UNDERSTANDING
SIDE EFFECTS

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'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.

The most common side effects of ORILISSA include: hot flashes or 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.