• Do not use ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.

• ANNOVERA does not protect against HIV infection (AIDS) and other sexually transmitted infections.

• The use of a combination hormonal contraceptive (CHC), like ANNOVERA, is associated with increased risks of several serious side effects, including blood clots, stroke, or heart attack. Do not use ANNOVERA if you have a history of these conditions, have reduced blood flow to your brain (cerebrovascular disease) or reduced blood flow or blockage in any of the arteries that supply blood to your heart (cardiovascular disease), or any condition that makes your blood more likely to clot. The risk of blood clots is highest when you first start using CHCs and when you restart the same or different CHC after not using it for 4 weeks or more.

• ANNOVERA is also not for women with high blood pressure that medicine can’t control or high blood pressure with blood vessel damage; diabetes and over 35 years old, diabetes with high blood pressure or kidney, eye, nerve, or blood vessel damage, diabetes for longer than 20 years; certain kinds of severe migraine headaches; liver disease or liver tumors; breast cancer or any cancer that is sensitive to the female hormones estrogen or progesterone; unexplained vaginal bleeding; are allergic to segesterone acetate, ethinyl estradiol or any other ingredients in ANNOVERA; or take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

• ANNOVERA can cause serious side effects, including: blood clots; toxic shock syndrome (TSS); liver problems, including liver tumors; high blood pressure; gallbladder problems; changes in the sugar and fat (cholesterol and triglycerides) levels in your blood; headache; irregular or unusual vaginal bleeding and spotting between your menstrual periods; depression; possible cancer in your cervix; swelling of your skin especially around your mouth, eyes, and in your throat (angioedema); dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Call your healthcare provider or get emergency medical care right away if any of these serious side effects occur.

• The most common side effects reported in at least 5% of women who received ANNOVERA were: headache/migraine, nausea/vomiting, vaginal yeast infection (candidiasis), lower/upper abdominal pain, painful periods, vaginal discharge, urinary tract infection, breast pain/tenderness, irregular vaginal bleeding, diarrhea, and genital itching.

USE

ANNOVERA is a ring-shaped vaginal system with hormones used by females to prevent pregnancy. ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m².

The risk information provided here is not complete. To learn more, review the ANNOVERA Patient Information and talk with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.