A gonotropin-releasing hormone antagonist for pain due to endometriosis.

It is an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones.

It is effective in reducing heavy menstrual bleeding in women with uterine fibroids.

Approved as an oral combination of elagolix, estradiol, and norethindrone acetate capsules for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Marketed as OrlIssa.

Half to 3/4 of patients had reduce menstrual pain compared with 20% in a placebo group.

Can be taken for up to 24 months at 150 mg per day and up to six months at the 200 mg dose taking twice daily.

Contraindicated in pregnancy.

Has is associated with  dependent decrease in bone mineral density.

Adverse effects include hot flashes and elevated serum lipids

ELARIS UF-I and ELARIS UF-II,1 elagolix and E2/NETA achieved the primary endpoint of clinically meaningful reduction in bleeding (defined as the proportion of women who achieved both at least a 50% reduction in menstrual blood loss at final month of treatment and a total menstrual blood loss amount of less than 80 ml), compared with placebo in final month of study for patients.



Seven of 10 women no longer experienced heavy menstrual bleeding versus 1 of 10 women on placebo .



The therapy also reduced heavy menstrual bleeding due to uterine fibroids by 50% within the first month of use.



Use of elagolix and E2/NETA should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.1,2



The most common adverse effects of the combination drug were hot flushes, headache, fatigue and irregular vaginal bleeding. 



Drug label for elagolix and E2/NETA includes a Boxed Warning about the risk of strokes and  thrombotic or thromboembolic disorders.



The therapy is taken twice daily.


Leave a Reply

Your email address will not be published. Required fields are marked *