WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning.
- Females over 35 years old who smoke should not use ANNOVERA.
- Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.
ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of ANNOVERA; and use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
WARNINGS AND PRECAUTIONS
- Stop ANNOVERA if a thrombotic or thromboembolic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Start ANNOVERA no earlier than 4 weeks after delivery, in females who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years.
- Discontinue if jaundice occurs.
- Stop ANNOVERA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir. ANNOVERA can be restarted 2 weeks following completion of this regimen.
- Do not prescribe ANNOVERA for females with uncontrolled hypertension or hypertension with vascular disease. Monitor blood pressure and stop use if blood pressure rises significantly in females with well-controlled hypertension.
- Monitor glucose in pre-diabetic or diabetic females taking ANNOVERA. Consider an alternate contraceptive method for females with uncontrolled dyslipidemias.
- Patients using ANNOVERA who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated. ANNOVERA should be discontinued if indicated.
- Other warnings include: gallbladder disease; depression; cervical cancer; increased serum concentrations of binding globulins; hereditary angioedema; chloasma (females who tend to develop chloasma should avoid exposure to the sun or UV radiation while using ANNOVERA); toxic shock syndrome (TSS) (if a patient exhibits symptoms of TSS, remove ANNOVERA, and initiate appropriate medical treatment); vaginal use (ANNOVERA may not be suitable for females with conditions that make the vagina more susceptible to vaginal irritation or ulceration).
The most common adverse reactions reported in at least 5% of women who received ANNOVERA were: headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, lower/upper abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast pain/tenderness/discomfort, bleeding irregularities including metrorrhagia, diarrhea, and genital pruritus.
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of ANNOVERA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with ANNOVERA.
ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is a progestin/estrogen combination hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy.
Limitations of Use: ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2.
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.