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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 30 minutes before a meal in the morning.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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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
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Descargar un Diario Imprimible
Itch✓ app on iPhone

Watch Itch✓ in Action

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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 on 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.
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Descargar un Diario Imprimible

Apple®, iPhone®, App Store®, and the Apple logo® are trademarks of Apple Inc.

Android is a trademark of Google LLC.

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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 30 minutes before a meal in the morning.1

Look Into LIVMARLI Dosing

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

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) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc. 2. Gonzales E, Hardikar W, Stormon M, et al. Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study. Lancet. 2021;398(10311):1581-1592. doi:10.1016/S0140-6736(21)01256-3

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 dosing 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. If bone fractures or bleeding occur, 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): 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 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. 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.

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References: 1. LIVMARLI® (maralixibat) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc. 2. Gonzales E, Hardikar W, Stormon M, et al. Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study. Lancet. 2021;398(10311):1581-1592. doi:10.1016/S0140-6736(21)01256-3

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 dosing 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. If bone fractures or bleeding occur, 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): 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 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. 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.