FIRST AND ONLY FDA-APPROVED TREATMENT
For patients with Alagille syndrome

AIM TO DITCH THE ITCH

LIVMARLI is the first and only FDA-approved treatment for cholestatic pruritus in Alagille syndrome1
Significant improvements in cholestatic pruritus
Significant improvements in cholestatic pruritus »
Significant improvements in cholestatic pruritus from baseline were achieved as early as Week 3 and maintained through 1 year (P<0.0001); for patients who remained on treatment with LIVMARLI in the open-label extension (n=15), cholestatic pruritus responses compared with baseline were durable through nearly 4 years.2,3
Backed by >5 years of safety data
Backed by >5 years of safety data* »
LIVMARLI has a well-characterized safety and tolerability profile for cholestatic pruritus in patients with Alagille syndrome who are ≥1 year old.1,5
*The majority of exposure occurred without a placebo control in open-label extensions.
Proven mechanism of action
Proven mechanism of action »
LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor that reduces serum bile acid (sBA) levels in the body by interrupting recirculation of bile acids to the liver and increasing their excretion in feces.1,2,4
Once-daily dosing
Once-daily dosing »
The recommended dose (380 mcg/kg) of LIVMARLI is administered orally once daily approximately 30 minutes before the first meal of the day.1
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Itch✓ App and
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WELCOME TO THE LIVER LEAGUE INFORMATION BOOTH

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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.