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Annovera Generic Name & Formulations
Legal Class
Rx
General Description
Segesterone acetate 103mg, ethinyl estradiol 17.4mg; vaginal ring system.
Pharmacological Class
Progestin + estrogen.
How Supplied
Pouch—1
Manufacturer
Generic Availability
NO
Annovera Indications
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
Adult
See full labeling. Insert vaginally as directed for 21 days (3 weeks), then remove for 1 week. Repeat cycle for up to 13 cycles.
Children
Premenarchal: not recommended.
Annovera Contraindications
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
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
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
