WHAT IS
ENDOMETRIOSIS

I just didn’t believe there were treatment options for my endometriosis pain. A lot of people just think it’s normal to have pain like that.

Emily

The cause of endometriosis and related pain

Endometriosis is a chronic and painful disease that occurs when endometrium (tissue that originates from the lining of your uterus) starts growing outside of your uterus, where it doesn’t belong.

The endometrial tissue that grows outside of your uterus is called a lesion or an implant. These lesions are fueled by a sex hormone called estrogen. When estrogen levels rise, these lesions (patches of endometrial tissue) can grow. Later in the menstrual cycle, they may break down and shed. This can cause pain throughout the month.

About endometrial lesions

The location of lesions can affect symptoms, but the extent of the disease doesn't necessarily relate directly to
the level of pain experienced.

Endometriosis lesions are most commonly found in the pelvic area on organs like:

  • Ovaries
  • Fallopian tubes
  • Bladder
  • Bowels
  • Intestines
  • Rectovaginal septum (structure separating vagina and the rectum)
  • Perineum
Endometriosis lesions are most commonly found on organs in the pelvic area.

Common symptoms of endometriosis

Endometriosis is not a “one size fits all” chronic condition and is more than just a “bad period.” In fact, there are many different symptoms of endometriosis. Some women with endometriosis may experience a range of symptoms, while others may experience none at all. Every woman’s symptoms are different.

There are many symptoms of endometriosis, but the most common symptoms are:

  • Painful periods: your gynecologist may call this dysmenorrhea (DIS-men-uh-REE-uh)
  • Pelvic pain in between periods: your gynecologist may call this non-menstrual pelvic pain
  • Pain with sex: your gynecologist may call this dyspareunia (DIS-puh-ROO-nee-uh)

Want to have a more productive conversation with your OB/GYN?

What endometriosis pain treatments exist

To treat your endo pain, your OB/GYN may recommend one or more of the following treatment options:

  • Over-the-counter strength painkillers (eg, ibuprofen, acetaminophen, naproxen)
  • Prescription strength NSAID painkillers (eg, ibuprofen, naproxen)
  • Prescription hormonal birth control (eg, pills, injection, implant, IUD)
  • Prescription GnRH antagonist pill
  • Prescription GnRH agonist injection or nasal spray
  • Prescription androgenic hormones (eg, danazol)

In certain circumstances, your OB/GYN may prescribe opioids (such as hydrocodone with acetaminophen). Another endometriosis treatment option is surgery, such as laparoscopy. There are several different procedures that can treat endo pain. Together, you and your gynecologist will decide which is right for you and your lifestyle.

Want to learn about a treatment option with proven results?

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What causes endometriosis?

Though the exact cause of endometriosis is unknown, most scientists think it relates to a process called retrograde menstruation. That’s when tissue that lines the inside of your uterus flows out in the wrong direction—through your fallopian tubes—during your period. The out-of-place tissue can cause pain and inflammation as it starts growing on surfaces and organs in your pelvic region.

There are other possible theories as to what can cause endometriosis, such as:

  • The immune system not destroying endometrium cells outside of the uterus the way it should
  • Metaplasia—where normal cells in the pelvic area change into endometrial cells
  • Endometrial cells forming outside of the uterus before birth; during puberty, these cells form endometrial lesions

Some lesions can even form their own nerves or scar tissue (called adhesions) between organs, which can cause pain. Although rare, lesions are sometimes found in areas further away from the pelvic area.

What are the levels of endometriosis?

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.

IMPORTANT SAFETY INFORMATION

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

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

  • Bone Loss (decreased Bone Mineral Density [BMD])
    While you are taking ORILISSA, your estrogen levels will be low. This can lead to BMD loss. If you have bone loss on ORILISSA, 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. For this reason, your healthcare provider (HCP) may limit the length of time you take ORILISSA. 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 28 days 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 pregnant, have osteoporosis, have severe liver disease, are taking medicines called organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix, the active ingredient in ORILISSA (ask your HCP if you are not sure if you are taking one of these medicines), or have had a serious allergic reaction to ORILISSA or any of the ingredients in ORILISSA. See the end of the Medication Guide for a complete list of ingredients in ORILISSA. Ask your HCP if you are not sure.

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 or other conditions 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 that contains hormones. Your HCP may advise you to change 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 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. 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 and 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 HCP.

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 doctor 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.


US-ORIL-210096

Please click here for Full Prescribing Information and Medication Guide.

 

IMPORTANT SAFETY INFORMATION

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

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is...

IMPORTANT SAFETY INFORMATION

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

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

IMPORTANT SAFETY INFORMATION

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

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is...

IMPORTANT SAFETY INFORMATION

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

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

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.

IMPORTANT SAFETY INFORMATION

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

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

  • Bone Loss (decreased Bone Mineral Density [BMD])
    While you are taking ORILISSA, your estrogen levels will be low. This can lead to BMD loss. If you have bone loss on ORILISSA, 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. For this reason, your healthcare provider (HCP) may limit the length of time you take ORILISSA. 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 28 days 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 pregnant, have osteoporosis, have severe liver disease, are taking medicines called organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix, the active ingredient in ORILISSA (ask your HCP if you are not sure if you are taking one of these medicines), or have had a serious allergic reaction to ORILISSA or any of the ingredients in ORILISSA. See the end of the Medication Guide for a complete list of ingredients in ORILISSA. Ask your HCP if you are not sure.

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 or other conditions 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 that contains hormones. Your HCP may advise you to change 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 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. 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 and 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 HCP.

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 doctor 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.


US-ORIL-210096