AdultPediatricDosage Forms & Strengths segesterone/ethinyl estradiol silicone elastomer vaginal system 103 mg/17.4 mg 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 Limitation of use The vaginal system has not been adequately studied in females with a BMI >29 kg/m² Dosage Modifications 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 Dosing Considerations With clean hands, the user can choose an insertion position that is comfortable, such as lying down, squatting, or standing; the sides of the vaginal system are pressed together for insertion into the vagina; when properly inserted, the vaginal system should be entirely in the vagina and behind the pelvic bone; the day and time of insertion should be noted so that the vaginal system can be removed 3 weeks later on the same day and at about the same timeDosage Forms & Strengths segesterone/ethinyl estradiol silicone elastomer vaginal system 103 mg/17.4 mg Contraception 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 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 Limitation of use The vaginal system has not been adequately studied in females with a BMI >29 kg/m² Dosing Considerations With clean hands, the user can choose an insertion position that is comfortable, such as lying down, squatting, or standing; the sides of the vaginal system are pressed together for insertion into the vagina; when properly inserted, the vaginal system should be entirely in the vagina and behind the pelvic bone; the day and time of insertion should be noted so that the vaginal system can be removed 3 weeks later on the same day and at about the same time Efficacy is expected to be the same for postpubertal adolescents younger than 18 years as for users 18 years and older; use of the vaginal system before menarche not indicatedInteraction CheckerEnter a drug name and segesterone/ethinyl estradiolNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (0)Serious - Use Alternative (4)belzutifanbelzutifan will decrease the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of belzutifan with hormonal contraceptives may lead to contraceptive failure or increased breakthrough bleeding. Advise females of reproductive potential to use effective nonhormonal contraception. Based on animal studies, belzutifan can cause fetal harm.elagolixsegesterone/ethinyl estradiol decreases effects of elagolix by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action of elagolix, estrogen-containing contraceptives are expected to reduce elagolix efficacy. Effects of progestin-only contraceptives on the efficacy of elagolix is unknown. Advise women to use nonhormonal contraceptives during treatment with elagolix and for 1 week after discontinuing elagolix.mavacamtenmavacamten will decrease the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Progestin and ethinyl estradiol are CYP3A4 substrates. Mavacamten may decrease systemic exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Advise patients to use a contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) or add nonhormonal contraception (eg, condoms) during coadministration and for 4 months after last mavacamten dose.omaveloxoloneomaveloxolone will decrease the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Omaveloxolone may reduce efficacy of hormonal contraceptives (eg, pill, patch, ring), implants, and progestin-only pills owing to weak CYP3A4 induction.Monitor Closely (8)carbamazepinecarbamazepine will decrease the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Advise patients to use alternative contraceptive method during coadministration; continue alternative contraception for 28 days after discontinuing therapy to ensure contraception reliability fostemsavirfostemsavir will increase the level or effect of segesterone/ethinyl estradiol by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir. Do not ethinyl estradiol dose of exceed 30 mcg/day.istradefyllineistradefylline will increase the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.lamotriginesegesterone/ethinyl estradiol will decrease the level or effect of lamotrigine by increasing hepatic clearance. Use Caution/Monitor. Combination oral contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation.levoketoconazolelevoketoconazole will increase the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors such as ketoconazole may increase plasma hormone levels.lonapegsomatropinsegesterone/ethinyl estradiol will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.mifepristonemifepristone decreases effects of segesterone/ethinyl estradiol by pharmacodynamic antagonism. Use Caution/Monitor. Backup contraceptive method recommended.warfarinsegesterone/ethinyl estradiol increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.Minor (1)ruxolitinib topicalsegesterone/ethinyl estradiol will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.belzutifanSerious - Use Alternative (1)belzutifan will decrease the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of belzutifan with hormonal contraceptives may lead to contraceptive failure or increased breakthrough bleeding. Advise females of reproductive potential to use effective nonhormonal contraception. Based on animal studies, belzutifan can cause fetal harm.carbamazepineMonitor Closely (1)carbamazepine will decrease the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Advise patients to use alternative contraceptive method during coadministration; continue alternative contraception for 28 days after discontinuing therapy to ensure contraception reliability elagolixSerious - Use Alternative (1)segesterone/ethinyl estradiol decreases effects of elagolix by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action of elagolix, estrogen-containing contraceptives are expected to reduce elagolix efficacy. Effects of progestin-only contraceptives on the efficacy of elagolix is unknown. Advise women to use nonhormonal contraceptives during treatment with elagolix and for 1 week after discontinuing elagolix.fostemsavirMonitor Closely (1)fostemsavir will increase the level or effect of segesterone/ethinyl estradiol by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir. Do not ethinyl estradiol dose of exceed 30 mcg/day.istradefyllineMonitor Closely (1)istradefylline will increase the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.lamotrigineMonitor Closely (1)segesterone/ethinyl estradiol will decrease the level or effect of lamotrigine by increasing hepatic clearance. Use Caution/Monitor. Combination oral contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation.levoketoconazoleMonitor Closely (1)levoketoconazole will increase the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors such as ketoconazole may increase plasma hormone levels.lonapegsomatropinMonitor Closely (1)segesterone/ethinyl estradiol will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.mavacamtenSerious - Use Alternative (1)mavacamten will decrease the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Progestin and ethinyl estradiol are CYP3A4 substrates. Mavacamten may decrease systemic exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Advise patients to use a contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) or add nonhormonal contraception (eg, condoms) during coadministration and for 4 months after last mavacamten dose.mifepristoneMonitor Closely (1)mifepristone decreases effects of segesterone/ethinyl estradiol by pharmacodynamic antagonism. Use Caution/Monitor. Backup contraceptive method recommended.omaveloxoloneSerious - Use Alternative (1)omaveloxolone will decrease the level or effect of segesterone/ethinyl estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Omaveloxolone may reduce efficacy of hormonal contraceptives (eg, pill, patch, ring), implants, and progestin-only pills owing to weak CYP3A4 induction.ruxolitinib topicalMinor (1)segesterone/ethinyl estradiol will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.warfarinMonitor Closely (1)segesterone/ethinyl estradiol increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor. >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%) Black Box Warnings Cigarette smoking increases the risk of serious cardiovascular events from CHC use; risk increases with age, particularly in females >35 years, and with number of cigarettes smoked; CHCs should not be used by females who are older than 35 years of age and smokeContraindications 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 Cautions 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