HAS COVID-19 MADE PAYING FOR YOUR MEDICINE A CHALLENGE? AbbVie may be able to help. 1-800-ORILISSA (1-800-674-5477)
I read about the potential side effects and pros and cons to it. That research is what helped me determine that I was going to try ORILISSA.
Kellyn
Because ORILISSA reduces endometriosis pain by lowering estrogen, there are possible related side effects you may experience.
| Side effects | ORILISSA 150 mg once daily* | ORILISSA 200 mg twice daily† | Placebo (a pill with no active medicine)‡ |
| Hot flashes | 24% | 46% | 9% |
| Headache | 17% | 20% | 12% |
| Nausea | 11% | 16% | 13% |
| Insomnia (trouble sleeping) |
6% | 9% | 3% |
| Mood altered, mood swings (mood changes) |
6% | 5% | 3% |
| Amenorrhea (absence of periods) |
4% | 7% | < 1% |
| Depressed mood, depression, depressive symptoms, and/or tearfulness | 3% | 6% | 2% |
| Anxiety | 3% | 5% | 3% |
| Arthralgia (joint pain) |
3% | 5% | 3% |
These are not all the possible side effects of ORILISSA. The most common serious adverse events reported in the clinical studies included appendicitis (0.3%), abdominal pain (0.2%), and back pain (0.2%). For more information, ask your gynecologist or pharmacist. Always tell your gynecologist if you have any side effect that bothers you or does not go away.
*Percentage based on 475 women taking ORILISSA 150 mg in 2 studies.
†Percentage based on 477 women taking ORILISSA 200 mg in 2 studies.
‡Percentage based on 734 women taking placebo in 2 studies.
§These women were in the ORILISSA clinical trials and had all taken ORILISSA for 6 months.
5.5% taking ORILISSA 150 mg once daily and 9.6% taking ORILISSA 200 mg twice daily stopped treatment because of side effects, compared to 6% taking placebo. 0.2% of subjects treated with ORILISSA 150 mg once daily and 0.2% treated with ORILISSA 200 mg twice daily stopped treatment due to serious adverse reactions compared to 0.5% with placebo.
This is not a complete list of side effects that caused women to stop taking ORILISSA.
With ORILISSA, you may have lighter, less frequent, or irregular periods, or no periods at all. This can make it hard to know if you're pregnant. You shouldn’t take ORILISSA if you’re pregnant or trying to become pregnant, so watch for other signs of pregnancy such as breast tenderness, weight gain, and nausea.
You may not get your period while taking ORILISSA since it lowers estrogen. However, this does not mean ORILISSA will put you into early menopause. As a matter of fact, the majority of women (~60%) in clinical trials who took either dose of ORILISSA got their period within a month after they stopped taking ORILISSA. And about 95% got their period within 6 months.¶
¶These women had all taken ORILISSA for 6 months.
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.
ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:
Tell your HCP about all of your medical conditions, including if you:
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.
ORILISSA can cause serious side effects including:
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
