Compositions and methods for administering paltusotine to patients with hepatic impairment
Provided are compositions and methods for administering paltusotine, or a pharmaceutically acceptable salt thereof, to a patient having hepatic impairment.
1. A method comprising administering a therapeutically effective amount of paltusotine, or a pharmaceutically acceptable salt thereof, to a patient, wherein the patient has hepatic impairment, and wherein the therapeutically effective amount of paltusotine, or a pharmaceutically acceptable salt thereof, is the same amount that would be administered to a patient who does not have hepatic impairment, wherein the paltusotine is administered to the patient to treat acromegaly, carcinoid syndrome and/or neuroendocrine tumor.
2. A method comprising:
(a) administering to a patient a therapeutically effective amount of paltusotine, or a pharmaceutically acceptable salt thereof;
(b) subsequently determining that the patient has hepatic impairment; and
(c) administering the same therapeutically effective amount of paltusotine, or a pharmaceutically acceptable salt thereof, to the patient without dose adjustment, wherein the paltusotine is administered to the patient to treat acromegaly, carcinoid syndrome and/or neuroendocrine tumor.
3. The method of claim 1 , wherein the patient has mild, moderate, or severe hepatic impairment.
4. The method of claim 3 , wherein the patient has mild hepatic impairment.
5. The method of claim 3 , wherein the patient has moderate hepatic impairment.
6. The method of claim 3 , wherein the patient has severe hepatic impairment.
7. The method of claim 1 , wherein the patient has a Child-Pugh Score of 5-6, 7-9, or 10-15.
8. The method of claim 7 , wherein the patient has a Child-Pugh Score of 4-5.
9. The method of claim 7 , wherein the patient has a Child-Pugh Score of 6-8.
10. The method of claim 7 , wherein the patient has a Child-Pugh Score of 10-15.
11. The method of claim 1 , wherein the patient has acromegaly.
12. The method of claim 11 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 40 mg of paltusotine free base.
13. The method of claim 11 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 60 mg of paltusotine free base.
14. The method of claim 2 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered to the patient to treat acromegaly.
15. The method of claim 1 , wherein the patient has carcinoid syndrome and/or NETs.
16. The method of claim 15 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 40 mg of paltusotine free base.
17. The method of claim 15 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 80 mg of paltusotine free base.
18. The method of claim 15 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 120 mg of paltusotine free base.
19. The method of claim 2 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered to the patient to treat carcinoid syndrome and/or NETs.
20. The method of claim 1 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered daily.
21. The method of claim 1 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered once daily.
22. The method of claim 1 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered orally.
23. The method of claim 1 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in one or more oral dosage forms.
24. The method of claim 23 , wherein the oral dosage form is a tablet.
25. The method of claim 1 , wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is a hydrochloride salt of paltusotine.
26. The method of claim 25 , wherein the hydrochloride salt of paltusotine is amorphous.
27. The method of claim 1 , wherein the patient with hepatic impairment has equivalent exposure of paltusotine free base as in a patient with normal hepatic function who is administered the same amount of paltusotine, or a pharmaceutically acceptable salt thereof.