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Prescribing Information
  Indication
Important Safety Information
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Patient Information + Instructions for Use
NAVIGATING TOGETHER

From Prescription to Refill, Access Support Is Available for Every Step of LIVMARLI Treatment

Getting Patients Started

Mirum Access Plus (MAP) Support Program

If you'd like to prescribe LIVMARLI for your patient, download the Patient Enrollment Form. Once you have filled out the form and/or have your patient consent for MAP services, fax it to MAP at 1-855-282-4884.

Download the Patient Enrollment Form

You can also digitally prescribe LIVMARLI through your electronic medical records by submitting an eRX straight to Eversana Life Science Services, our single-source specialty pharmacy.

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

Download the Patient Enrollment Form

MAP is available to help you, your office, and your patient not only get started with LIVMARLI after you’ve prescribed it, but also to provide support throughout treatment. For new patients, you can begin treatment discussions by providing the Patient Brochure for an overview of LIVMARLI.

Read on to learn about the details of MAP support or see the resources available to you and your patients.

If you have any questions about MAP, contact us at 
1-855-MRM-4YOU (1-855-676-4968) 
Monday through Friday, 8:00 AM through 8:00 PM ET

Ready, Set, Go

Getting Your Patients the Treatment They Need

Support and resources are available through MAP to help you and your office navigate insurance coverage, as well as assist your patients in treatment costs and prescription fulfillment.

Access Support

Insurance Coverage and Access Support

Throughout the payer approval process, MAP works closely with you, your patients, and the insurance plan to help ensure patients get the treatment they need. Consider the following resources to help your patients access LIVMARLI:

Template Letter of Medical Necessity

Tips for Payer Approval

Tips for Appeals

Financial Support for Patients

Financial Support for Patients

MAP provides financial support options:

MAP Savings Program*: Eligible patients with commercial or private insurance will pay as little as $10 out-of-pocket cost for LIVMARLI, subject to the program’s terms, conditions, and limits. This program is provided to patients by the manufacturer of the medication.

Patient Assistance Program (PAP): Provides LIVMARLI at no cost for up to one calendar year for eligible patients without insurance coverage, subject to the program’s terms, conditions, and limits.

Eligible patients may pay
as little as a $10 out of
pocket cost for LIVMARLI.*
Single-Source Specialty Pharmacy

Single-Source Specialty Pharmacy

MAP is a single-source specialty pharmacy that will ship LIVMARLI directly to patients, provide 24/7 access to pharmacists, and proactively manage refills.

*Eligibility restrictions: This program is not available to individuals who use any state or federal government-funded healthcare program to cover a portion of medication costs, such as Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Administration, or any other state or federal government-funded healthcare program.

By Your Side at Every Turn

A Team Dedicated to Alagille Syndrome

Focus on what matters and leave the rest to our experienced and dedicated team at MAP, who will work with your office staff through the access process and assist your patients at every turn.

MAP Coordinators

MAP Coordinators

Available to your office staff and your patients, MAP Coordinators are experts who specialize in the insurance coverage process and available financial support options.

MAP Navigators

Experienced Navigators

Navigators will connect with your patients to provide health education and the emotional support needed to address the difficulties of living with Alagille syndrome.

Mirum Access PLUS

Even More to Help Patients Start and Stay on Therapy

In addition to helping your patients get the treatment they need, MAP offers educational resources and tools for patients who sign up for the program, as described in the MAP Brochure.

Your Patients Can Easily Enroll in MAP

Speak with your patients about enrolling in the MAP support program through one of the following options.

Visit the Patient Website
or
Text “ENROLL” to 1-833-MAP-4YOU (1-833-627-4968)
or
Download the Patient 
Consent Form and fax to MAP at (855) 282-4884

Consider providing the MAP Brochure to help familiarize your patients with all that MAP has to offer them.

If your patients choose to enroll in the free enhanced MAP program, they will have access to an even wider range of support services tailored to them:

Personalized support

Personalized support

Navigators can support all patients by answering questions about LIVMARLI, the disease, or access process. For patients who have provided their consent, navigators can help track treatment goals, develop a support network, and prepare for health care appointments.

Drive adherence

Drive adherence

Navigators can help reinforce adherence in consenting patients by introducing and discussing tools to track pruritus. They will also encourage communication between patients and their physicians about pruritus levels and xanthomas.

Convenient interactions

Convenient interactions

MAP Mobile allows your patients to interact with the program through their mobile devices. Patients can easily provide insurance information, eSign documents to speed up processing, follow the steps to getting their medication with a prescription tracker, and get reminders via text messaging.

Outmatch the
Scratch

Significant improvements in cholestatic pruritus from baseline were achieved as early as Week 3 and maintained through 1 year in patients with Alagille syndrome taking LIVMARLI (P<0.0001).1,2

See the Efficacy Data

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

Always Safety
First!

LIVMARLI has a well-characterized safety and tolerability profile for cholestatic pruritus in patients with Alagille syndrome who are ≥1 year old.3,4

See the Safety Profile

References: 1. 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 2. Gonzales E, Sturm E, Stormon E, et al. Durability of treatment effect with long-term maralixibat in children with Alagille syndrome: 4-year safety and efficacy. Presented at: American Association for the Study of Liver Diseases Annual Meeting: The Liver Meeting; November 8-12, 2019; Boston, MA. 3. LIVMARLI® (maralixibat) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc. 4. Raman RK, Garner W, Vig P, Tucker E. An integrated analysis of long-term clinical safety in maralixibat-treated participants with Alagille syndrome. Poster presented at: European Association for the Study of the Liver (EASL): International Liver Congress; June 23-26, 2021.

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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References: 1. 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 2. Gonzales E, Sturm E, Stormon E, et al. Durability of treatment effect with long-term maralixibat in children with Alagille syndrome: 4-year safety and efficacy. Presented at: American Association for the Study of Liver Diseases Annual Meeting: The Liver Meeting; November 8-12, 2019; Boston, MA. 3. LIVMARLI® (maralixibat) oral solution. Prescribing Information. Mirum Pharmaceuticals, Inc. 4. Raman RK, Garner W, Vig P, Tucker E. An integrated analysis of long-term clinical safety in maralixibat-treated participants with Alagille syndrome. Poster presented at: European Association for the Study of the Liver (EASL): International Liver Congress; June 23-26, 2021.

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.