STEPS

New Drug Reviews

Elagolix, Estradiol, and Norethindrone Kit (Oriahnn) for the Management of Heavy Menstrual Bleeding Associated with Fibroids

 

Am Fam Physician. 2021 Apr 15;103(8):505-506.

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).

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DrugDosageDose formCost*

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


*—Estimated lowest GoodRx price for one month of treatment based on information obtained at https://goodrx.com (accessed February 23, 2021; zip code: 66211).

DrugDosageDose formCost*

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


*—Estimated lowest GoodRx price for one month of treatment based on information obtained at https://goodrx.com (accessed February 23, 2021; zip code: 66211).

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,

Address correspondence to Jumana Antoun, MD, MS, at ja46@aub.edu.lb. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

1. DailyMed. Drug label information. Oriahnn–elagolix and estradiol and norethisterone kit. Accessed October 26, 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99f6eee7-7e52-6999-7eb8-488d06dd1710

2. Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382(4):328–340.

3. De La Cruz MSD, Buchanan EM. Uterine fibroids: diagnosis and treatment. Am Fam Physician. 2017;95(2):100–107. Accessed March 4, 2021. https://www.aafp.org/afp/2017/0115/p100.html

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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