Segesterone/​Ethinyl Estradiol

DEA Class; Rx

Common Brand Names; Annovera

Indicated for use by females of reproductive potential to prevent pregnancy

Consider the possibility of ovulation and conception prior to the first use of the vaginal system

A high risk of arterial or venous thrombotic diseases, including females who are known to smoke, if >35 years, current or history of deep vein thrombosis or pulmonary embolism, cerebrovascular disease, coronary artery disease, thrombogenic valvular or thrombogenic rhythm diseases of the heart, inherited or acquired hypercoagulopathies, uncontrolled hypertension or hypertension with vascular disease, diabetes mellitus and are >35 years, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years’ duration, have headaches with focal neurological symptoms, or are >35 years with any migraine headaches

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 drug or excipients

Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir

>10% Headache, including migraine (38.6%)

Nausea/vomiting (25.0%)

Vulvovaginal mycotic infection/vaginal candidiasis (14.5%)

Abdominal pain/lower/upper (13.3%)

Dysmenorrhea (12.5%)

Vaginal Discharge (11.8%)

Metrorrhagia/menorrhagia (1.7%)

Headache, including migraine (1.3%)

Vaginal discharge/vulvovaginal mycotic infections (1.3%)

Nausea/vomiting (1.2%)

Acute liver test abnormalities may necessitate discontinuation of use until liver tests return to normal and causation from the vaginal system has been excluded

Discontinue the vaginal system prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; the vaginal system can be restarted approximately 2 weeks following completion of treatment with the hepatitis C combination drug regimen

For all females, including those with well-controlled hypertension, monitor blood pressure at routine visits and stop the vaginal system if blood pressure rises significantly; increase in blood pressure is more likely in older females and with extended duration of use; effect of CHCs on blood pressure may vary according to progestin in the CHC

Consider the presence of underlying risk factors that may increase risk of cardiovascular disease or venous thromboembolism (VTE), particularly before initiating the vaginal system for women >35 years, including hypertension, diabetes, dyslipidemia, or obesity

Studies suggest a small increased relative risk of developing gallbladder disease among CHC users; use of CHCs may also worsen existing gallbladder disease; a past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use; females with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis

Carefully monitor prediabetic and diabetic females who are using the vaginal system

Consider alternative contraception for females with uncontrolled dyslipidemia; the vaginal system may cause adverse lipid changes; females with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using the vaginal system

If a female using the vaginal system develops new headaches that are recurrent, persistent, or severe, evaluate cause and discontinue use if indicated; consider discontinuation in the case of increased frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event)

Carefully observe females with a history of depression and discontinue use if depression recurs to a serious degree; data on depression are limited

Some studies suggest that CHCs are associated with increase in risk of cervical cancer or intraepithelial neoplasia; however, the extent to which these findings are due to differences in sexual behavior and other factors is controversial

Estrogen component of the vaginal system may raise serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin; dose of replacement thyroid hormone or cortisol therapy may need to be increased

Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy; discontinue the vaginal system if pregnancy occurs; there is no reason to use CHCs during pregnancy

Contraceptive hormones and/or metabolites are present in human milk; CHCs can reduce milk production in breastfeeding females; reduction can occur at any time but is less likely to occur once breastfeeding is well established; advise a nursing female to use another method of contraception until she discontinues breastfeeding