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)
Patient Weight (kg)	Volume QD (mL)	Volume QD (mL)
5 to 6	0.1	0.2
7 to 9	0.15	0.3
10 to 12	0.2	0.45
13 to 15	0.3	0.6
16 to 19	0.35	0.7
20 to 24	0.45	0.9
25 to 29	0.5	1
30 to 34	0.6	1.25
35 to 39	0.7	1.5
40 to 49	0.9	1.75
50 to 59	1	2.25
60 to 69	1.25	2.5
70 or higher	1.5	3

Enroll Your Patients

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

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Patient Enrollment Form

Instructions for Use

Should be taken

30
minutes

before a meal
in the morning¹

Oral dosing dispenser provided

0.5 mL

1 mL

3 mL

to measure and deliver the prescribed dose accurately¹

Please advise patients

household teaspoon/ tablespoon

are not adequate measuring devices²

Storage

Store unopened LIVMARLI at room
temperature between

68 °F and 77 °F

(20 °C and 25 °C)¹

After opening the LIVMARLI bottle,

store below 86 °F (30 °C)

—once opened, the bottle can be refrigerated.¹

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

Turning Over a New Leaf in Alagille Syndrome

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

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 a meal in the morning. 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.

Please see full Prescribing Information for LIVMARLI.