Understanding
Side Effects

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.

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. If you have bone loss on ORILISSA, 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. For this reason, your healthcare provider may limit the length of time you take ORILISSA.

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 doctor 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.

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.

ORILISSA is also 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 that are known or expected to significantly increase the blood levels of elagolix (the active ingredient in ORILISSA). Ask your healthcare provider if you are not sure if you are taking one of these medicines.
• 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 healthcare provider if you are not sure.

Weight gain was one of the less common side effects reported by women in the ORILISSA clinical trial program. Other less common side effects included decreased sex drive, diarrhea, abdominal pain, dizziness, constipation, and irritability.

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 the possible side effects of ORILISSA. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.