Norethindrone acetate/ethinyl estradiol

FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. FEMLYV is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m 2 has not been evaluated

CHCs lower the risk of becoming pregnant primarily by suppressing ovulation.

• Place one FEMLYV orally disintegrating tablet (ODT) on the tongue, allow to disintegrate and then follow with 8 oz. (240 mL) of water. • The tablets can also be swallowed whole with 8 oz. (240 mL) of water. • Take at the same time daily without regards to meals. • Take ODTs in the order directed on the blister pack

FEMLYV is contraindicated in females who are known to have or develop the following conditions: • A history of, increased risk for, or current arterial or venous thrombotic/thromboembolic diseases. Examples include women who are known to: • Smoke, if 35 years of age and older • Have current or history of deep vein thrombosis or pulmonary embolism • Have cerebrovascular disease • Have coronary artery disease • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) • Have inherited or acquired hypercoagulopathies • Have uncontrolled hypertension or hypertension with vascular disease…

Boxed warning (cigarette smoking and serious cardiovascular events): Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including FEMLYV, are contraindicated in females who are over 35 years of age and smoke. • Thromboembolic Disorders and Other Vascular Problems: Discontinue FEMLYV if a thrombotic event occurs. Discontinue at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider all cardiovascular risk factors before initiating in any female, particularly in the presence of multiple risk factors.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke • Vascular events • Liver disease • The most common adverse reactions in clinical trials (≥2%) were: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.

• CYP3A Inducers: May lead to contraceptive failure and/or increase breakthrough bleeding. Avoid concomitant use. If concomitant use is unavoidable, use a back-up method or alternative method of contraception during co-administration and up to 28 days after discontinuation of the CYP3A inducer. • See Full Prescribing Information for additional clinically significant drug interactions

Storage Conditions Store at 20°C to 25º C (68°F to 77º F), excursions permitted to 15°C to 30º C (59°F to 86º F).