For US HCPs Only
Prescribing Information
  Indication
Important Safety Information
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Patient Information + Instructions for Use

WELCOME TO THE (RESOURCE) LIBRARY

Support for You and Your Practice Is Just a Click Away

Several resources are available to help you prescribe and access LIVMARLI for your patients. Patient-friendly resources are also available to share and discuss with your patients.

LIVMARLI Resources for You

LIVMARLI Brochure

Learn more about LIVMARLI and how it may help appropriate patients.

Mirum Access Plus (MAP) Resources for You

Patient Enrollment Form

Download and fax this form to MAP to prescribe LIVMARLI and/or enroll your patients in MAP support.

Rx to Fill Guide

Refer to this step-by-step guide for more information on prescribing LIVMARLI.

Template Letter of Medical Necessity

Download and use this template letter of medical necessity to support the payer approval process with insurance plans.

Tips for Payer Approval

Keep these tips and questions in mind to help with coverage determination for your patients.

Tips for Appeals

These are some steps that may help if your patients’ insurance plans’ prior authorization or medical exception are denied.

MAP Mobile

Consider this digital option to enroll your patients in MAP support, easily provide their insurance information, and e-sign documents to expedite processing.

LIVMARLI Resources for Patients

Patient Website

Share this website with your patients to explain LIVMARLI treatment in a patient-friendly manner.

Patient Brochure

Provide this resource to your patients considering or receiving LIVMARLI treatment.

Discussion Guide

A short, simple list of questions to help your patients discuss LIVMARLI with you and gain more knowledge about and confidence in getting started.

Mirum Access Plus Resources for Patients

Steps to Getting Medication

This resource helps explain to your patients the initial process of receiving LIVMARLI prescription and treatment.

MAP Brochure

This brochure summarizes the MAP support available to your patients.

Patient Consent Form

Patients can enroll in the support program by texting ENROLL to 1-833-MAP-4YOU (1-833-627-4968). Or, they can download and sign the Patient Consent Form to sign up.

MAP Mobile

Encourage patients to visit the Patient Website to sign up for MAP support through their mobile phones.

Additional Resources for Patients

Teddy Activity Book

An educational children’s book about Alagille syndrome that can help patients understand the disease through storytelling and engaging activities.

Itch✓ App

Itch✓ is an app that makes it simple for patients and caregivers to track symptom patterns over time. The app generates customized reports to share at appointments.

Itch✓ Printable Journal

Patients and caregivers without an iPhone can still bring a detailed symptom journal to their next appointment with the Itch✓ Printable Journal.

Survey the
Battlefield

Outmatch the scratch with LIVMARLI—learn how to help keep itch at bay for your patients with 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

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.

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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.