THANKS FOR YOUR SUPPORT!

With Your Support, Patients Can Better Manage Their Condition and Treatment

Tips for Setting Patient Expectations

1

Remind patients that sticking to their therapy is the only way to truly see improvement in their cholestatic pruritus. If a dose of LIVMARLI is missed, advise patients 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 the next day.1

2

Counsel patients that cholestatic pruritus may improve at different times or rates when taking LIVMARLI. Results may be experienced as early as 3 weeks but could also take up to 3 months.2

3

Advise patients that LIVMARLI should be taken in the morning, 30 minutes before the first meal of the day.1

4

Alert patients that you will instruct them to increase their dose of LIVMARLI after 1 week.1

5

Inform patients that the most common side effects were gastrointestinal (diarrhea, abdominal pain, and vomiting).1,2

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Itch✓ logo

Check it. Chart it. Discuss it.™

Self-monitoring Can Help Make Follow-up Visits More Productive

Encourage patients to keep track of changes in symptoms in between their appointments with the Itch✓ app. This app enables patients with Alagille syndrome to chart progress and then discuss results with you. Overall, Itch✓ is a simple yet detailed symptom journal designed to help both you and your patients and their caregivers make sense of itch severity.

The app is based on the validated ItchRO—or Itch Reported Outcomes—scale, which was used in the pivotal ICONIC study. This observer- and patient-reported outcome tool was developed using a cognitive debriefing approach in families that had children with Alagille syndrome. It utilizes a 5-point severity scale ranging from 0=“not itchy at all” to 4=“extremely itchy”. During the clinical trial, the ItchRO assessment was completed using an electronic diary (eDiary).2

Itch✓ app on iPhone

How Itch✓ Works

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Your patients and their caregivers will use Itch✓ twice a day—once in the morning and once in the evening—to create a journal of symptoms and observations.

Itch✓ Features

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Detailed charts (itch severity and growth patterns vs standard percentiles)

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Notes and photos for more detailed entries

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Anytime entries (patients and/or caregivers can log additional observations throughout the day if they choose)

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Customizable weekly reports that patients and their caregivers can easily share with you

3 Reasons Your Patients and Their Caregivers Will Love Itch✓

  1. Learn patterns to make sense of symptoms: Your patients and their caregivers will see symptom patterns over time with charts based off of their observations.
  2. Stay organized with all entries in one place: Your patients’ and their caregivers’ observations will be categorized based on date and entry type, making it easy for them to view and edit entries.
  3. Share reports to keep YOU in the know: A weekly report generated by Itch✓ will help your patients and their caregivers be better prepared for their upcoming visits with you. Reports include average itch severity, growth percentile data, photos, notes, and more.

Apple logo® and App Store® are registered trademarks of Apple Inc.

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Mirum Is Your Partner in Patient-centric Care

Mirum has a driven and focused team whose mission is to create transformative, life-changing medicine for patients with rare cholestatic liver disease. We have a strong understanding of the significant impact cholestatic liver disease has on quality of life for patients and caregivers. With 140+ industry veterans, scientists, and thought-leaders, Mirum is backed by significant expertise in liver disease and pharmaceutical development. We aim to always provide dedicated leadership and safe, effective treatments that you, your patients, and their caregivers can rely on.

Discover Mirum

Convenient
Once-daily
Dosing

LIVMARLI is administered orally once daily approximately 30 minutes before the first meal of the day.1

Look Into LIVMARLI Dosing

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

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
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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.