• Contraception

Annovera Generic Name & Formulations

General Description

Segesterone acetate 103mg, ethinyl estradiol 17.4mg; vaginal ring system.

Pharmacological Class

Progestin + estrogen.

How Supplied



Generic Availability


Annovera Indications


Prevention of pregnancy for up to 1 year (13 cycles).

Limitations of Use

Not adequately studied in females with BMI >29kg/m2.

Annovera Dosage and Administration


See full labeling. Insert vaginally as directed for 21 days (3 weeks), then remove for 1 week. Repeat cycle for up to 13 cycles.


Premenarchal: not recommended.

Annovera Contraindications


High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with hypertension or vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive cancer. Undiagnosed abnormal uterine bleeding. Liver tumors, acute hepatitis or severe cirrhosis. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Annovera Boxed Warnings

Boxed Warning

Cigarette smoking increases risk of serious cardiovascular events.

Annovera Warnings/Precautions


Evaluate for history of thrombotic or thromboembolic disorders prior to initiation. Increased risk of cardiovascular events (eg, stroke, MI) esp. in smokers, females (>35yrs of age). Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism, and during prolonged immobilization. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias; consider alternative therapy. Obesity. Hypertriglyceridemia. Pregnancy-related cholestasis. Depression. Evaluate if significant changes in headaches (consider discontinuation), irregular uterine bleeding, amenorrhea. Monitor BP routinely; discontinue if significant increase. Hereditary angioedema. History of chloasma gravidarum; avoid sun or UV radiation exposure. Menopause: not indicated. Renal impairment: not recommended. Start no sooner than 4 weeks postpartum if not breastfeeding. Pregnancy: discontinue if occurs. Nursing mothers: use alternate contraception until breastfeeding discontinued.

Annovera Pharmacokinetics

See Literature

Annovera Interactions


See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Annovera prior to starting HCV regimen and restart 2 weeks after completion. May be antagonized by CYP3A4 or other enzyme inducers (eg, aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, St. John’s wort); use an alternative method or a backup contraception. May be potentiated by atorvastatin, rosuvastatin, acetaminophen, ascorbic acid, itraconazole, voriconazole, fluconazole, ketoconazole, grapefruit juice, vaginal miconazole (oil-based). May be affected by HIV/HCV protease inhibitors, NNRTIs. May antagonize lamotrigine, acetaminophen, morphine, salicylic acid, temazepam. May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May need dose adjustment of thyroid hormones. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). Avoid concurrent oil-based vaginal lubricants, suppositories.

Annovera Adverse Reactions

Adverse Reactions

Headache, migraine, nausea, vomiting, vulvovaginal mycotic infection/candidiasis, abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast tenderness/pain/discomfort, metrorrhagia, menstrual disorders, diarrhea, genital pruritus; toxic shock syndrome, cholasma, serious CV events, liver disease, VTEs, psychiatric events, hypersensitivity, spontaneous abortions.

Annovera Clinical Trials

See Literature

Annovera Note

Not Applicable

Annovera Patient Counseling

See Literature