Active Ingredient: Maralixibat
Maralixibat is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients 3 months of age and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in months is ≥ 3, oral, 285 micrograms maralixibat, once daily, over the duration of 1 to 2 weeks. Afterwards, in case that patient age in months is ≥ 3, oral, 285 micrograms maralixibat, 1 to 2 times daily, over the duration of 1 to 2 weeks. Afterwards, in case that patient age in months is ≥ 3, oral, between 285 micrograms maralixibat and 570 micrograms maralixibat, 1 to 2 times daily.
The starting dose is 285 mcg/kg once daily (QD) and may be increased after 1-2 weeks to 285 mcg/kg twice daily (BID, morning and evening). After 1-2 weeks, the dose can be increased to 570 mcg/kg twice daily if clinically indicated, as tolerated. In case of poor tolerability, dose reduction or treatment interruption should be considered. Renewed dose-escalation can be attempted as tolerated.
Alternative treatment should be considered in patients for whom no treatment benefit can be established following 3 months of continuous daily treatment with maralixibat.
If a dose is missed, the dose should be omitted, and the original dose schedule resumed with the next scheduled intake.
Maralixibat is administered orally via an oral syringe by a caregiver or the patient, before (up to 30 minutes) or with a meal, in the morning for once daily dosing, or in the morning and evening for twice daily dosing.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.