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LIVMARLI is a brand name for Maralixibat, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LIVMARLI® (maralixibat oral solution and tablets) is indicated for: • the treatment of cholestatic pruritus in patients aged 12 months or older with Alagille syndrome (ALGS). • the treatment of cholestatic pruritus in patients aged 12 months or older with progressive familial intrahepatic cholestasis (PFIC).…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Hepatic biomarkers Product Monograph January 2026 LIVMARLI (maralixibat oral solution, maralixibat tablets) Page 5 of 37 Protected B / Protégé B • Baseline values for hepatic biomarkers including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), total and direct bilirubin, and International Normalized Ratio (INR) should be established.
• Serum ALT, serum AST, total and direct bilirubin, and INR, should be monitored during treatment with LIVMARLI. • Should increases occur in the absence of other causes or expected progression of underlying disease, dose reduction or interruption of LIVMARLI treatment may be considered.
Once the liver test abnormalities either return back to baseline values or stabilize at a new baseline value, consider restarting LIVMARLI at the last tolerated dose, and increase the dose as tolerated with close monitoring of hepatic biomarkers.
4 ADVERSE REACTIONS, Abnormal Laboratory Findings, Hepatic Biomarkers). • The efficacy and safety of LIVMARLI should be monitored when switching from the oral solutions to the tablets. 5 mg/mL for the treatment of pruritus in ALGS, and use LIVMARLI Oral Solution 19 mg/mL for the treatment of pruritus in PFIC.
5 mg/mL for PFIC as this may result in significantly higher propylene glycol levels with the potential for propylene glycol toxicity and overdose. LIVMARLI tablets can be used for treatment of both ALGS and PFIC in patients weighing 22 kg and above who can swallow tablets Tablets should not be crushed.
Tablets are not interchangeable with the oral solutions based on the dosing by weight guidelines (Tables 1 through 4). Patients may be switched from LIVMARLI oral solution to LIVMARLI tablets to accommodate change of body weight (22 kg and above) and ability to swallow tablets or from LIVMARLI tablets to LIVMARLI oral solution due to patient preference or tolerability.
Special attention should be given to the accurate selection of the dose based on the appropriate LIVMARLI dosing table. Recommended Dose for Alagille Syndrome The recommended maintenance dosage of LIVMARLI is 380 mcg/kg taken once daily in the morning.
LIVMARLI should be initiated at a dose of 190 mcg/kg orally once daily. If tolerated, LIVMARLI may be increased to 380 mcg/kg once daily after one week. 5 mg per day for LIVMARLI oral solution. For LIVMARLI tablets, the maximum daily dose for patients above 66 kg is 30 mg.
, Abnormal Laboratory Findings, Hepatic Biomarkers). • The efficacy and safety of LIVMARLI should be monitored when switching from the oral solutions to the tablets. 5 mg/mL for the treatment of pruritus in ALGS, and use LIVMARLI Oral Solution 19 mg/mL for the treatment of pruritus in PFIC.
5 mg/mL for PFIC as this may result in significantly higher propylene glycol levels with the potential for propylene glycol toxicity and overdose. LIVMARLI tablets can be used for treatment of both ALGS and PFIC in patients weighing 22 kg and above who can swallow tablets Tablets should not be crushed.
Tablets are not interchangeable with the oral solutions based on the dosing by weight guidelines (Tables 1 through 4). Patients may be switched from LIVMARLI oral solution to LIVMARLI tablets to accommodate change of body weight (22 kg and above) and ability to swallow tablets or from LIVMARLI tablets to LIVMARLI oral solution due to patient preference or tolerability.
Special attention should be given to the accurate selection of the dose based on the appropriate LIVMARLI dosing table. Recommended Dose for Alagille Syndrome The recommended maintenance dosage of LIVMARLI is 380 mcg/kg taken once daily in the morning.
LIVMARLI should be initiated at a dose of 190 mcg/kg orally once daily. If tolerated, LIVMARLI may be increased to 380 mcg/kg once daily after one week. 5 mg per day for LIVMARLI oral solution. For LIVMARLI tablets, the maximum daily dose for patients above 66 kg is 30 mg.
5 mg/mL for the treatment of ALGS. 5 mg/mL oral solution) and Table 2 (tablet). 5 mg/mL for the treatment of ALGS. 5 mg/mL Oral Solution 10 mg 33 to 43 15 mg 44 to 65 10 mg 20 mg 66 or higher 15 mg 30 mg There are limited data currently available regarding the long-term use of maralixibat in patients with Alagille Syndrome.
