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Proven Results
of Orilissa
I've been taking ORILISSA...and it has given me pain relief that I honestly didn't expect.
Sara
ORILISSA is proven to relieve moderate to severe endometriosis pain
ORILISSA was studied in the largest endometriosis clinical trial program to date. It was studied in two 6-month clinical trials, including 1686 women aged 18-49 with moderate to severe endometriosis pain.
Study 1
The results below are from study #1 and show the measurements we took at 3 months for women taking the 150 mg dose once per day or the 200 mg dose twice per day vs placebo.
*Based on 248 women taking ORILISSA 150 mg, 244 women taking ORILISSA 200 mg, and 373 women taking placebo.
Study 2
The results from study #2 measured at 3 months had similar outcomes to study #1:
Percent of women who reported
reduced period pain†
150 mg=43%, 200 mg=72%, Placebo=23%
Percent of women who reported
reduced pelvic pain in between periods†
150 mg=50%, 200 mg=58%, Placebo=37%
†Based on 221 women taking ORILISSA 150 mg, 225 women taking ORILISSA 200 mg, and 353 women taking placebo.
In both studies ORILISSA was proven to reduce pain with sex in women who took the 200 mg dose.
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.
ORILISSA starts working in the body to lower estrogen within 24 hours
While ORILISSA starts working in the body within 24 hours, pain relief will take longer. In the clinical studies, ORILISSA was proven to provide pain relief at 3 months.
Consider these results when creating a discussion guide to share with your OB/GYN
Is ORILISSA a painkiller?
No, ORILISSA is not a painkiller. Painkillers work by either blocking pain messages in the brain or by reducing inflammation (depending on the type of painkiller). ORILISSA was made for endometriosis pain. It works by dialing down estrogen (which is what fuels endometriosis pain).
Also, some painkillers are taken as needed, rather than every day. ORILISSA must be taken every day, even if you’re feeling better. It’s important to take ORILISSA exactly as your doctor prescribed.
What were the results of the clinical trial program?
What is placebo and why do you keep mentioning it?
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.