Do your own research. Don’t let other people dictate what treatment you should or shouldn’t take. Talk to your gynecologist about ORILISSA. See if it works for you.”
Gillian L.
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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PROVEN RESULTS IN
CLINICAL TRIALS
ORILISSA was proven to reduce 3 common types of endometriosis pain*:
1
Painful periods
2
Pelvic pain in between periods
3
Pain with sex
*There are 2 different doses of ORILISSA: 150 mg (taken once a day) or 200 mg (taken twice a day). Only the 200 mg dose was proven to work for pain with sex.
It was studied in the largest endometriosis clinical trial program to date
The program, made up of two 6-month clinical studies, showed that ORILISSA reduces endometriosis pain. It studied the two doses of ORILISSA (150 mg and 200 mg) against
placebo in:
1686 WOMEN
AGES 18-49
WITH MODERATE TO
SEVERE ENDO PAIN
We began measuring women’s pain relief right from the very start
The results below specifically show the measurements we took at 3 months. Both of the studies in the program had similar results. So to get right into it, here are the results from study #1:
Percent of women who reported reduced period pain at 3 months:
These women achieved a reduction in their pain without increasing their use of painkillers.†
†Painkillers taken by women in the clinical studies included opioids (hydrocodone with acetaminophen) or naproxen.
Percent of women who reported reduced pelvic pain in between periods at 3 months:
These women achieved a reduction in their pain without increasing their use of painkillers.§
§Painkillers taken by women in the clinical studies included opioids (hydrocodone with acetaminophen) or naproxen.
¶Only the 200 mg dose was proven to work for pain with sex.
When can I expect to feel relief for my endometriosis pain?
ORILISSA starts working in the body to lower estrogen after about 24 hours. However, pain relief will take longer. In the clinical studies, ORILISSA was proven to provide pain relief at 3 months.
Is ORILISSA a painkiller?
What is placebo and why do you keep mentioning it?
What were the results of the clinical trial program?
Experiencing endometriosis pain?
Answer a few questions about your pain to help you talk to your gynecologist about it.
Rate your pain
Stay informed
The more you know, the more you can advocate for yourself. Sign up to get more info on ORILISSA and endometriosis.
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Hear about women's personal experiences with ORILISSA
Because of her endometriosis, Joanna struggled with pain during sex. Learn about her journey to ORILISSA and less pain.
Watch Joanna's storyUSE
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.