See ORILISSA in action

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What is ORILISSA?

ORILISSA 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.

Please see Use and Important Safety Information for ORILISSA at the end of this video.

Please see Full Prescribing Information, including Medication Guide for ORILISSA, on Orilissa.com.

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 doctor.

Please see Use and Important Safety Information for ORILISSA at the end of this video.

Please see Full Prescribing Information, including Medication Guide for ORILISSA, on Orilissa.com.

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To understand how ORILISSA works, it helps to know how endometriosis affects your body.

For women with endometriosis, tissue similar to the lining of the uterus–called endometrium–grows outside of the uterus, where it doesn’t belong, forming lesions.

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uterus

ovary

endometrium

lesion

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These lesions are fueled by a hormone called estrogen.

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estrogen

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During your menstrual cycle, when estrogen levels rise, these lesions can grow. And later, during your period, the lesions can break down and shed. This can cause pain throughout the month. One way to manage common symptoms of endometriosis is to reduce the amount of estrogen your body produces. ORILISSA works like this, leading to a reduction of estrogen. ORILISSA is an oral pill for women with moderate to severe endometriosis pain. It works in the pituitary gland,

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pituitary gland

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which is located at the base of the brain. In the pituitary gland, a hormone called GnRH activates receptors

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GnRH

Gonadotropin-Releasing Hormone

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that set off a chain reaction of signals that tell your ovaries to produce hormones such as estrogen.

ORILISSA is a GnRH receptor blocker,

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pituitary gland

GnRH

receptor blocker

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which means that it blocks GnRH from activating some of these receptors, so it leads to less estrogen being produced. How? Think of it like a game of musical chairs. The chairs represent your GnRH receptors,

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GnRH receptors

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and the women in blue represent GnRH.

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GnRH

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In order to send signals to your ovaries to produce estrogen, GnRH needs to attach to your receptors just like the women in blue try to sit in a chair. Here’s where ORILISSA steps in.

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ORILISSA logo

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When ORILISSA joins in on the game of musical chairs, it takes up some of the seats. So there are fewer seats available for GnRH. When GnRH molecules are blocked, they can’t activate receptors, and not as many signals can be sent to the ovaries telling them to produce estrogen. When less estrogen is produced, there is less fuel for the endometrial lesions. And that’s how ORILISSA works. To find out if ORILISSA is right for you, talk to your gynecologist. Share this video with the women in your life who have endometriosis.

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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?

Take ORILISSA exactly as your Healthcare Provider (HCP) tells you.

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.

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 cannot afford your medication, contact www.pparx.org for assistance.

Please click here for Full Prescribing Information and Medication Guide.

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