Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol

1 INDICATIONS AND USAGE CAMRESE ® is indicated for use by females of reproductive potential to prevent pregnancy. CAMRESE is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (≥5%) in clinical trials for CAMRESE are irregular and/or heavy uterine bleeding, weight gain, and acne. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, CAMRESE should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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 , including CAMRESE, are contraindicated in women who are over 35 years of age and smoke. [See Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. 5 WARNINGS AND PRECAUTIONS Vascular risks: Stop if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. ( 5.1 , 5.5 ) Liver disease: Discontinue if jaundice occurs. ( 5.2 ) Hypertension: If used in females with well-controlled hypertension, monitor blood pressure and stop if blood pressure rises significantly. ( 5.3 ) Gallbladder disease: May cause or worsen gallbladder disease. ( 5.6 ) Adverse carbohydrate and lipid metabolic effects: Monitor glucose in prediabetic and diabetic women taking CAMRESE. 4 CONTRAINDICATIONS CAMRESE is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )].