Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, today announced the availability of TAYTULLA™ (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1mg/20mcg, the first and only oral contraceptive in a softgel capsule for the prevention of pregnancy.
"As a leader in women's healthcare, we are pleased to bring to market TAYTULLA, the first and only oral contraceptive in a softgel capsule, providing women with an important new and effective option to consider with their healthcare providers," said Bill Meury, Chief Commercial Officer at Allergan. "The patented softgel technology of TAYTULLA was designed with absorption and solubility in mind, contains 20 mcg of estrogen, and offers women pregnancy prevention with short, light periods."
TAYTULLA will be commercially available in blister cards containing 24 oval, opaque, pale pink (active) soft gelatin capsules, each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol, and 4 oval, opaque, maroon (nonhormonal placebo) capsules containing iron.
For more information about TAYTULLA, visit www.TAYTULLA.com.
About the Clinical Trial
In a clinical study, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate/ethinyl estradiol tablets, for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for norethindrone acetate/ethinyl estradiol capsules was 1.82 (95% CI: 0.59-4.25).
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 and those 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.
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 pre-diabetic 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.