The Most Common Symptom of Uterine Fibroids? Heavy Menstrual Bleeding. Learn More About An Oral Treatment Option.

(BPT) - Most women learn how to manage their periods beginning in their teenage years, often juggling work and school with an extra tampon or two on hand. However, for many women, managing a period often becomes a major burden due to symptoms stemming from uterine fibroids as they get into their 20s and 30s.^1,2 Uterine fibroids, also known as leiomyomas, are the most common type of non-cancerous pelvic tumors in women affecting up to 80 percent of African American women and 70 percent of Caucasian women that can develop before the age of 50.^3-6

For some, uterine fibroids can be completely asymptomatic, but approximately six million women in the U.S. are estimated to be suffering from symptoms due to uterine fibroids.^1,7,8,9 The most common uterine fibroid symptom is excessive menstrual bleeding.^4,5 Women who experience heavy menstrual bleeding commonly have to change their pads or tampons frequently and may experience blood loss that is two to three times greater, or more, than what is considered normal.^3,10,11 Heavy bleeding is also the main reason women seek treatment, with 65 percent of patients with fibroids symptoms reporting they worry about bleeding accidents through their clothes or bedding.¹²

Each woman's experience is unique, but the symptoms can interfere with her daily activities, relationships with family, friends and loved ones, and the ability to work.¹² 'I lived in constant fear of leakage,' said Julie B., a woman living with uterine fibroids. 'I carried a towel with me and tried to plan trips around my heavy periods. I purchased several pairs of black pants, just in case.'

Traditionally, uterine fibroids are commonly managed through surgery and are one of the leading causes for hysterectomies in the U.S.^3,6,13 However, women with heavy menstrual bleeding due to uterine fibroids now have a non-surgical option to consider. Earlier this year, the U.S. Food and Drug Administration (FDA) approved Oriahnn™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules). Oriahnn is the first and only FDA-approved oral medication specifically designed to treat heavy menstrual bleeding due to uterine fibroids.

Oriahnn was studied in two six-month clinical trials, including premenopausal women with heavy periods due to uterine fibroids aged 25-53. In clinical trials, Oriahnn was clinically proven to reduce heavy menstrual bleeding in women with uterine fibroids in the first month of use by at least 50 percent (six percent in placebo). By the third month of therapy, Oriahnn was able to reduce heavy bleeding due to uterine fibroids by more than 85 percent (10 percent in placebo). Ultimately, Oriahnn was proven to lighten heavy periods in about seven in ten women, compared to about one in ten women that took placebo. This finding was based on the number of women that saw both a bleeding volume reduction of 50 percent or more from the start of the clinical trial, and had an amount of 80 mL (about a third of one cup) or less by the final month of treatment. The most common adverse reactions (>5%) in clinical trials were hot flushes, headache, fatigue, and metrorrhagia.^14,15

Please click to see the full prescribing information including medication guide.

For women exploring treatment who don't want to undergo surgery, Oriahnn may be an option. 'My doctor had recommended a hysterectomy because my periods were horrific, but that's just not in my plans right now,' Julie B. said. 'I'm glad there is a non-surgical option available.'

Women who have heavy menstrual bleeding associated with uterine fibroids and want to learn more about a non-surgical treatment option, can visit Oriahnn.com and talk to an OB/GYN to see if Oriahnn may be right for them.

USE

ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is a prescription medicine used to control heavy menstrual bleeding related to uterine fibroids in women before menopause. It should not be taken for more than 24 months. It is not known if ORIAHNN is safe and effective in children under 18 years of age.

Important Safety Information

What is the most important information I should know about ORIAHNN?

ORIAHNN may cause serious side effects, including:

• Cardiovascular Conditions
  • ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age and smoke, have uncontrolled high blood pressure,high cholesterol, diabetes, or are obese. Stop taking ORIAHNN and call your healthcare provider right away or go to the nearest hospital emergency room right away if you have:
    • Leg pain or swelling that will not go away
    • Sudden shortness of breath
    • Double vision, bulging of the eyes, or sudden blindness (partial or complete)
    • Pain or pressure in your chest, arm, or jaw
    • Sudden, severe headache unlike your usual headaches
    • Weakness or numbness in an arm or leg, or trouble speaking
• Bone Loss (Decreased Bone Mineral Density [BMD])
  • While taking ORIAHNN, your estrogen levels may be low. Low estrogen levels can lead to BMD loss.
  • If you have bone loss on ORIAHNN, your BMD may improve after you stop taking ORIAHNN, but complete recovery may not occur. It is unknown if these BMD changes could increase your risk for broken bones as you age. For this reason, you should not take ORIAHNN for more than 24 months.
  • Your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density when you start taking ORIAHNN and periodically after you start.
  • Your doctor may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle.
• Effects on Pregnancy
  • Do not take ORIAHNN if you are pregnant or trying to become pregnant, as it may increase the risk of early pregnancy loss.
  • If you think you may be pregnant,stop taking ORIAHNN right away and call your HCP.
  • ORIAHNN can decrease your menstrual bleeding or result in no menstrual bleeding at all, making it hard to know if you are pregnant. Watch for other pregnancy signs like breast tenderness, weight gain, and nausea.
  • ORIAHNN does not prevent pregnancy. You will need to use effective methods of birth control while taking ORIAHNN and for 1 week after you stop taking ORIAHNN. Examples of effective methods can include condoms or spermicide, which do not contain hormones.
  • Talk to your HCP about which birth control to use during treatment with ORIAHNN. Your HCP may change the birth control you are on before you start taking ORIAHNN.

