Am Fam Physician. 2021;103(8):505-506
Author disclosure: No relevant financial affiliations.
The elagolix, estradiol, and norethindrone kit (Oriahnn) is labeled for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal patients. Elagolix is a gonadotropin-releasing hormone receptor antagonist that reduces fibroid-associated bleeding by causing a reversible rapid suppression of gonadotropins and ovarian sex hormones. Estradiol and norethindrone are a hormonal add-back therapy used to replace the reduced levels of endogenous hormones and offset the consequent decrease in bone mineral density (BMD).
| Drug | Dosage | Dose form | Cost* |
|---|---|---|---|
| Elagolix, estradiol, and norethindrone kit (Oriahnn) | Specific capsules are taken in the morning and evening | Morning capsule: 300-mg elagolix, 1-mg estradiol, and 0.5-mg norethindrone Evening capsule: 300-mg elagolix | $1,020 |
Safety
Elagolix may cause duration-dependent decreases in BMD, which can increase the risk of fracture and may not be reversible. Patients should have a baseline BMD measurement before beginning treatment; those with osteoporosis should not take Oriahnn.1 Use of Oriahnn should be limited to 24 months because of the risk of continued bone loss. Contraindications are similar to those of oral contraceptives and include pregnancy, current or previous thromboembolic events, smoking in those older than 35 years, current or previous breast cancer, and uncontrolled hypertension or liver disease. In clinical studies, significant elevations in hepatic alanine transaminase and aspartate transaminase levels occurred in 1% of patients, but returned to baseline within four months after reaching peak levels.1 Patients should be instructed to report any symptoms of liver injury, such as jaundice. Those who are also taking digoxin, midazolam, rosuvastatin (Crestor), or high-dose omeprazole (Prilosec) may need dosing adjustments of these medications.1
Tolerability
About 10% of patients who begin treatment with Oriahnn will discontinue use because of adverse effects. Metrorrhagia has been shown to occur in about 5% of patients, and more than 20% will experience hot flashes.1
Effectiveness
Oriahnn was evaluated in two six-month placebo-controlled trials of 790 premenopausal patients who had heavy menstrual bleeding associated with uterine fibroids.2 The median age of participants was 43 years, and 68% were Black. Based on the results of these studies, Oriahnn will produce a 50% or greater reduction in menstrual blood volume in 68.5% of patients, compared with 8.7% of those treated with placebo (number needed to treat [NNT] = 2). The effect on mean menstrual blood loss volume starts in the first month and continues over months 2 through 6. By six months, 57% of patients will experience suppression of bleeding. Among those with anemia (i.e., hemoglobin level less than 10.4 g per dL [104 g per L]), treatment with Oriahnn will result in an increase in hemoglobin of 2 g per dL (20 g per L) over six months in 62% of patients vs. 16% of those treated with placebo (NNT = 2). Patients treated with Oriahnn reported lower symptom severity and better quality of life. The medication has not been compared directly with other treatments for fibroid-related menstrual bleeding.
Price
A 28-day supply of Oriahnn costs approximately $1,020. This is similar in price to selective progesterone receptor modulators such as leuprolide (Lupron), which costs about $810 for a 28-day supply. Oriahnn is significantly more expensive than oral contraceptives and nonsteroidal anti-inflammatory drugs, which cost about $15 per month.
Simplicity
Distinct morning and evening capsules of Oriahnn should be taken as labeled at the same time each day, with or without food. If a dose is missed and no more than four hours have passed since a capsule is usually taken, the patient should take the missed dose and take the next dose at the usual time. If more than four hours have passed, the patient should skip the missed dose and take the next dose at the usual time. Pregnancy should be excluded before patients start treatment with Oriahnn, or the medication should be initiated within seven days of onset of menses. Following a baseline determination of BMD, periodic monitoring should occur.
Bottom Line
Oriahnn can decrease menstrual blood loss in premenopausal patients with uterine fibroids. Although it has been studied for only six months of use and may result in significant bone loss, it is labeled for up to two years of continuous therapy. Oriahnn is an option for patients who do not benefit from oral contraceptives or nonsteroidal anti-inflammatory drugs, or who need temporary relief preoperatively or are approaching menopause.3
