THROMBOPOIETINN RECEPTOR AGONIST DOSAGE REGIMEN

Claims

1. A method of administering germopag or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein the patient has mild hepatic impairment, said method comprising administering to the patient having mild hepatic impairment a therapeutically effective amount of germopag or a pharmaceutically acceptable salt thereof, wherein the initial dose of germopag or a pharmaceutically acceptable salt thereof is not adjusted compared to the initial dose administered to a patient with normal liver function.

2. A method of administering germopag or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein the patient has moderate hepatic impairment, said method comprising administering to the patient having moderate hepatic impairment a therapeutically effective amount of germopag or a pharmaceutically acceptable salt thereof, wherein the initial dose of germopag or a pharmaceutically acceptable salt thereof is less than the initial dose administered to a patient with normal liver function or with mild liver impairment.

3. The method according to item 2, where the initial dose of herombopag or its pharmaceutically acceptable salt administered to a patient with moderate hepatic impairment is 10-90% less than the initial dose administered to a patient with normal hepatic function or with mild hepatic impairment; preferably, the initial dose of herombopag or its pharmaceutically acceptable salt administered to a patient with moderate hepatic impairment is 20-80% less than the initial dose administered to a patient with normal hepatic function or with mild hepatic impairment; more preferably, the initial dose of herombopag or its pharmaceutically acceptable salt administered to a patient with moderate hepatic impairment is 30-70% less than the initial dose administered to a patient with normal hepatic function or with mild hepatic impairment; Most preferably, the initial dose of herombopag or its pharmaceutically acceptable salt administered to a patient with moderate hepatic impairment is 40-60% less than the initial dose administered to a patient with normal hepatic function or with mild hepatic impairment.

4. The method of claim 2, wherein the initial dose of herombopag or a pharmaceutically acceptable salt thereof administered to a patient with moderate hepatic impairment is 50% less than the initial dose administered to a patient with normal liver function or with mild liver impairment.

5. A method of administering germopag or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein administration of a dose of germopag or a pharmaceutically acceptable salt thereof to a patient with mild, moderate or severe hepatic impairment results in greater exposure than administration of the dose to a patient with normal hepatic function.

6. The method according to item 5, where the degree of impact is determined by C max or AUC 0-∞ .

7. The method according to any of paragraphs 5, 6, where a therapeutically effective amount of germopag or a pharmaceutically acceptable salt thereof is administered to a patient with mild hepatic impairment, wherein administration of germopag to a patient with mild hepatic impairment results in an AUC 0-∞ , which is 10-50% greater than AUC 0-∞ , obtained by administering herombopag to a patient with normal liver function; preferably, AUC 0-∞ Herombopagus is 15-30% larger; more preferably, AUC 0-∞ Herombopagus is 20-25% larger.

8. The method according to any of paragraphs 5, 6, where a therapeutically effective amount of germopag or a pharmaceutically acceptable salt thereof is administered to a patient with moderate hepatic impairment, wherein administration of germopag to a patient with moderate hepatic impairment results in an AUC 0-∞ , which is 30-130% greater than AUC 0-∞ , obtained by administering herombopag to a patient with normal liver function; preferably, AUC 0-∞ Herombopagus is 30-100% larger; more preferably, AUC 0-∞ Herombopagus is 50-100% larger.

9. The method according to any one of claims 1-8, wherein the patient requires administration of herombopag or a pharmaceutically acceptable salt thereof to achieve and maintain a platelet count at a level of 50⋅10 9 / l or more.

10. The method according to any one of claims 1-8, wherein germopag or a pharmaceutically acceptable salt thereof is administered to a patient for the treatment of thrombocytopenia; preferably, the thrombocytopenia is selected from the group consisting of thrombocytopenia in a patient caused by immune thrombocytopenia, hypoplastic anemia, severe hypoplastic anemia, chronic liver disease or chemotherapy.

11. The method according to any one of claims 1-10, wherein the herombopag or a pharmaceutically acceptable salt thereof is the diethanolamine salt of herombopag.

12. The method according to any one of claims 1 to 11, wherein herombopag or a pharmaceutically acceptable salt thereof is administered in a dose of 1 to 30 mg, preferably 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg.

13. The method according to any one of claims 1-12, wherein herombopag or a pharmaceutically acceptable salt thereof is administered in the form of a pharmaceutical composition.

14. The method of claim 13, wherein the composition comprises a therapeutically effective amount of germopag or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier.