CONVENIENT, ONCE-DAILY DOSING

A Once-Daily Medicine for Cholestatic Pruritus in Patients With Alagille Syndrome ≥1 Year Old1

Once-Daily Dosing

The recommended dosage of LIVMARLI is 380 mcg/kg administered orally (PO) once daily (QD), taken approximately 30 minutes before the first meal of the day1

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.

Download the
Patient Enrollment Form
Girl riding bike

Instructions for Use

Taken approximately

30

minutes

Hourglass

before the first meal of the day1

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 or opened bottle at room temperature, between

68° F and 77° F

(20° C and 25° C)1

Thermometer

Always store with the

cap on

the bottle1

LIVMARLI bottle

Store the dosing dispenser in a

clean, dry place

when not in use2

Any remaining LIVMARLI 
should be discarded

45 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.

Boy riding bike

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

Stay on Track!

Survey the
Battlefield

Outmatch the scratch with LIVMARLI. Learn how to keep itch at bay for your patients with cholestatic pruritus in Alagille syndrome.

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

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

Learn More About MAP
Collapse icon

Indication

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.

Important Safety Information

Warnings and Precautions

Liver Test Abnormalities: Patients enrolled in clinical trials had abnormal liver tests at baseline. In the main clinical trial, treatment-emergent elevations or worsening of liver tests (ALT, AST or T/DB) relative to baseline were observed. Obtain baseline liver tests and monitor during treatment. 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. Discontinue permanently if a patient progresses to portal hypertension or experiences a hepatic decompensation event.

GI Adverse Reactions: Diarrhea, abdominal pain and vomiting were reported as the most common adverse reactions. If diarrhea, abdominal pain and/or vomiting occur and no other etiologies are found, consider reducing the dose or interrupting LIVMARLI. For diarrhea or vomiting, monitor for dehydration and treat promptly. Consider interrupting LIVMARLI dosing if a patient experiences persistent diarrhea or has diarrhea with accompanying signs and symptoms such as bloody stool, vomiting, dehydration requiring treatment, or fever. Restart LIVMARLI at 190 mcg/kg/day when diarrhea, abdominal pain or vomiting resolve, and increase the dose as tolerated. If they recur upon re-challenge, consider stopping LIVMARLI treatment.

Fat-Soluble Vitamin Deficiency: ALGS patients can have fat-soluble vitamin (FSV) deficiency (vitamins A, D, E, and K) at baseline, and LIVMARLI may affect absorption of FSV. In the main clinical trial, treatment emergent FSV deficiency was reported in 3 (10%) patients during 48 weeks of treatment. Obtain baseline serum levels and monitor during treatment, along with any clinical manifestations. Supplement if deficiency is observed. Consider discontinuing LIVMARLI if FSV deficiency persists or worsens despite adequate FSV supplementation.

Adverse Reactions

The most common adverse reactions (≥5%) are diarrhea, abdominal pain, vomiting, fat-soluble vitamin deficiency, liver test abnormalities, gastrointestinal bleeding 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 the first meal of the day. The provided oral dosing dispenser must be used to accurately measure the dose. Any remaining LIVMARLI should be discarded 45 days after first opening the bottle.

Please see full Prescribing Information for LIVMARLI.