This article is sponsored by AbbVie
Uterine fibroids affect more than 80 percent of Black patients by the age of 50, compared to almost 70 percent of Caucasian patients, according to The National Center for Biotechnology Information (NCBI). 1
For Black patients, fibroids tend to be more severe in their reproductive years and cause more intense symptoms, NCBI notes. 1
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While most fibroids are non-cancerous, they do have symptoms that can be hard to manage such as heavy menstrual bleeding. Because some patients can be asymptomatic or due to individual coping mechanisms, there may be a delayed diagnosis of about 3.6 years, NCBI adds. 1
Why the delay?
Veronica Gillispie-Bell, MD, MS, who is a paid sponsor of AbbVie, is a practicing OB-GYN and section head of women’s services at Ochsner Kenner in New Orleans. She has dedicated nearly 20 years to researching uterine fibroids. In her experience, she believes systemic racism and health disparities play a major part in Black patients not being heard. She also believes a lack of dialogue plays a major part. “Our society has normalized heavy menstrual bleeding and that as long as we can still function and move, we’re okay,” she says.
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For most patients, talking about periods is taboo and can be embarrassing or uncomfortable, but it’s those conversations that will raise more awareness about fibroids and help patients receive an earlier diagnosis. “Because we don’t talk about it, you only know how heavy your period is, so we have to have these conversations,” Dr. Gillispie-Bell adds.
Types of Fibroids
There are three types of fibroids: 2
- Intramural fibroids: Grow within the muscular uterine wall
- Submucosal fibroids: Found in the uterine cavity
- Subserosal fibroids: Found outside the uterus
Fibroids can grow as a single tumor, or there can be many of them in the uterus. They can be as small as an apple seed or as big as a grapefruit.2 There are no known causes for fibroids
Symptoms
The first step in determining if you may have fibroids is to look at the symptoms. One of the main symptoms of uterine fibroids is heavy menstrual bleeding.
Dr. Gillispie-Bell asks her patients specific questions to figure out how to move forward, such as how often they change their pads or tampons.
“If you need to change your tampon or pad after less than 2 hours, then that means your cycle is heavy,” she says. “Additionally, if you pass clots the size of a quarter or larger, that is heavy bleeding. If you have this type of bleeding, speak with your doctor.”
Finding the Right Doctor
Getting the proper treatment starts with you. If you are experiencing heavy menstrual bleeding due to fibroids, it’s important to see a doctor and voice your concern. If your doctor is dismissive or does not take your concerns seriously, find a doctor that will listen.
“If you are going to your provider and saying I have these different symptoms, and they’re dismissive, then that is probably not the provider for you because doctors should acknowledge whatever symptoms the patient is presenting,” Dr. Gillispie-Bell notes. “But especially if you’re saying I’m having heavy menstrual bleeding, and someone says that’s normal then that may not be the provider for you.”
Treatment Options
Dr. Gillispie-Bell reminds patients that they should mutually decide care with their doctor. She advises patients to avoid pressure to agree to recommendations with which they are not comfortable.
When Dr. Gillispie-Bell became a medical student, there were not many options for patients with fibroids. “My mom was diagnosed with fibroids and had a hysterectomy. It was the right solution for her, but at the time, I didn’t know what a fibroid was, so I started researching.”
Be sure to do your own research and make sure your doctor is giving you every possible option. “We live in a time with a plethora of media and access to information, so I encourage patients to equip themselves with information on all the options that are available, so they are able to ask the questions if your provider is not bringing up all options available for you,” she adds.
So what are the options? 3
Surgical Options
Surgical options may include myomectomy where the fibroid is surgically removed or hysterectomy where the entire uterus is surgically removed.
Oral Medication
Last year, the FDA approved ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) as an oral medication indicated to manage heavy menstrual bleeding due to uterine fibroids in premenopausal women. 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.
Please see additional Important Safety Information for Oriahnn below.
Dr. Gillispie-Bell stresses the importance of having conversations with not only your doctor, but the women around you because it will raise more awareness about fibroids. “Our periods shouldn’t be a secret. These conversations could make a huge difference in our health,” she says.
To learn more about Oriahnn and how to talk to your gynecologist, visit ORIAHNN.com.
Please click to see the Full Prescribing Information, including the 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 28 days 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 of 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 see the Full Prescribing Information, including the Medication Guide.
US-ORIA-210283
Sources
- The Health Disparities of Uterine Fibroids for African American Women: A Public Health Issue (2013, Aug 11)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874080/ - Uterine fibroids (2019, April 1)
https://www.womenshealth.gov/a-z-topics/uterine-fibroids - Choosing the best treatment for uterine fibroids (2021, May 27)
https://www.mayoclinic.org/diseases-conditions/uterine-fibroids/in-depth/choosing-the-best-treatment-for-uterine-fibroids/art-20512780?utm_source=google_search&utm_medium=cpc&utm_campaign=mc_cs_ag_131879696788utm_content=mc_cs_cid_526339569786
