Safety Information Update
There has been a change to the Prescribing Information. Click here to see the changes and talk with your doctor for more information.
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HOW ORILISSA WORKS
To understand how ORILISSA works, let’s start at the beginning
What is endometriosis?
Endometriosis occurs when tissue that normally lines the inside of the uterus grows outside of the uterus (where it doesn't belong). It forms growths that are called lesions.
Estrogen fuels endometriosis pain
Estrogen is a hormone that's naturally produced by your body. During your menstrual cycle, estrogen levels rise and can cause endometriosis lesions to grow. Then, during your period, the lesions can break down and shed, causing pain throughout the month.
One way to manage common symptoms of endometriosis is to reduce the amount of estrogen your body produces.
How does ORILISSA work?
ORILISSA is different—it works in its own way. That's because it's a pill that dials down estrogen. Lower estrogen levels can help manage endometriosis pain.
There are 2 doses of ORILISSA. Each dose lowers estrogen to a different level. Both the pain relief and any side effects you may experience could be different, depending on the dose you take and how your body responds. Your doctor will recommend the lowest effective dose based on your symptoms and treatment goals.
Make an appointment with your gynecologist today to see if ORILISSA could be right for you.
My gynecologist explained that my endometriosis pain is triggered by something that my body naturally makes called estrogen. And, as long as my body keeps making estrogen, I'd be in pain. That's why she had recommended ORILISSA, because it's a pill that dials down estrogen to different levels depending on the dose you take."
Kellyn P.
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Hear about women's personal experiences with ORILISSA
Emily did not think ORILISSA would help relieve her endo pain. See how she changed her mind.
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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 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. 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 healthcare provider (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 HCP 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 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 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.
US-ORIL-200129
Please click here for Full Prescribing Information and Medication Guide.