INDICATIONS AND USAGE
Taytulla is an estrogen/progestin combination oral contraceptive (COC) indicated for use by females of reproductive age to prevent
pregnancy. Efficacy in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
IMPORTANT SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
Taytulla is contraindicated in pregnant patients, in women with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past, and in women using Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Warnings and Precautions
Discontinue Taytulla if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Taytulla should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, treatment should be discontinued.
Taytulla should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women who are prediabetic or diabetic should be monitored while using Taytulla. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using Taytulla who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated.
In the clinical trial for Taytulla, the most common adverse reactions (incidence ≥2%) were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Please see full Prescribing Information, including Boxed Warning, for Taytulla.