Do not take ORIAHNN if you:

• Have or have had:
  • A stroke or heart attack
  • A problem that makes your blood clot more than normal
  • Blood circulation disorder
  • Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
  • Blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
  • High blood pressure not well controlled by medicine
  • Diabetes with kidney, eye, nerve, or blood vessel damage
  • Certain kinds of headaches with numbness, weakness, or changes in vision, or have migraine headaches with aura if you are over age 35
  • Breast cancer or any cancer that is sensitive to female hormones
  • Osteoporosis
  • Unexplained vaginal bleeding that has not been diagnosed
  • Liver problems including liver disease
• Smoke and are over 35 years old
• Are taking medicines known as strong OATP1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix. Ask your HCP if you are not sure if you are taking this type of medicine.
• Have had a serious allergic reaction to elagolix, estradiol, norethindrone acetate, or any of the ingredients in ORIAHNN. Ask your HCP if you are not sure.
• FD&C Yellow No. 5 (tartrazine) is an ingredient in ORIAHNN, which may cause an allergic type reaction such as bronchial asthma in some patients who are also allergic to aspirin.

What should I discuss with my HCP before taking ORIAHNN?

Tell your HCP about all your medical conditions, including if you:

• Have or have had:
  • Broken bones or other conditions that may cause bone problems
  • Depression, mood swings, or suicidal thoughts or behavior
  • Yellowing of the skin or eyes (jaundice) or jaundice caused by pregnancy (cholestasis of pregnancy)
• Are scheduled for surgery. ORIAHNN may increase your risk of blood clots after surgery. Your doctor may advise you to stop taking ORIAHNN before you have surgery. If this happens, talk to your HCP about when to restart ORIAHNN after surgery.
• Are pregnant or think you may be pregnant.
• Are breastfeeding. It is not known if ORIAHNN can pass into your breastmilk. Talk to your HCP about the best way to feed your baby if you take ORIAHNN.

Tell your HCP about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Women on thyroid or cortisol replacement therapy may need increased doses of the hormone.

Keep a list of your medicines with you to show to your HCP and pharmacist when you get a new medicine.

What should I avoid while taking ORIAHNN?

• Avoid grapefruit and grapefruit juice during treatment with ORIAHNN since they may affect the level of ORIAHNN in your blood, which may increase side effects.

What are the possible side effects of ORIAHNN?

ORIAHNN can cause additional serious side effects, including:

• Suicidal thoughts, suicidal behavior, and worsening of mood. ORIAHNN may cause suicidal thoughts or actions. Call your HCP or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, or other unusual changes in behavior or mood. Pay attention to any changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings.
• Abnormal liver tests. Call your HCP right away if you have any of these signs and symptoms of liver problems: jaundice, dark amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, or bruising easily.
• High blood pressure.You should see your HCP to check your blood pressure regularly.
• Gallbladder problems(cholestasis), especially if you had cholestasis of pregnancy.
• Increases in blood sugar, cholesterol, and fat (triglyceride) levels.
• Hair loss (alopecia).Hair loss and hair thinning can happen while taking ORIAHNN, and it can continue even after you stop taking ORIAHNN. It is not known if this hair loss or hair thinning is reversible. Talk to your HCP if this is a concern for you.
• Changes in laboratory tests,including thyroid and other hormone, cholesterol, and blood clotting tests.

The most common side effects of ORIAHNN include: hot flashes, headache, fatigue, and irregular periods.

These are not all of the possible side effects of ORIAHNN. Tell your HCP if you have any side effect that bothers you or that does not go away. Call your HCP for medical advice about side effects.

Take ORIAHNN exactly as your HCP tells you. The recommended oral dosage of ORIAHNN is one yellow/white capsule in the morning and one blue/white capsule in the evening, with or without food.

This is the most important information to know about ORIAHNN. For more information, talk to your doctor or HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click to see the full prescribing information including medication guide.

References

1. Fuldeore MJ, Soliman AM. Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis. Int J Womens Health. 2017;9:403-411.
2. Zimmermann A, Bernuit D, Gerlinger C, Schaefers M, Geppert K. Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Womens Health. 2012;12:6. doi: 10.1186/1472-6874-12-6.
3. U.S. Department of Health and Human Services: WomensHealth.gov. Uterine Fibroids. https://www.womenshealth.gov/a-z-topics/uterine-fibroids. Accessed July 21, 2020.
4. Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2013;188:100-107.
5. Wallach EE, Vlahos NF. Uterine myomas: an overview of development, clinical features, and management. Obstet Gynecol. 2004;104:393-406.
6. De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017;95(2):100-107.
7. United States Census Bureau website. American Community Survey (ACS) 2017 1-Year Estimates Subject Tables.
8. ACOG. Uterine Fibroids. https://www.acog.org/womens-health/faqs/uterine-fibroids. Accessed September 2020.
9. Donnez J, Dolmans MM. Uterine fibroid management: from the present to the future. Hum Reprod Update. 2016;22(6):665-686.
10. Bulun S. Physiology and pathology of the female reproductive axis. Williams Textbook. Chapter 17;590-663.
11. Apgar BS, Kaufman AH, George-Nwogu U, Kittendorf A. Treatment of menorrhagia. Am Fam Physician. 2007 Jun 15;75(12):1813-9.
12. Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. Am J Obstet Gynecol. 2013;209(4): 319.e1-319.e20.
13. American College of Obstetricians and Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. 2008 Aug;112(2 Pt 1):387-400.
14. 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.
15. ORIAHNN™ (elagolix, estradiol and norethindrone acetate capsules co-formulated) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

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