Methods of Administering Elagolix
AssigneeAbbVie Inc.
InventorsFarah N. Ali, Sheetal P. Dharia, Nael M. Mostafa, Ahmed Nader, Akshanth R. Polepally, Mohamad Shebley
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Abstract
The present disclosure relates to the use of GnRH receptor antagonists for the treatment of endometriosis, uterine fibroids, polycystic ovary syndrome (PCOS), or adenomyosis. In particular, the present disclosure describes methods for treating such gynecological disorders, where the methods involve administration of elagolix and may further involve co-administration of a CYP2B6 substrate (e.g., bupropion) or a CYP2C19 substrate (e.g., omeprazole).
Claims24
A method for treating a gynecological disorder, the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein the patient concomitantly receives bupropion, wherein the bupropion is administered without an adjustment to a recommended bupropion dosing schedule.
A method for treating a gynecological disorder, the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein the patient concomitantly receives omeprazole, wherein the omeprazole is administered without an adjustment to a recommended omeprazole dosing schedule.
A method for treating a gynecological disorder, the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein the patient concomitantly receives omeprazole for a pathologic hypersecretory condition, wherein the omeprazole is administered according to a modified omeprazole dosing schedule, such modified omeprazole dosing schedule comprising a reduced omeprazole dose and/or a reduced frequency of omeprazole administration relative to a recommended omeprazole dosing schedule for pathologic hypersecretory conditions.
A method for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids), the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein elagolix sodium is administered in an amount equivalent to 300 mg of elagolix free acid twice daily;
- wherein the patient receives a dose of 150 mg of bupropion;
- and wherein:
- (i) a bupropion Cmax ratio, which compares (A) bupropion Cmax when co-administered in the presence of elagolix to (B) bupropion Cmax when administered alone, is 1.246 with a 90% confidence interval of 1.104-1.407;
- and/or
- (ii) a bupropion AUCinf ratio, which compares (A) bupropion AUCinf when co-administered in the presence of elagolix to (B) bupropion AUCinf when administered alone, is 0.965 with a 90% confidence interval of 0.910-1.023.
A method for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids), the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein elagolix sodium is administered in an amount equivalent to 300 mg of elagolix free acid twice daily;
- wherein the patient receives a dose of 40 mg of omeprazole;
- and wherein:
- (i) an omeprazole Cmax ratio, which compares (A) omeprazole Cmax when co-administered in the presence of elagolix to (B) omeprazole Cmax when administered alone, is 1.95 with a 90% confidence interval of 1.50-2.53;
- and/or
- (ii) an omeprazole AUCinf ratio, which compares (A) omeprazole AUCinf when co-administered in the presence of elagolix to (B) omeprazole AUCinf when administered alone, is 1.78 with a 90% confidence interval of 1.39-2.27.
A method for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids), the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein elagolix sodium is administered in an amount equivalent to 300 mg of elagolix free acid twice daily;
- further wherein said patient has a co-morbid Zollinger-Ellison syndrome and said patient receives:
- (a) a reduced starting daily dose of less than 60 mg of omeprazole administered once a day;
- (b) a reduced daily dose of less than 80 mg of omeprazole administered once a day, twice a day or three times a day;
- or
- (c) a reduced daily dose of less than 120 mg of omeprazole administered three times a day.
A method for management of moderate to severe pain associated with endometriosis, the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein elagolix sodium is administered in an amount equivalent to 150 mg of elagolix free acid once a day or 200 mg of elagolix free acid twice a day;
- further wherein said patient has a co-morbid Zollinger-Ellison syndrome and said patient receives:
- (a) a reduced starting daily dose of less than 60 mg of omeprazole administered once a day;
- (b) a reduced daily dose of less than 80 mg of omeprazole administered once a day, twice a day or three times a day;
- or
- (c) a reduced daily dose of less than 120 mg of omeprazole administered three times a day.
A method for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids), the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein elagolix sodium is administered in an amount equivalent to 300 mg of elagolix free acid twice daily;
- further wherein said patient has a co-morbid Zollinger-Ellison syndrome and said patient receives a drug that is metabolized by CYP2C19 pathway, such that said drug is
- (a) lansoprazole, and the reduced daily dose of lansoprazole is less than 60 mg administered once a day;
- (b) omeprazole, and the reduced daily dose of omeprazole is between 10 mg to less than 360 mg administered daily;
- (c) pantoprazole, and the reduced daily dose of pantoprazole is less than 40 mg twice a day;
- (d) rabeprazole, and the reduced daily dose of rabeprazole is less than 60 mg administered once a day;
- or
- esomoprazole, and the reduced daily dose of esomoprazole is less than 40 mg twice a day.
A method for management of moderate to severe pain associated with endometriosis, the method comprising:
- orally administering to a patient in need thereof elagolix sodium, wherein elagolix sodium is administered in an amount equivalent to 150 mg of elagolix free acid once a day or 200 mg of elagolix free acid twice a day;
- further wherein said patient has a co-morbid Zollinger-Ellison syndrome and said patient receives a drug that is metabolized by CYP2C19 pathway, such that said drug is:
- (a) lansoprazole, and the reduced daily dose of lansoprazole is less than 60 mg administered once a day;
- (b) omeprazole, and the reduced daily dose of omeprazole is between 10 mg to less than 360 mg administered daily;
- (c) pantoprazole, and the reduced daily dose of pantoprazole is less than 40 mg twice a day;
- (d) rabeprazole, and the reduced daily dose of rabeprazole is less than 60 mg administered once a day;
- or
- (e) esomoprazole, and the reduced daily dose of esomoprazole is less than 40 mg twice a day.
Dependencies are inferred from the claim text.