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What is NEXTSTELLIS?

• NEXTSTELLIS is a birth control pill (oral contraceptive) used by females to prevent pregnancy.
• NEXTSTELLIS does not protect against HIV infection (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 BMI of 35 or higher.

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 in your arms, legs, lungs, or eyes.
• have a problem with your blood that makes it clots more than normal.
• have certain heart valve problems, or an irregular heartbeat that increases your risk of having blood clots.
• had a stroke.
• had a heart attack.
• have high blood pressure that medicine cannot be controlled by medicine or have high blood pressure with blood vessel problems.
• have diabetes: with high blood pressure or kidney, eye, nerve, or blood vessel damage or have had diabetes for more than 20 years.
• have certain kinds of severe migraine headaches with aura.
• have liver problems, including liver tumors.
• have any unexplained vaginal bleeding.
• have or have had breast cancer or any cancer that is sensitive to female hormones.
• have kidney disease or kidney failure.
• have reduced adrenal gland function (adrenal insufficiency).
• take Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of liver enzyme “alanine aminotransferase” (ALT in the blood).

If any of these conditions happen while you are taking NEXTSTELLIS, stop taking NEXTSTELLIS right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking NEXTSTELLIS.

What else should I know about 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 risk of blood clots after surgery. Talk to your healthcare provider about taking NEXTSTELLIS before and after your surgery or if you are going to 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 (jaundice) 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 breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all 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 possible side effects of NEXTSTELLIS?

• NEXTSTELLIS may cause serious side effects including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes.

Other serious side effects include:

• high potassium levels in your blood (hyperkalemia)
• high blood pressure
• new or worsening headaches including migraine headaches
• possible cancer that is sensitive to female hormones, such as breast cancer, skin cancer (melanoma), lung cancer, and brain cancer.
• liver problems
• changes in the sugar and fat (cholesterol and triglycerides) levels in your blood.
• gallbladder problems (cholestasis).
• irregular or unusual vaginal bleeding or spotting between your menstrual periods, especially during the first 4 months of taking NEXTSTELLIS, or the absence of 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 around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma).

What are the most common side effects of NEXTSTELLIS?

• irregular vaginal bleeding (including absence of period)
• mood changes
• headache
• breast tenderness, pain, and discomfort
• pain with your periods
• acne
• weight gain
• decreased sex drive