Combination of | |
---|---|
Elagolix | Gonadotropin-releasing hormone receptor antagonist |
Estradiol | Estrogen |
Norethisterone acetate | Progestin |
Clinical data | |
Trade names | Oriahnn |
AHFS/ Drugs.com | Professional Drug Facts |
MedlinePlus | a620042 |
License data | |
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG |
Elagolix/estradiol/norethisterone acetate, sold under the brand name Oriahnn, is a fixed-dose combination medication used to treat heavy menstrual bleeding associated with uterine leiomyomas ( fibroids) in premenopausal women. [1] [2] [3] It contains elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethisterone acetate, a progestin. [1] [2] It is taken by mouth. [1] [2] Oriahnn is co-packaged as a combination of elagolix/estradiol/norethisterone acetate capsules with elagolix capsules. [1]
The most common side effects include hot flushes (sudden feelings of warmth), headache, fatigue and irregular vaginal bleeding. [2]
Fibroids are benign (non-cancerous) muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility. [2] Some women may not experience any symptoms, but many do, including heavy bleeding with periods. [2] Fibroids can occur at any age but are most common in women 35 to 49 years of age. [2] They typically resolve after menopause but are a leading reason for hysterectomy (surgical removal of the uterus) in the United States when they cause severe symptoms. [2]
Elagolix/estradiol/norethisterone acetate is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. [2]
Elagolix/estradiol/norethisterone acetate may cause bone loss over time, and the loss in some women may not be completely recovered after stopping treatment. [2] Because bone loss may increase the risk for fractures, women should not take elagolix/estradiol/norethisterone acetate for more than 24 months. [2]
The drug label for the combination includes a boxed warning about the risk of vascular events (strokes) and thrombotic or thromboembolic disorders (blood clots), especially in women at increased risk for these events. [2]
Elagolix/estradiol/norethisterone acetate was approved for medical use in the United States in May 2020. [2] [4]
The efficacy of elagolix/estradiol/norethisterone acetate was established in two clinical trials in which a total of 591 premenopausal women with heavy menstrual bleeding received the drug or placebo for six months. [2] Heavy menstrual bleeding at baseline was defined as having at least two menstrual cycles with greater than 80 mL (about a third of a cup) of menstrual blood loss (MBL). [2] The primary endpoint was the proportion of women who achieved MBL volume less than 80 mL at the final month and 50% or greater reduction in MBL volume from the start of the study (baseline) to the final month. [2] In the first study, 68.5% of participants who received elagolix/estradiol/norethisterone acetate achieved this endpoint (compared to 8.7% of participants who received placebo). [2] In the second study, 76.5% of participants who received elagolix/estradiol/norethisterone acetate achieved this endpoint (compared to 10.5% of participants who received placebo). [2]
The approval of Oriahnn was granted to AbbVie Inc. [2]
Combination of | |
---|---|
Elagolix | Gonadotropin-releasing hormone receptor antagonist |
Estradiol | Estrogen |
Norethisterone acetate | Progestin |
Clinical data | |
Trade names | Oriahnn |
AHFS/ Drugs.com | Professional Drug Facts |
MedlinePlus | a620042 |
License data | |
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG |
Elagolix/estradiol/norethisterone acetate, sold under the brand name Oriahnn, is a fixed-dose combination medication used to treat heavy menstrual bleeding associated with uterine leiomyomas ( fibroids) in premenopausal women. [1] [2] [3] It contains elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethisterone acetate, a progestin. [1] [2] It is taken by mouth. [1] [2] Oriahnn is co-packaged as a combination of elagolix/estradiol/norethisterone acetate capsules with elagolix capsules. [1]
The most common side effects include hot flushes (sudden feelings of warmth), headache, fatigue and irregular vaginal bleeding. [2]
Fibroids are benign (non-cancerous) muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility. [2] Some women may not experience any symptoms, but many do, including heavy bleeding with periods. [2] Fibroids can occur at any age but are most common in women 35 to 49 years of age. [2] They typically resolve after menopause but are a leading reason for hysterectomy (surgical removal of the uterus) in the United States when they cause severe symptoms. [2]
Elagolix/estradiol/norethisterone acetate is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. [2]
Elagolix/estradiol/norethisterone acetate may cause bone loss over time, and the loss in some women may not be completely recovered after stopping treatment. [2] Because bone loss may increase the risk for fractures, women should not take elagolix/estradiol/norethisterone acetate for more than 24 months. [2]
The drug label for the combination includes a boxed warning about the risk of vascular events (strokes) and thrombotic or thromboembolic disorders (blood clots), especially in women at increased risk for these events. [2]
Elagolix/estradiol/norethisterone acetate was approved for medical use in the United States in May 2020. [2] [4]
The efficacy of elagolix/estradiol/norethisterone acetate was established in two clinical trials in which a total of 591 premenopausal women with heavy menstrual bleeding received the drug or placebo for six months. [2] Heavy menstrual bleeding at baseline was defined as having at least two menstrual cycles with greater than 80 mL (about a third of a cup) of menstrual blood loss (MBL). [2] The primary endpoint was the proportion of women who achieved MBL volume less than 80 mL at the final month and 50% or greater reduction in MBL volume from the start of the study (baseline) to the final month. [2] In the first study, 68.5% of participants who received elagolix/estradiol/norethisterone acetate achieved this endpoint (compared to 8.7% of participants who received placebo). [2] In the second study, 76.5% of participants who received elagolix/estradiol/norethisterone acetate achieved this endpoint (compared to 10.5% of participants who received placebo). [2]
The approval of Oriahnn was granted to AbbVie Inc. [2]