Eegesterone + Ethinyl estradiol vaginal prep

Eegesterone + Ethinyl estradiol vaginal prep is used for: Contraception

Contraception Indicated for use by females of reproductive potential to prevent pregnancy Consider the possibility of ovulation and conception prior to first use of the vaginal system Place one vaginal system in the vagina and it should remain in place continuously for 21 days (3 complete weeks) After 3 weeks, remove the vaginal system for 1 week for a dose-free interval, during which a withdrawal bleed usually occurs Following the dose-free interval, reapply the removed and cleaned vaginal system for another 21 continuous days (3 complete weeks); this pattern of use made up of 3 weeks in and 1 week out is a cycle of use, which provides contraception for 13 cycles Hepatic impairment No studies conducted to evaluate effect of hepatic impairment on disposition of the vaginal system; steroid hormones may be poorly metabolized in patients with hepatic impairment; acute or chronic disturbances of liver function may necessitate discontinuation of combination hormonal contraceptive (CHC) use until markers of liver function return to normal and CHC causation has been excluded

Renal impairment No studies conducted in subjects with renal impairment; not recommended in patients with renal impairment

Intravaginal Administration After placing the vaginal system for 21 days, in the vagina, it should be removed and cleaned with mild soap and warm water, patted dry with a clean cloth towel or paper towel, and placed in its case during the 1-week dose-free interval; at the end of the dose-free interval, clean the vaginal system and place back in the vagina for another 21 days (3 complete weeks) Removing the vaginal system Removing the vaginal system The vaginal system can be removed by hooking an index finger into the vaginal system inside the vagina and gently pulling 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

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

Pregnancy 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 Lactation 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

Side effects of Eegesterone + Ethinyl estradiol vaginal prep : >10% >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%) 1-10% Metrorrhagia/menorrhagia (1.7%) Headache, including migraine (1.3%) Vaginal discharge/vulvovaginal mycotic infections (1.3%) Nausea/vomiting (1.2%)

CHCs lower the risk of becoming pregnant primarily by suppressing ovulation Ethinyl estradiol (EE): Reduces LHRH release from hypothalamus, reduces gonadotropin release from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues Segesterone acetate (SA): Progestin; inhibits gonadotropin secretion from pituitary; prevents follicular maturation and ovulation, and stimulates growth of mammary tissues