Methods of Administering Elagolix
AssigneeAbbVie Inc.
InventorsMohamad Shebley, Ling Cheng, Pooja Manchandani
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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) or a CYP3A4 substrate (e.g., ethinyl estradiol and/or levonorgestrel).
Claims31
1-12. (canceled)
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 200 mg of elagolix free acid twice daily;
- prior to initiating administration of elagolix sodium, (a) discontinuing treatment with an estrogen-containing contraceptive and/or (b) limiting treatment with a combined oral contraceptive comprising ethinyl estradiol to a dose of 20 mcg ethinyl estradiol;
- and
- continuing said oral administration for a time period as needed to manage the moderate to severe pain associated with endometriosis.
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 (i) in an amount equivalent to 150 mg of elagolix free acid once daily or (ii) in an amount equivalent to 200 mg of elagolix free acid twice daily;
- wherein the patient further receives a contraceptive comprising levonorgestrel according to a contraceptive dosing schedule.
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 (i) in an amount equivalent to 150 mg of elagolix free acid once daily or (ii) in an amount equivalent to 200 mg of elagolix free acid twice daily;
- and
- continuing said oral administration for a time period as needed to manage the moderate to severe pain associated with endometriosis;
- wherein the patient uses non-hormonal contraception during treatment with elagolix sodium and for more than 7 days after discontinuing elagolix sodium.
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;
- and
- continuing said oral administration for a time period as needed to manage the heavy menstrual bleeding associated with uterine leiomyomas (fibroids);
- wherein the patient uses non-hormonal contraception during treatment with elagolix sodium and for more than 7 days after discontinuing elagolix sodium.
Dependencies are inferred from the claim text.