form, and refer to the charts below for patient dosing details.

Download the
Patient Enrollment Form
background-section

Once-Daily Dosing

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

Daily dose volume and Rx quantity by patient weight for LIVMARLI 9.5 mg/mL oral solution in patients with Alagille syndrome1

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

Dose by patient weight for LIVMARLI tablets for patients with Alagille syndrome1†

Patient Weight
(kg)		Days 1 to 7(190 mcg/kg once daily)Beginning Day 8(380 mcg/kg once daily)
Less than 25Use Oral SolutionUse Oral Solution
25 to 3210 mg
33 to 4315 mg
44 to 6510 mg20 mg
66 or higher15 mg30 mg

†Select the appropriate product based on the patient's weight and ability to swallow tablets.

Start dosing at 190 mcg/kg orally once daily; after 1 week, increase to 
380 mcg/kg once daily, as tolerated1

The maximum daily dose is 28.5 mg (3 mL) per day for LIVMARLI oral solution and 
30 mg per day for LIVMARLI tablets1

Tips for patients taking oral solution

  • Be mindful of placement. Use the measuring device that comes with LIVMARLI to squirt the medicine into the inside of the cheek
  • Add a flavorful twist. Suggest patients suck on fruit, such as an orange or lemon, before or after taking LIVMARLI
  • Cool it. Once opened, consider storing LIVMARLI in the refrigerator3

Reminder: Advise patients to discard any remaining LIVMARLI oral solution 100 days after first opening the bottle.

Help Your Patients 
Get Started

Provide your patients with the Patient Brochure to help them get to know LIVMARLI.

Download Patient Brochure

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). Prescribing Information. Mirum Pharmaceuticals, Inc. 2. LIVMARLI® (maralixibat). Instructions for Use. Mirum Pharmaceuticals, Inc. 3. Data on file. REF-01756. Mirum Pharmaceuticals, Inc.

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 LIVMARLI treatment 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. Treatment-emergent bone fracture events have been observed more frequently with patients treated with LIVMARLI compared with patients treated with placebo. If bone fractures or bleeding occurs, 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): LIVMARLI oral solution contains propylene glycol. 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 LIVMARLI at least 4 hours before or 4 hours after administration of bile acid binding resins.

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. Refer to the dosing by weight guidelines in the full Prescribing Information for complete details on dosing for the oral solution and tablet formulations. The provided oral solution dosing dispenser must be used to accurately measure the dose. Any remaining LIVMARLI oral solution should be discarded 100 days after first opening the bottle. LIVMARLI tablets can be used in patients weighing ≥25 kg who can swallow tablets.

Please see full Prescribing Information for LIVMARLI.

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References: 1. LIVMARLI® (maralixibat). Prescribing Information. Mirum Pharmaceuticals, Inc. 2. LIVMARLI® (maralixibat). Instructions for Use. Mirum Pharmaceuticals, Inc. 3. Data on file. REF-01756. Mirum Pharmaceuticals, Inc.

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 LIVMARLI treatment 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. Treatment-emergent bone fracture events have been observed more frequently with patients treated with LIVMARLI compared with patients treated with placebo. If bone fractures or bleeding occurs, 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): LIVMARLI oral solution contains propylene glycol. 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 LIVMARLI at least 4 hours before or 4 hours after administration of bile acid binding resins.

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. Refer to the dosing by weight guidelines in the full Prescribing Information for complete details on dosing for the oral solution and tablet formulations. The provided oral solution dosing dispenser must be used to accurately measure the dose. Any remaining LIVMARLI oral solution should be discarded 100 days after first opening the bottle. LIVMARLI tablets can be used in patients weighing ≥25 kg who can swallow tablets.

Please see full Prescribing Information for LIVMARLI.