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Important Safety Information
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Easier Access for Everyone

Making Information Accessible for Patients and Their Families

Mirum is committed to accessibility in everything we do. We value the inclusion of everyone, with consideration of their needs and challenges, and work to ensure this is shown in the experiences we design and websites we create. With this in mind, we continually take steps to improve LIVMARLIhcp.com and ensure it complies with best practices and standards.

Current Accessibility Features

Accessibility and universal usability are important parts of making informed health decisions. Rooted in our mission to transform the lives of patients and their families, the Mirum team utilizes technology, advocacy, and bold action to promote the best experiences for all audiences by employing:

  • Industry standard user-experience (UX) principles
  • Website designs with color contrast and accessibility at the forefront, according to Web Content Accessibility Guidelines (WCAG) 2
  • Inclusive design principles that celebrate the full scope of human diversity
  • Transcripts for our video content, ensuring they are accurate and complete

Our Website and Pages

Our website and landing pages are built with accessibility in mind, according to WCAG 2 best practices. The following issues are considered and remediated:

  • Title attributes for additional information when text is not available
  • Appropriate alternative text detail for images and other non-text elements
  • Graphics and interactive content
  • Form accessibility
  • Table accessibility
  • PDF and web-based brochure accessibility
  • Hierarchy
  • Line length
  • Font choice
  • Color contrast
  • Transcripts
  • Avoiding repetitive flashing in motion design

Investing in Accessibility

At Mirum, we believe it is our responsibility to ensure that content is accessible to everyone. We are dedicated to exploring new solutions, tools, and products to help enhance the overall experience. As we continue to improve our website, we will reflect those changes here within our accessibility statement and keep you informed of our efforts.

Learn More About Accessibility

The Americans with Disabilities Act (ADA)

Website accessibility standards under Title II of the ADA

Federal Communications Commission (FCC)

Twenty-First Century Communications and Video Accessibility Act

Web Accessibility Initiative (WAI)

International standards for the web to improve accessibility for people with disabilities

Web Content Accessibility Guidelines (WCAG) 2 Checklist

Compiled by Web Accessibility in Mind (Web AIM)

World Wide Web Consortium (W3C)

Strategies, standards, and resources to make the web accessible to people with disabilities

We Want to Hear From You

If you encounter any accessibility issues, please let us know. We’re here to help you get the information you need.

You can reach us by visiting the Mirum Pharmaceuticals Contact Page.

Indication

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 3 months 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 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.

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Indication

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 3 months 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 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.