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Help your patients
 with PFIC
 rise above cholestatic pruritus so they can

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>850 PATIENTS1
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LIVMARLI is FDA approved for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) who are ≥5 years of age1

Limitations of Use: LIVMARLI is not recommended in a subgroup of patients with PFIC type 2 with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump-3 (BSEP-3) protein.

NOW APPROVED

LIVMARLI is FDA approved for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) who are ≥5 years of age1

Limitations of Use: LIVMARLI is not recommended in a subgroup of patients with PFIC type 2 with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump-3 (BSEP-3) protein.

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>850
patients have used LIVMARLI to battle bile acid buildup.1,2,6*
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*Number includes all patients with cholestatic pruritus in Alagille syndrome treated with LIVMARLI in clinical studies, as well as those treated in the United States commercially and through the expanded access program.

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Indication

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients who are 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC).

Limitations of Use: LIVMARLI is not recommended in a subgroup of patients with PFIC type 2 with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump-3 (BSEP-3) protein.

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 (DILI).

In the PFIC trial, treatment-emergent hepatic decompensation events and elevations of liver tests or worsening of liver tests occurred. Two patients experienced DILI attributable to LIVMARLI. Two additional patients experienced DILI in the open-label extension portion of the trial. Of these 4 patients, 1 patient required liver transplant and another patient died.

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. Permanently discontinue LIVMARLI if a patient experiences the following: persistent or recurrent liver test abnormalities, clinical hepatitis upon rechallenge, or a hepatic decompensation event.

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 LIVMARLI dosing if a patient experiences persistent diarrhea or diarrhea with bloody stool, vomiting, dehydration requiring treatment, or fever.

Fat-Soluble Vitamin Deficiency: Patients can have fat-soluble vitamin (FSV) deficiency (vitamins A, D, E, and K) at baseline, and LIVMARLI may adversely affect absorption of FSV. Treatment-emergent bone fracture events have been observed more frequently with patients treated with LIVMARLI compared with patients treated with placebo. 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.

Adverse Reactions

The most common adverse reactions are diarrhea, FSV, abdominal pain, liver test abnormalities, hematochezia, 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 twice daily 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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Indication

LIVMARLI is indicated for the treatment of cholestatic pruritus in patients who are 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC).

Limitations of Use: LIVMARLI is not recommended in a subgroup of patients with PFIC type 2 with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump-3 (BSEP-3) protein.

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 (DILI).

In the PFIC trial, treatment-emergent hepatic decompensation events and elevations of liver tests or worsening of liver tests occurred. Two patients experienced DILI attributable to LIVMARLI. Two additional patients experienced DILI in the open-label extension portion of the trial. Of these 4 patients, 1 patient required liver transplant and another patient died.

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. Permanently discontinue LIVMARLI if a patient experiences the following: persistent or recurrent liver test abnormalities, clinical hepatitis upon rechallenge, or a hepatic decompensation event.

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 LIVMARLI dosing if a patient experiences persistent diarrhea or diarrhea with bloody stool, vomiting, dehydration requiring treatment, or fever.

Fat-Soluble Vitamin Deficiency: Patients can have fat-soluble vitamin (FSV) deficiency (vitamins A, D, E, and K) at baseline, and LIVMARLI may adversely affect absorption of FSV. Treatment-emergent bone fracture events have been observed more frequently with patients treated with LIVMARLI compared with patients treated with placebo. 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.

Adverse Reactions

The most common adverse reactions are diarrhea, FSV, abdominal pain, liver test abnormalities, hematochezia, 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 twice daily 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.