Methods for treating cholestasis
Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 μg/kg/day.
1. A method of treating cholestatic pruritus in a subject having Alagille Syndrome (ALGS) comprising administering to the subject maralixibat in an amount of from about 400 μg/kg/day to about 800 μg/kg/day, wherein maralixibat is administered as a liquid pharmaceutical composition comprising about 0.001 mg/mL to about 16 mg/mL of maralixibat.
2. The method of claim 1 , wherein maralixibat is administered in an amount of about 400 μg/kg/day.
3. The method of claim 1 , wherein maralixibat is administered in an amount of 360 μg/kg/day to 400 μg/kg/day.
4. The method of claim 1 , wherein maralixibat is administered once daily (QD).
5. The method of claim 1 , wherein maralixibat is administered once daily in an amount of about 400 μg/kg/day.
6. The method of claim 1 , wherein maralixibat is administered once daily in an amount of 360 μg/kg/day to 400 μg/kg/day.
7. The method of claim 1 , wherein maralixibat is administered for at least 18 weeks.
8. The method of claim 1 , wherein maralixibat is administered for at least 2 years.
9. The method of claim 1 , wherein maralixibat is administered for at least 3 years.
10. The method of claim 1 , wherein the subject is a pediatric subject.
11. The method of claim 1 , wherein the subject is at least 1 year of age.
12. The method of claim 1 , wherein maralixibat is administered prior to ingestion of food.
13. The method of claim 1 , wherein maralixibat is administered orally.
14. The method of claim 1 , wherein the liquid pharmaceutical composition comprises about 10 mg/mL of maralixibat.
15. The method of claim 1 , wherein the liquid pharmaceutical composition is administered orally.
16. The method of claim 1 , wherein the liquid pharmaceutical composition is an oral solution.
17. The method of claim 1 , wherein the liquid pharmaceutical composition is an aqueous solution.