COMMENT & CONTROVERSY
NEW HORMONAL MEDICAL TREATMENT IS AN IMPORTANT ADVANCE FOR AUB CAUSED BY UTERINE FIBROIDS
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2020)
New AUB medical treatment
I appreciate Dr. Barbieri’s concise and pertinent review of myomatous disease etiology and treatments. I have a question regarding therapy with Oriahnn (elagolix, estradiol, and norethindrone acetate capsules). Most myomatous-related bleeding occurs in premenopausal women. The elagolix suppresses luteinizing hormone and follicle stimulating hormone, and the norethindrone is added to protect the endometrium from the estradiol. Do the elagolix and norethindrone also provide contraception?
Geoffrey J. Zann, MD, MBA
Boca Raton, Florida
Dr. Barbieri responds
Dr. Zann raises an important clinical question that arises often in practice. The US Food and Drug Administration (FDA) has not approved Oriahnn as a contraceptive. The FDA prescribing information recommends: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing Oriahnn. Oriahnn may delay the ability to recognize the occurrence of a pregnancy because it alters menstrual bleeding. Perform pregnancy testing if pregnancy is suspected and discontinue Oriahnn if pregnancy is confirmed.
In Oriahnn, the elagolix dose is 300 mg twice daily. If a patient reliably takes 600 mg of elagolix daily, it is highly unlikely that she will ovulate. However, in practice, many patients miss doses of their medication, reducing the contraceptive effectiveness. For example, the combined estrogen-progestin contraceptive is highly effective at suppressing ovulation, but the Centers for Disease Control and Prevention (CDC) estimates that 9% of women taking an estrogen-progestin contraceptive will become pregnant each year.1,2
Oriahnn also contains norethindrone acetate at a dose of 0.5 mg daily. The FDA has approved norethindrone at a dose of 0.35 mg daily as a contraceptive. The CDC estimates that 9% of women prescribed a progestin-only pill will become pregnant each year with typical use.1,2
I counsel my patients that if they reliably take their prescribed Oriahnn medication as directed, they are unlikely to become pregnant, and a backup method of contraception will further help to reduce their risk of becoming pregnant.
References
- Centers for Disease Control and Prevention. US selected practice recommendations for contraceptive use, 2013. MMWR Morbid Mortal Weekly Rep. 2013;62(RR-5):1-59.
- Trussell J. Contraceptive failure in the United States. Contraception. 2011;83:397-404.
