Contraception:
Indications for: ANNOVERA
Prevention of pregnancy for up to 1 year (13 cycles).
Limitations of Use:
Not adequately studied in females with BMI >29kg/m2.
Adult Dosage:
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 Dosage:
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.
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 Classification:
Progestin + estrogen.
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.
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.
Generic Drug Availability:
NO
How Supplied:
Pouch—1
