INDICATIONS AND USAGE

Beyaz is an estrogen/progestin COC containing a folate, indicated for use by women to:

• prevent pregnancy. (1.1)
• treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2)
• treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3)
• raise folate levels in women who choose to use an oral contraceptive for contraception. (1.4)

DOSAGE AND ADMINISTRATION

• Take one tablet daily by mouth at the same time every day. (2.1)
• Tablets must be taken in the order directed on the blister pack. (2.1)

DOSAGE FORMS AND STRENGTHS

Beyaz consists of 28 film-coated, biconvex tablets in the following order (3):

• 24 pink tablets, each containing 3 mg drospirenone (DRSP), 0.02 mg ethinyl estradiol (EE) as betadex clathrate and 0.451 mg levomefolate calcium
• 4 light orange tablets, each containing 0.451 mg levomefolate calcium

CONTRAINDICATIONS

• Renal impairment or adrenal insufficiency (4)
• A high risk of arterial or venous thrombotic diseases (4)
• Undiagnosed abnormal uterine bleeding (4)
• Breast cancer or other estrogen- or progestin-sensitive cancer (4)
• Liver tumors or liver disease (4)
• Pregnancy (4)

WARNINGS AND PRECAUTIONS

• Vascular risks: Stop Beyaz if a thrombotic 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. (5.1)
• Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium level during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium. (5.2, 7.3)
• Liver disease: Discontinue Beyaz if jaundice occurs. (5.4)
• High blood pressure: Do not prescribe Beyaz for women with uncontrolled hypertension or hypertension with vascular disease. (5.5)
• Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Beyaz. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. (5.7)
• Headache: eva luate significant change in headaches and discontinue Beyaz if indicated. (5.8)
• Uterine bleeding: eva luate irregular bleeding or amenorrhea. (5.9)

ADVERSE REACTIONS

• The most frequent (≥ 2%) adverse reactions in contraception, acne and folate clinical trials were: headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%).
• The most frequent (≥ 2%) adverse reactions in PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).

To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

• Drugs or herbal products that induce certain enzymes (e.g., CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. (7.1)

USE IN SPECIFIC POPULATIONS

• Nursing mothers: Not recommended; can decrease milk production. (8.3)