Hay recursos disponibles en español. Explorar los recursos aquí »
For US HCPs Only
Prescribing Information
  Indication
Important Safety Information
Visit Patient Website
Patient Info + Instructions for Use: English  |  Español
Request an Account Manager
TWO FORMULATIONS AVAILABLE

The Only IBAT Inhibitor 
Available as an Oral 
Solution and Tablet1

Simple Dosing

A twice-daily medicine for cholestatic pruritus in patients with PFIC who are ≥12 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,
Twice Per Day

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

If a patient misses a dose of LIVMARLI1:

  • Advise them it should be taken as soon as possible if within 6 hours of the time it is usually taken. They can then resume their original dosing schedule
  • If a dose is missed by more than 6 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; PFIC=progressive familial intrahepatic cholestasis.

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

Twice-Daily Dosing

The recommended dose of LIVMARLI is 570 mcg/kg administered orally (PO) twice daily (BID) as tolerated, taken 30 minutes before a meal1

LIVMARLI 19 mg/mL oral solution for patients with PFIC: volume per dose (mL) by weight1
Patient Weight (kg)285 mcg/kg
(once daily titrated to BID)		428 mcg/kg (BID)570 mcg/kg
(BID as tolerated)
50.10.10.15
6 to 70.10.150.2
80.10.20.25
90.150.20.25
10 to 120.150.250.3
13 to 150.20.30.4
16 to 190.250.40.5
20 to 240.30.50.6
25 to 290.40.60.8
30 to 340.450.70.9
35 to 390.60.81
40 to 490.60.91
50 to 590.811
60 or higher0.911
LIVMARLI tablets for patients with PFIC: dosage by weight1
Patient Weight (kg)285 mcg/kg BID428 mcg/kg BID570 mcg/kg BID
Less than 25Use Oral SolutionUse Oral SolutionUse Oral Solution
25 to 3215 mg
33 to 4310 mg15 mg20 mg
44 or higher15 mg20 mg20 mg

Start dosing at 285 mcg/kg orally once daily in the morning, and increase to 
285 mcg/kg twice daily, 428 mcg/kg twice daily, and then to 570 mcg/kg twice daily, as tolerated1

The maximum daily dose is 38 mg (2 mL) per day for LIVMARLI oral solution and 
40 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 the Patient Brochure

Improvements in Cholestatic Pruritus

Meaningful improvements in cholestatic pruritus were seen as early as 2 weeks and sustained through 2 years.1,4,5

See the Efficacy Data

Always Safety First!

LIVMARLI has a well-characterized safety and tolerability profile for cholestatic pruritus in patients with PFIC.1,4

See the Safety Profile

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) oral solution. Instructions for Use. Mirum Pharmaceuticals, Inc. 3. Data on file. REF-01756. Mirum Pharmaceuticals, Inc. 4. Miethke AG, Moukarzel A, 
Porta G, et al. Maralixibat in progressive familial intrahepatic cholestasis (MARCH-PFIC): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024;9(7):620-631. doi:10.1016/s2468-1253(24)00080-3 5. Miethke A, Moukarzel A, Porta G, et al. Long-term maintenance of response and improved liver health with maralixibat in patients with progressive familial intrahepatic cholestasis (PFIC): 2-year data from the MARCH-ON study. Presented at: North American Study for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting: October 4-7, 2023; San Diego, CA.

INDICATION

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump (BSEP) protein.

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 (DILI).

In the PFIC trial, treatment-emergent hepatic decompensation events and elevations of liver tests or worsening of liver tests occurred. Two patients experienced DILI attributable to LIVMARLI. Two additional patients experienced DILI in the open-label extension portion of the trial. Of these 4 patients, 1 patient required liver transplant and another patient died.

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 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, FSV deficiency, abdominal pain, liver test abnormalities, hematochezia, 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 twice daily 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.

Collapse icon

References: 1. LIVMARLI® (maralixibat). Prescribing Information. Mirum Pharmaceuticals, Inc. 2. LIVMARLI® (maralixibat) oral solution. Instructions for Use. Mirum Pharmaceuticals, Inc. 3. Data on file. REF-01756. Mirum Pharmaceuticals, Inc. 4. Miethke AG, Moukarzel A, 
Porta G, et al. Maralixibat in progressive familial intrahepatic cholestasis (MARCH-PFIC): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024;9(7):620-631. doi:10.1016/s2468-1253(24)00080-3 5. Miethke A, Moukarzel A, Porta G, et al. Long-term maintenance of response and improved liver health with maralixibat in patients with progressive familial intrahepatic cholestasis (PFIC): 2-year data from the MARCH-ON study. Presented at: North American Study for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting: October 4-7, 2023; San Diego, CA.

INDICATION

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump (BSEP) protein.

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 (DILI).

In the PFIC trial, treatment-emergent hepatic decompensation events and elevations of liver tests or worsening of liver tests occurred. Two patients experienced DILI attributable to LIVMARLI. Two additional patients experienced DILI in the open-label extension portion of the trial. Of these 4 patients, 1 patient required liver transplant and another patient died.

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 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, FSV deficiency, abdominal pain, liver test abnormalities, hematochezia, 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 twice daily 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.