What is NEXTSTELLIS?

NEXTSTELLIS is a prescription combination oral birth control pill used for the prevention of pregnancy. NEXTSTELLIS does not protect against HIV infections (AIDS) and other sexually transmitted diseases. NEXTSTELLIS may be less effective if you have a body mass index (BMI) of 30 or higher. It is not known if NEXTSTELLIS is safe and effective in females with a body mass index (BMI) of 35 or higher. If you are moderately obese, discuss with your healthcare provider whether NEXTSTELLIS is appropriate for you.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT NEXTSTELLIS?

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NEXTSTELLIS, are contraindicated in females who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.1)]

Who should not take NEXTSTELLIS?

Do not use NEXTSTELLIS if you smoke and are 35 years of age or older. Do not use NEXTSTELLIS if you have or have had blood clots, history of heart attack, stroke or certain heart valve problems, high blood pressure that medicine cannot control, diabetes for more than 20 years, severe migraine headaches with aura, breast cancer or any cancer that is sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the vagina, have kidney disease or kidney failure, have reduced adrenal gland function, or if you take Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood.

What else should I know about taking NEXTSTELLIS?

Before taking NEXTSTELLIS, tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled for surgery. NEXTSTELLIS may increase your risks of blood clots after surgery. Talk to your healthcare provider about taking NEXTSTELLIS before and after your surgery or if you are going to be unable to walk for an extended period of time.
• are depressed now or have been depressed in the past.
• had yellowing of your skin or eyes caused by pregnancy.
• are pregnant or think you may be pregnant.
• are breastfeeding or plan to breastfeed. NEXTSTELLIS may decrease the amount of breast milk you make. NEXTSTELLIS may pass into your breastmilk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NEXTSTELLIS may affect the way other medicines work, and other medicines may affect how well NEXTSTELLIS works.

What are the most serious risks of taking NEXTSTELLIS?

NEXTSTELLIS may cause serious side effects that may lead to death including blood clots in your lungs, heart attack, or a stroke. Some other examples of serious blood clots include blood clots in the legs or eyes. Other serious risks include high potassium levels in your blood, high blood pressure, new or worsening headaches including migraine headaches, possible cancer that is sensitive to female hormones, liver problems, changes in the sugar and fat blood levels, gallbladder problems, irregular or unusual vaginal bleeding, spotting, or absence of menstrual periods, depression, possible cancer of the cervix, swelling of the skin especially around the mouth, eyes, and in the throat, and dark patches of skin around your forehead, nose, cheeks, and around your mouth, especially during pregnancy.

What are the possible side effects of NEXTSTELLIS?

The most common side effects reported by females taking NEXTSTELLIS in a study were spotting or bleeding between menstrual periods, mood changes, headache, breast tenderness, pain and discomfort, painful periods, acne, weight gain, and decreased sex drive.

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

Please see the full Prescribing Information, including Boxed Warning, and Patient Information.