LIVMARLI (maralixibat) oral solution
LIVMARLI (maralixibat) is an ileal bile acid transporter inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) three months of age and older. LIVMARLI is also approved for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) five years of age and older.
LIVMARLI is not for use in patients with PFIC type 2 who have a severe defect in the bile salt export pump (BSEP) protein.
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LIVMARLI in ALGS
LIVMARLI in PFIC
LIVMARLI in Alagille Syndrome
LIVMARLI (maralixibat) is an ileal bile acid transporter inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) three months of age and older.
LIVMARLI can cause serious side effects, including:
Liver injury. Changes in certain liver tests are common in patients but may worsen during treatment with LIVMARLI. These changes may be a sign of liver injury and can be serious. Your health care provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your health care provider right away if you get any signs or symptoms of liver problems, including:
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Healthcare Providers:
Please see full prescribing information for
healthcare providers
Patients and Families: PLEASE SEE PATIENT PRODUCT INFORMATION AND
INSTRUCTIONS FOR USE
healthcare providers
Patients and Families: PLEASE SEE PATIENT PRODUCT INFORMATION AND
INSTRUCTIONS FOR USE
Important Safety Information
What are the possible side effects of LIVMARLI?LIVMARLI can cause serious side effects, including:
Liver injury. Changes in certain liver tests are common in patients but may worsen during treatment with LIVMARLI. These changes may be a sign of liver injury and can be serious. Your health care provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your health care provider right away if you get any signs or symptoms of liver problems, including:
- nausea or vomiting
- your skin or the white part of the eye turns yellow
- dark or brown urine
- pain on the right side of the stomach (abdomen)
- fullness, bloating, or fluid in your stomach area (ascites)
- loss of appetite
- bleeding or bruising more easily than normal, including vomiting blood
- diarrhea
- more frequent bowel movements than usual
- stools that are black, tarry, or sticky, or have blood or mucous
- severe stomach-area pain or tenderness
- vomiting
- urinating less often than usual
- dizziness
- headache
LIVMARLI in Progressive Familial Intrahepatic Cholestasis
LIVMARLI (maralixibat) is an ileal bile acid transporter inhibitor indicated for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) five years of age and older.
Liver injury. Changes in certain liver tests are common in patients with Alagille syndrome and PFIC but can worsen during treatment. These changes may be a sign of liver injury. In PFIC, this can be serious or may lead to liver transplant or death. Your healthcare provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen), bloating in your stomach area, loss of appetite or bleeding or bruising more easily than normal.
Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain. Your healthcare provider may advise you to monitor for new or worsening stomach problems including stomach pain, diarrhea, blood in your stool or vomiting. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you.
A condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat is common in patients with Alagille syndrome and PFIC but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment and may monitor for bone fractures and bleeding which have been reported as common side effects. Prescribing Information
Connect with experts from the Mirum Access Plus program who can help secure access for patients and families.
GET STARTED
Healthcare Providers:
PLEASE SEE FULL PRESCRIBING INFORMATION FOR HEALTHCARE PROVIDERS
Patients and Families: PLEASE SEE FULL PRESCRIBING INFORMATION FOR PATIENTS
Patients and Families: PLEASE SEE FULL PRESCRIBING INFORMATION FOR PATIENTS
Important Safety Information
LIVMARLI can cause side effects, including:Liver injury. Changes in certain liver tests are common in patients with Alagille syndrome and PFIC but can worsen during treatment. These changes may be a sign of liver injury. In PFIC, this can be serious or may lead to liver transplant or death. Your healthcare provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen), bloating in your stomach area, loss of appetite or bleeding or bruising more easily than normal.
Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain. Your healthcare provider may advise you to monitor for new or worsening stomach problems including stomach pain, diarrhea, blood in your stool or vomiting. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you.
A condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat is common in patients with Alagille syndrome and PFIC but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment and may monitor for bone fractures and bleeding which have been reported as common side effects. Prescribing Information
