Understanding side effects & safety considerations

UNDERSTANDING
SIDE EFFECTS & SAFETY
CONSIDERATIONS

Understanding possible side effects

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

Most common side effects reported by women in the clinical trials

The percentage of women who experienced these is shown in the table below.

ORILISSA
150 mg
once daily*
ORILISSA
200 mg
twice daily
Placebo
(a pill with no
active medicine)
Hot flash or night sweats 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%

*Percentage based on 475 women taking 150 mg dose in 2 studies.
Percentage based on 477 women taking 200 mg dose 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 doctor or pharmacist.

How many women taking ORILISSA in the clinical trial programs stopped taking it because of the side effects shown below?*

  • Hot flash or night sweats: Less than 2% of women stopped taking ORILISSA due to hot flashes or night sweats.
  • Headache: Less than 1% of women stopped taking ORILISSA due to headache.
  • Nausea: About 1% of women stopped taking ORILISSA due to nausea.

The majority of the women who stopped taking ORILISSA due to hot flashes or night sweats, or nausea did so within the first 2 months of treatment. Always tell your doctor if you have any side effect that bothers you or does not go away.

*This is not a complete list of side effects that caused women to stop taking ORILISSA.

 

After taking ORILISSA for 6 months in the clinical studies, 77% of women decided to keep taking it in additional studies

These additional studies further evaluated safety considerations and how well it works.

Important things to know when taking ORILISSA


ORILISSA can cause serious side effects including bone loss (decreased bone mineral density [BMD])

  • While you are taking ORILISSA, your estrogen levels will be lower. Lower estrogen levels can lead to BMD loss.
  • Your bone density may improve after you stop taking ORILISSA, but complete recovery may not occur. It is unknown if these bone changes could increase your risk for broken bones as you age.
  • If you have conditions or take other medicines that can cause bone loss, or if you have broken a bone with minimal or no injury, your doctor may order an X-ray test called a DXA scan to check your BMD.
  • Your doctor may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle that promotes bone health.
  • Tell your doctor if you have or have had broken bones and if you have other conditions or take medicine that may cause bone problems.

More information about BMD

Bone is a living tissue. And throughout the course of a person’s life, the body naturally loses old bone to make room for new bone. The following can cause women to experience bone loss:

  • Pregnancy and breastfeeding: bone loss naturally occurs because the body is providing calcium to the baby.
  • Endurance exercise (extreme biking, swimming, running, etc.): this may significantly reduce the body’s estrogen levels, which may lead to bone loss.
  • Some medical treatments for endometriosis or endometriosis pain: in order to provide pain relief, some treatments reduce the body’s estrogen levels, which may lead to bone loss.

Bone loss experienced in these instances may or may not fully recover over time.



ORILISSA may change your menstrual periods

With ORILISSA, you may have lighter, less frequent or irregular periods, or no periods at all, making it hard to know if you are pregnant. Watch for the signs of pregnancy such as breast tenderness, weight gain, and nausea. After finishing the 6-month clinical trials, the majority of women who took either dose of ORILISSA got their period within a month (~60%; and ~ 95% got it within 6-months).

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.



It’s important to use effective birth control

ORILISSA does not prevent pregnancy. You'll need to use effective methods of birth control while taking ORILISSA and for 1 week after you stop taking ORILISSA. So talk to your doctor about which birth control to use.  Your doctor may change the birth control you were on before you start taking ORILISSA.

Birth control pills that contain estrogen may make ORILISSA less effective. It is not known how well ORILISSA will work while you are taking progestin-only birth control.



Talk to your doctor if you plan on breastfeeding

The impact of ORILISSA on breast milk and the nursing baby is not known. Talk to your doctor about the best way to feed your baby if you take ORILISSA.



ORILISSA can also cause the following serious side effects:

  • ORILISSA may cause suicidal thoughts or actions. Out of 2090 women, 4 experienced suicidal thoughts, and 1 woman completed suicide who participated in the ORILISSA 150 mg dose group.
    • Call a doctor right away if you have any of these symptoms: 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 doctor if these symptoms appear or worsen while taking ORILISSA.
  • Abnormal liver tests. Call your doctor 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 (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.