Levonorgestrel And Ethinyl Estradiol And Ferrous Fumarate

1 INDICATIONS AND USAGE Joyeaux is indicated for use by females of reproductive potential to prevent pregnancy. Joyeaux is a progestin/estrogen COC 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 )] Adverse reactions commonly reported by COC users are: • Irregular uterine bleeding • Nausea • Breast tenderness • Headache Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC at 844-XIROMED (844-94...

8.1 Pregnancy Risk Summary Joyeaux is contraindicated in pregnancy because there is no reason to use combined hormonal contraceptives (CHCs) in pregnancy. Discontinue Joyeaux if pregnancy occurs. Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use COCs during early pregnancy (See Data ) . 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 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 are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )] . 5 WARNINGS AND PRECAUTIONS • Thrombotic Disorders and Other Vascular Problems : Stop Joyeaux if a thrombotic event occurs. Stop 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 ( 5.1 ) • Liver disease : Discontinue Joyeaux if jaundice occurs ( 5.2 ) • High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Joyeaux if blood pressure rises significantly. ( 5.4 ) • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Joyeaux. 4 CONTRAINDICATIONS Joyeaux is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic disease.