Understanding side effects & safety considerations

UNDERSTANDING
SIDE EFFECTS

Take a closer look at the safety info

Because ORILISSA treats endometriosis pain by lowering estrogen, there are possible related side effects you may experience.


Most common side effects experienced by women in the clinical trials:

The percentage of women who experienced these side effects is shown below.

  ORILISSA 150 mg once daily*   

  ORILISSA 200 mg twice daily   

   Placebo (a pill with no active medicine)   

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*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 are not all the possible side effects of ORILISSA. 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.


How many women stopped taking ORILISSA in the clinical trial program due to side effects?

In the ORILISSA clinical studies, about 10% or less stopped taking ORILISSA due to side effects.*

*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.


Some of the most common side effects for why women stopped taking it are shown below‖*:

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‖This is not a complete list of side effects that caused women to stop taking ORILISSA.
*Percentage based on 952 women taking ORILISSA in 2 studies.



Want to learn more about the ORILISSA clinical trials?


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Got questions? We've got answers.

Well, about 1 out of 4 women taking ORILISSA 150 mg and about 2 out of 4 women taking ORILISSA 200 mg experienced hot flashes or night sweats. Of these women, 94% reported that the hot flashes they had were mild or moderate (303 of 324 women).§ Less than 2% of women stopped taking ORILISSA because of hot flashes.*

§Mild/moderate were definitions used by the clinical researcher to rate the severity of each side effect. Mild was defined as temporary and easily tolerated. Moderate was defined as causing discomfort and interrupting usual activities.
*This is not the only side effect that caused women to stop taking ORILISSA.

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.

To understand BMD, first let’s chat about bone. Bone’s a living tissue. Throughout one’s life, estrogen helps the body break down old bone to replace it with new bone. When estrogen levels are lower, the body may break down old bone faster than it replaces it—causing bone loss (or decreased BMD). This can happen anytime estrogen levels are lower—while breastfeeding, throughout pregnancy, during endurance exercise, or if you're taking medications that lower estrogen.

Since ORILISSA works by lowering estrogen, it can cause BMD loss. And after stopping ORILISSA, BMD may improve, but complete recovery may not occur. It’s also not known if these bone changes could increase the risk for broken bones as you age.

So, what can you do about BMD while taking ORILISSA? Start by talking to your gynecologist. They may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle that promotes bone health. They may also order a DXA scan (a type of X-ray) to check your BMD. Lastly, don’t forget to tell your gynecologist if you have or have had broken bones and if you have other conditions or take medicine that may cause bone problems.

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 think 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.

Do not take ORILISSA if you are trying to become or are pregnant. If you think you are pregnant, stop taking ORILISSA right away and call your doctor.  If you become pregnant while taking ORILISSA, we encourage you to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your doctor or call 1-833-782-7241 to enroll in this registry.

ORILISSA does not prevent pregnancy. You’ll need to use effective methods of birth control while taking ORILISSA and for one week after you stop taking it. Birth control pills that contain estrogen may make ORILISSA less effective. It’s not known how well ORILISSA will work while you’re taking progestin-only birth control. So, talk to your doctor about which birth control to use. They may change your birth control before you start taking ORILISSA.

If you’re breastfeeding or plan on breastfeeding while taking ORILISSA, talk to your gynecologist. The impact of ORILISSA on breast milk and the nursing baby is not known, so ask your gynecologist about the best way to feed your baby while on ORILISSA.

ORILISSA is not right for you if you have certain conditions or are taking certain medications. You should not take ORILISSA if you:

  • are or may be pregnant
  • have osteoporosis
  • have severe liver disease
  • are taking medicines known as strong OATP1B1 inhibitors such as cyclosporine or gemfibrozil. Ask your doctor if you are not sure if you are taking one of these medicines

It’s a good idea to discuss your full medical history with your gynecologist before starting a medication. So, before you take ORILISSA, tell your gynecologist about all of your medical conditions, including if you:

  • have or have had broken bones
  • have other conditions or take medications 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. You should avoid becoming pregnant while taking ORILISSA
  • are breastfeeding or plan to breastfeed

And don’t forget to tell your gynecologist about all the medicines you take, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements
  • birth control

Make sure to know the medicines you take. Keep a list of your medicines with you to show to your gynecologist and pharmacist whenever you get a new medicine.

ORILISSA can cause the following serious side effects:

  • ORILISSA may cause suicidal thoughts or actions. We understand how serious this is, so we want to tell you a bit more about what happened in the clinical trials and why this warning exists. See, out of the 2090 women studied,** 4 experienced suicidal thoughts. 2 of these women stopped taking ORILISSA because of this. One woman from the clinical trials committed suicide. Investigators determined she was experiencing life stressors. We want you to know about it because you should have all the facts when deciding if a medication is right for you.
    • Your safety is important. So please call a gynecologist right away if any of these symptoms appear or worsen: thoughts of 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.
    • It's important to share any conditions you have, including depression, and talk about any mood problems or suicidal thoughts or behaviors before starting ORILISSA. Women with depression are not restricted from taking ORILISSA but it's important to call your gynecologist if these symptoms appear or worsen while taking ORILISSA. In the ORILISSA clinical trial program, 19% of women had a history of depression and 13% were taking antidepressants when they entered the study.
  • Abnormal liver tests. Call your gynecologist right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or whites of the eyes (jaundice), dark amber-colored urine, feeling tired (fatigue or exhaustion), nausea and vomiting, generalized swelling, right upper stomach area (abdomen) pain, bruising easily.

**2090 women were treated with ORILISSA in the phase 2 and phase 3 studies.
Percentages based on 324 women with a history of depression and 217 women taking antidepressants in clinical studies.