Endometriosis Pain And Treatment: It's Not "One-Size Fits All"

Since she started her period at the age of 11, Sarah J. experienced moderate to severe pain associated with her menstrual cycle. "For the longest time, I thought the pain I was going through was all in my head."

Sarah is one of the estimated 4.1 million women aged 18-49 years in the U.S. diagnosed with endometriosis¹*, an estrogen-dependent disease that occurs when tissue similar to the lining of the uterus starts growing outside of the uterus, where it doesn't belong.²

Understanding Endometriosis Symptoms

The pain Sarah experienced with her period is not uncommon. In fact, the three most common symptoms associated with endometriosis include painful periods (dysmenorrhea), pelvic pain in between periods (non-menstrual pelvic pain) and pain with sex (dyspareunia).^³ Symptoms are different for everyone and not all women have all three.

"Years ago, I had no idea what endometriosis was and assumed other women were experiencing the same symptoms and just weren't talking about them," Sarah recalled. "After talking to more than ten doctors over the course of several years, I was finally diagnosed with endometriosis when I was 21 years old after convincing a doctor to listen to me. I was so relieved that I could put a name to my pain and start talking to my doctor about treatment options."

Individualized Treatment Options to Manage Pain

While there is currently no cure for endometriosis, treatment options are available. Both medical and surgical treatments for pain related to endometriosis can be effective, and treatment must be individualized.^⁴'⁵ Women may undergo multiple medical treatments and surgical procedures seeking relief from unresolved pain.^³

When patients initially present with endometriosis-related pain, Dr. Amelia Bailey, Reproductive Endocrinology and Infertility Specialist at Fertility Associates of Memphis, will usually recommend medication, specifically birth control. "Hormonal birth control can prevent estrogen fluctuation, which may reduce pain during menstruation," Dr. Bailey explained.

"If symptoms are not managed adequately by birth control, I will discuss other medical options or surgery depending on the extent of the disease and symptoms, and whether my patient wants to have children," says Dr. Bailey. "Surgery can relieve endometriosis pain, however, it is invasive and there is a chance the pain will come back."

Medical Management Options are Available

Sarah tried treating her symptoms with medical management options - including birth control - and surgery, but neither provided relief for her. A new OBGYN recommended she try ORILISSA^® (elagolix) - an FDA-approved, oral pill specifically developed for women with moderate to severe endometriosis pain.^⁶ Doctors have already prescribed it to over 20,000 women.** ORILISSA is available in two doses which allows physicians to choose a dosage based on a woman's individual needs.^⁶ Depending on the dose, ORILISSA may reduce the three most common types of endometriosis pain.^⁶

ORILISSA may not be for everyone. You should not take ORILISSA if you are or may be pregnant, have osteoporosis or severe liver disease, or take medicines such as cyclosporine or gemfibrozil. It is not known if ORILISSA is safe and effective in children under 18 years of age.

"I suffered with symptoms for many years and never thought I'd be able to get back to some of the activities that I haven't been able to because of endometriosis pain," Sarah explained. "Several months after starting ORILISSA, I noticed a reduction in the endometriosis pain I've been experiencing for all of my adult life. I'm so glad my doctor recommended ORILISSA."

Talk to Your Doctor

It's critical for women who have or think they might have endometriosis to talk openly with a doctor and be specific about their symptoms.

"As a doctor, my goal is to understand what symptoms my patients are experiencing and how the symptoms are affecting their daily activities to help determine the best methods to treat their endometriosis pain," said Dr. Bailey. "If you are experiencing any of the painful symptoms associated with endometriosis, talking to your doctor about your symptoms can lead to a treatment plan that is tailored to you."

Talking to your doctor about endometriosis symptoms is important, but it's not always easy. However, if you don't talk about your symptoms, your doctor may assume everything is fine. ORILISSA.com has a discussion guide you can use as a tool to help you explain your endometriosis pain to your doctor, and work with them to determine whether or not ORILISSA may be right for you.

Visit ORILISSA.com to learn more.

*Number derived from an online, cross-sectional survey that used 3 panels where 48,020 women aged 18 to 49 years responded between August 6, 2012 and September 14, 2012, of whom 6.1% reported a diagnosis of endometriosis. The authors used sampling weights from U.S. population statistics to estimate that 4.1 million have diagnosed endometriosis in the U.S.^¹

**The data reflects the number of women prescribed since ORILISSA was FDA approved. Data was sourced as of June 2019.

Information about ORILISSA (elagolix)

ORILISSA is the first FDA-approved pill specifically developed for women with moderate to severe endometriosis pain in over a decade. It is a prescription medicine available in two dosage amounts (150 mg once daily or 200 mg twice daily). Depending on the dose, ORILISSA may reduce three common types of endometriosis pain. These are painful periods, pelvic pain in between periods and pain with sex.***