, Hepatic/Biliary/Pancreatic, and 8.
, variceal hemorrhage, ascites, hepatic encephalopathy). LIVMARLI is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg/mL for the treatment of ALGS. 5 mg/mL oral solution) and Table 2 (tablet). 5 mg/mL for the treatment of ALGS. 5 mg/mL Oral Solution 10 mg 33 to 43 15 mg 44 to 65 10 mg 20 mg 66 or higher 15 mg 30 mg There are limited data currently available regarding the long-term use of maralixibat in patients with Alagille Syndrome.
Because Alagille Syndrome is a rare, intractable genetic disease, long-term therapy is expected. Periodic re-assessment, including dosing recalculation as the patient grows, is required. Recommended Dose for Progressive Familial Intrahepatic Cholestasis The recommended dosage is 570 mcg/kg twice daily 30 minutes before a meal.
The starting dose is 285 mcg/kg orally once daily (QD) in the morning and should be increased to 285 mcg/kg twice daily (BID), 428 mcg/kg twice daily, and then to 570 mcg/kg twice daily, as tolerated. The maximum daily dose volume for patients above 35 kg is 2 ml (38 mg) for LIVMARLI oral solution.
For LIVMARLI tablets the maximum daily dose for patients above 44 kg is 40 mg. Refer to the dosing by weight guidelines presented in Table 3 (19 mg/mL oral solution) and Table 4 (tablet). Product Monograph January 2026 LIVMARLI (maralixibat oral solution, maralixibat tablets) Page 7 of 37 Protected B / Protégé B LIVMARLI Oral Solution Use LIVMARLI Oral Solution 19 mg/mL for the treatment of pruritus in PFIC.
0 LIVMARLI Tablets Tablets should be used in patients able to swallow tablets.
Table 4:
Dose by Patient Weight for LIVMARLI Tablets: PFIC Patient Weight (kg) 285 mcg/kg QD or BID 428 mcg/kg BID 570 mcg/kg BID 22 to 29 See […]
Because Alagille Syndrome is a rare, intractable genetic disease, long-term therapy is expected. Periodic re-assessment, including dosing recalculation as the patient grows, is required. Recommended Dose for Progressive Familial Intrahepatic Cholestasis The recommended dosage is 570 mcg/kg twice daily 30 minutes before a meal.
The starting dose is 285 mcg/kg orally once daily (QD) in the morning and should be increased to 285 mcg/kg twice daily (BID), 428 mcg/kg twice daily, and then to 570 mcg/kg twice daily, as tolerated. The maximum daily dose volume for patients above 35 kg is 2 ml (38 mg) for LIVMARLI oral solution.
For LIVMARLI tablets the maximum daily dose for patients above 44 kg is 40 mg. Refer to the dosing by weight guidelines presented in Table 3 (19 mg/mL oral solution) and Table 4 (tablet). Product Monograph January 2026 LIVMARLI (maralixibat oral solution, maralixibat tablets) Page 7 of 37 Protected B / Protégé B LIVMARLI Oral Solution Use LIVMARLI Oral Solution 19 mg/mL for the treatment of pruritus in PFIC.
0 LIVMARLI Tablets Tablets should be used in patients able to swallow tablets.
Table 4:
Dose by Patient Weight for LIVMARLI Tablets: PFIC Patient Weight (kg) 285 mcg/kg QD or BID 428 mcg/kg BID 570 mcg/kg BID 22 to 29 See Table 3 for 19 mg/mL Oral Solution 10 mg 15 mg 30 to 43 10 mg 15 mg 20 mg 44 to 65 15 mg 20 mg 20 mg 66 or higher 20 mg 20 mg 20 mg Geriatrics The safety and efficacy in patients 65 years of age and older have not been established.
Product Monograph January 2026 LIVMARLI (maralixibat oral solution, maralixibat tablets) Page 8 of 37 Protected B / Protégé B Renal impairment Maralixibat has not been studied in patients with renal impairment or end-stage renal disease (ESRD) requiring hemodialysis.
3 CLINICAL PHARMACOLOGY, Pharmacokinetics). Hepatic impairment LIVMARLI is contraindicated in patients with prior or active hepatic decompensation events. Maralixibat has not been sufficiently studied in patients with liver impairment.
Due to minimal absorption, no dose adjustment is required for patients with hepatic impairment. 3 CLINICAL PHARMACOLOGY, Pharmacokinetics). Monitor patients with liver impairment for signs of potential propylene glycol toxicity, […]