Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.14 Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.14 Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).14 In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).14 The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).14
It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.
AUB caused by fibroids is a common problem in gyn practice
There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●
Fibroids: Impact of age and race
Black women are more likely to develop fibroids and experience more severe fibroid symptoms. Obstetrician-gynecologists are experts in the diagnosis and treatment of fibroids. We play a key role in partnering with Black women to reduce fibroid disease burden.
Factors that increase the risk of developing fibroids include: increasing age, Black race, nulliparity, early menarche (<10 years of age), obesity, and consumption of red meat.1 The Nurses Health Study II is the largest prospective study of the factors that influence fibroid development.2 A total of 95,061 premenopausal nurses aged 25 to 44 years were followed from September 1989 through May 1993. Review of a sample of medical records demonstrated that the nurses participating in the study were reliable reporters of whether or not they had been diagnosed with fibroids. Based on a report of an ultrasound or hysterectomy diagnosis, the incidence rate for fibroids increased with age. Incidence rate per 1,000 women-years was 4.3 (age 25 to 29 years), 9.0 (30 to 34 years), 14.7 (age 35 to 39 years), and 22.5 (40 to 44 years). Compared with White race, Black race (but not Hispanic ethnicity or Asian race) was associated with an increased incidence of fibroids. Incidence rate per 1,000 women-years was 12.5 (White race), 37.9 (Black race), 14.5 (Hispanic ethnicity), and 10.4 (Asian race). The risk of developing fibroids was 3.25 times (95% CI, 2.71 to 3.88) greater among Black compared with White women after controlling for body mass index, age at first birth, years since last birth, history of infertility, age at first oral contraceptive use, marital status, and current alcohol use.2
Other epidemiology studies also report an increased incidence of fibroids among Black women.3,4 The size of the uterus, the size and number of fibroids, and the severity of fibroid symptoms are greater among Black versus White women.5,6 The molecular factors that increase fibroid incidence among Black women are unknown. Given the burden of fibroid disease among Black women, obstetrician-gynecologists are best positioned to ensure early diagnosis and to develop an effective follow-up and treatment plan for affected women.
References
1. Stewart EA, Laughlin-Tommaso SK, Catherino WH, et al. Uterine fibroids. Nat Rev Dis Primers. 2016;2:16043.
2. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973.
3. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
4. Brett KM, Marsh JV, Madans JH. Epidemiology of hysterectomy in the United States: demographic and reproductive factors in a nationally representative sample. J Womens Health. 1997;6:309-316.
5. Peddada SD, Laughlin SK, Miner K, et al. Growth of uterine leiomyomata among premenopausal black and white women. Proc Natl Acad Sci USA. 2008;105:1988719892.
6. Huyck KL, Panhuysen CI, Cuenco KT, et al. The impact of race as a risk factor for symptom severity and age at diagnosis of uterine leiomyomata among affected sisters. Am J Obstet Gynecol. 2008;198:168.e1-e9.