***only ORILISSA 200 mg twice daily dose was proven to work for pain with sex.

SAFETY CONSIDERATIONS

Do not use ORILISSA if you are or may be pregnant, have osteoporosis or severe liver disease, or take medicines such as cyclosporine or gemfibrozil. ORILISSA does not prevent pregnancy. It may alter your period, so watch for other signs of pregnancy. Stop taking ORILISSA if you become pregnant. Ask about proper birth control, as some may affect how ORILISSA works. ORILISSA can cause serious side effects, including bone loss, abnormal liver tests, suicidal thoughts or behaviors, and worsening mood. Talk to your healthcare provider right away if you notice changes such as jaundice, dark amber-colored urine, suicidal thoughts or actions, depression, or worsening mood.

For more information, visit ORILISSA.com.

Please see below for Important Safety Information.

Please visit www.rxabbvie.com/pdf/orilissa_pi.pdf for the Full Prescribing Information including Medication Guide for ORILISSA.

USE

ORILISSA^® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

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

ORILISSA may cause serious side effects, including:

• Bone Loss (decreased Bone Mineral Density [BMD])

While you are taking ORILISSA, your estrogen levels will be low. This can lead to BMD loss. Your BMD may improve after stopping ORILISSA, but may not recover completely. It is unknown if these bone changes could increase your risk for broken bones as you age. Your HCP may order a DXA scan to check your BMD.

• Effects on Pregnancy

Do not take ORILISSA if you are trying to become or are pregnant, as your risk for early pregnancy loss may increase. If you think you are pregnant, stop taking ORILISSA right away and call your HCP. ORILISSA may change your menstrual periods (irregular bleeding or spotting, a decrease in menstrual bleeding, or no bleeding at all), making it hard to know if you are pregnant. Watch for other signs of pregnancy, such as breast tenderness, weight gain, and nausea. ORILISSA does not prevent pregnancy. You will need to use effective hormone-free birth control (such as condoms or spermicide) while taking ORILISSA and for one week after stopping ORILISSA. Birth control pills that contain estrogen may make ORILISSA less effective. It is unknown how well ORILISSA works while on progestin-only birth control.

Do not take ORILISSA if you:

• Are or may be pregnant, have osteoporosis, have severe liver disease, or take medicines known as strong OATP1B1 inhibitors, such as cyclosporine or gemfibrozil. If you are unsure if you are taking one of these medicines, ask your HCP.

What should I tell my HCP before taking ORILISSA?

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

• Have or have had broken bones, have other conditions, or take medicines that may cause bone problems; have or have had depression, mood problems, or suicidal thoughts or behavior; have liver problems; think you may be pregnant; or are breastfeeding or plan to be. It is unknown if ORILISSA passes into breast milk. Talk to your HCP about the best way to feed your baby if you take ORILISSA.

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

Especially tell your HCP if you take birth control pills. Your HCP may advise you to change the pills you take or your method of birth control.

What are the possible side effects of ORILISSA?

ORILISSA can cause serious side effects including:

• Suicidal thoughts, actions, or behavior, and worsening of mood. Call your healthcare provider right away, or call 911 if an emergency, if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, try to commit suicide, new or worse depression or anxiety, or other unusual changes in behavior or mood. You or your caregiver should 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: yellowing of the skin or the whites of the eyes (jaundice), dark amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, or bruising easily.

The most common side effects of ORILISSA include: hot flashes or night sweats, headache, nausea, difficulty sleeping, absence of periods, anxiety, joint pain, depression, and mood changes.

These are not all of the possible side effects of ORILISSA. This is the most important information to know about ORILISSA. For more information, talk to your doctor or healthcare provider.

Take ORILISSA exactly as your HCP tells you. 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.

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 Medication Guide for Patients, for ORILISSA at www.rxabbvie.com/pdf/orilissa_pi.pdf.

[1] Fuldeore MJ, et al. Prevalence and Symptomatic Burden of Diagnosed Endometriosis in the United States: National Estimates from a Cross-Sectional Survey of 59,411 Women. Gynecol Obstet Invest. 2017;82(5):453-461.

[2] Serdar B, et al. Role of Estrogen Receptor-β in Endometriosis. Semin Reprod Med. 2012;30(1):39-45.

[3] The American College of Obstetricians and Gynecologists (2019). Frequently Asked Questions: Endometriosis. https://www.acog.org/Patients/FAQs/Endometriosis.

[4] The Practice Committee of the American Society for Reproductive Medicine. Treatment Of Pelvic Pain Associated With Endometriosis: A Committee Opinion. Fertil Steril. 2014 Apr;101(4):927-35.

[5] Armstrong C. ACOG Updates Guideline on Diagnosis and Treatment of Endometriosis. Am Fam Physician. 2011 Jan 1;83(1):84-85.

[6] ORILISSA (elagolix) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

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