Generic Name and Formulations:
Norethindrone 1mg, ethinyl estradiol 20micrograms (24 soft gelatin caps); inert+ (4 soft gelatin caps); + contains ferrous fumarate 75mg.
Indications for TAYTULLA:
1 cap daily for 28 days; repeat. Switching from other hormonal contraception: see full labeling.
Premenarchal: not recommended.
High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Undiagnosed abnormal uterine bleeding. Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic disease or tumors. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Cigarette smoking and serious cardiovascular events.
Increased risk of cardiovascular events esp. in cigarette smokers >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. Cardiovascular disease. Gallbladder disease. Pregnancy-related cholestasis. Diabetes. Prediabetes. Uncontrolled dyslipidemia. Hypertriglyceridemia. Depression. Hereditary angioedema. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. Cholasma gravidarum. Monitor blood pressure. Do regular complete physical exams. BMI >35kg/m2: not evaluated. May need non-hormonal contraception with Sunday starts or postpartum use (see full labeling). Postmenopausal women, nursing mothers: not recommended.
Progestin + estrogen.
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Taytulla prior to starting HCV regimen and restart 2wks after completion. May be antagonized by CYP3A4 or other enzyme inducers (eg, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, St. John’s wort); use backup contraception. May be potentiated by atorvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole). May be affected by HIV/HCV protease inhibitors or NNRTIs. May antagonize lamotrigine; adjust dose. May need dose adjustment of thyroid or cortisol hormones. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins, sex hormone binding globulins).
Headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, weight gain; breakthrough bleeding, amenorrhea, oligomenorrhea, cholasma, liver disease.