Real Talk About Periods, Uterine Fibroids And What You Should Know
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We all have our periods, so why is it so difficult to talk about them? It’s time to break the taboo and open up about this shared experience. Connecting with each other is how we learn to deal with that time of the month. Afterall, knowledge is power, right? And when we hear other’s stories, we realize we don’t always have to be alone on the journey.

While this subject may come up naturally with your friends at some point, you can and should feel empowered to kick off the conversation. The more you discuss with your friends and share your own experiences, the more talking about menstruation and related conditions, like uterine fibroids, become mainstream, which they should be—this is our health we are talking about.

And if you are feeling like maybe your flow is really heavy, this is a great time to compare notes with your girls, especially if it is getting in the way of your daily activities. You can also check in about the length of their periods as well. If you or your friends have a period that lasts longer than seven days, need to wear more than one pad at a time to try to control your flow or bleed in between periods, your heavy menstrual bleeding may be due to uterine fibroids. [i][ii]

Uterine fibroids, also called leiomyomas, are noncancerous tumors of the uterus that vary in size, shape and location.[iii],[iv] Having uterine fibroids can be more common than you might think. Studies show 80% of African American women and 70% of Caucasian women will develop fibroids by the age of 50.[v][vi] So why aren’t we talking about it more?

You should definitely bring up if you have a heavy flow at your next doctor’s appointment. If your doctor diagnoses you with uterine fibroids, make sure you ask about treatment options and planning. Traditionally, uterine fibroids have been primarily managed by surgery and are the leading reason for the hysterectomies performed in the U.S., but there are other treatment options available today. [iii][v][vi]

One alternative is ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) the first FDA-approved non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.[vii] In clinical trials, ORIAHNN reduced heavy menstrual bleeding due to uterine fibroids by at least 50 percent after the first month and was proven to lighten heavy periods in about 7 out of 10 women after six months, compared to about 1 and 10 women taking placebo.[vii]

ORIAHNN 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. 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, and/or are obese. Stop taking ORIAHNN and talk to a doctor right away if you have symptoms of a heart attack, stroke, or blood clot.

If you or someone you know is experiencing heavy periods due to uterine fibroids, you can create a buddy system for support and go to a medical appointment together. The more open we are, the more we stop making excuses to cancel plans for fear of bleeding through our clothes and find solutions together.

Go ahead, get together with your trusted circle and share something you thought was unexpected about your last cycle. Ask if your friends have ever experienced the same thing—you might be surprised at how quickly you can bond over these stories and more importantly, identify any issues, such as heavy menstrual bleeding, you should be discussing with your doctor. For some of us, it may still be difficult to know if you have heavy menstrual bleeding since it is so easy to think of your own period as normal, even when it isn’t. In addition to having open and honest discussions with your friends, it may also be helpful to take a quick online quiz to help assess your own situation.

Heavy menstrual bleeding doesn’t have to get in the way of our daily activities, relationships with family and friends, and work. [viii] With your girls’ support behind you, you can partner with a healthcare professional to find a potential treatment option for heavy menstrual bleeding due to uterine fibroids that best suits your personal lifestyle and treatment goals. To learn more about ORIAHNN and how to talk to your gynecologist about your period concerns, visit ORIAHNN.com.

Please see below for Use and Important Safety Information.

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

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 thinningcan happenwhile 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.

[i] ACOG. Heavy Menstrual Bleeding. https://www.acog.org/womens-health/faqs/heavy-menstrual-bleeding. Accessed April 2019.

[ii] Centers for Disease Control and Prevention. Heavy Menstrual Bleeding. https://www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html. Accessed March 2019.

[iii] 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.

[iv] ACOG. Uterine Fibroids. https://www.acog.org/Patients/FAQs/Uterine-Fibroids?IsMobileSet=false. Accessed March 2019.

[v] De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017 Jan 15;95(2):100-107.

[vi] Baird, D. D., Dunson, D. B., Hill, M. C., Cousins, D. & Schectman, J. M. High cumulative incidence of uterine leiomyoma in black and white women: Ultrasound evidence. Am. J. Obstet. Gynecol. 2013

[vii] ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules). Prescribing Information. 2020.

[viii] 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


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