Maralixibat

Generic name
Maralixibat
Brand name
ATC Code
A05AX04
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Maralixibat

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Progressive familial intrahepatic cholestasis (PFIC)
  • Oral
    • ≥ 3 months
      • Initial dose: 285 microg./kg/day in 1 dose
      • Maintenance dose: If needed Increase dose after 1-2 weeks based on effect and tolerance to 570 - 1.140 microg./kg/day in 2 doses. Max: 57 mg/day.
Cholestatic pruritus
  • Oral
    • ≥ 2 months
      • Initial dose: 190 microg./kg/day in 1 dose Increase initial dose after 1 week based on effect and tolerance to.
      • Maintenance dose: Increase initial dose after 1 week based on effect and tolerance to 380 microg./kg/day in 1 dose. Max: 28.5 mg/day.

Renal impaiment in children > 3 months

Because of the propylene glycol content, the recommended maximum dose of Livmarli in patients with moderately impaired renal function (creatinine clearance CrCl ≥ 30 and < 60 ml/min) is 570 mcg/kg/dag. Livmarli should not be used in patients with severely impaired renal function.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The safety profile of maralixibat is consistent across all indications and age groups.

Very common (> 10%): abdominal pain and diarrhea (median duration < 1 week), diarrhea.
Common (1-10%): rise in ALAT and ASAT, in part with an increase in bilirubin.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Check:

  • Before treatment: the values of fat-soluble vitamins (A, D and E) and of the INR. If these vitamins are deficient, additional therapy should be prescribed;
  • liver function values before and during treatment. Increases in ALAT (without increases in bilirubin) have been observed; their clinical significance is not known;
  • during episodes of diarrhea on adequate hydration.

Conditions, drugs or surgical procedures that affect gastrointestinal motility or enterohepatic circulation of bile acids may affect the efficacy of maralixibat.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

BILE THERAPY

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Bile acids and derivatives
A05AA02
Other drugs for bile therapy
A05AX05
BILE ACIDS AND DERIVATIVES
A05AA02

Reference

  1. Mirum Pharmaceuticals International B.V., SmPC Livmarli (EU/1/22/1704/001) Rev 7; 12-7-2024, www.emea.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose