Important Safety Information About BEYAZ, Including Boxed Warning
Patients who should not take Beyaz
Women over 35 years old who smoke should not use Beyaz. Smoking increases the risk of serious cardiovascular side effects from Beyaz use. This risk increases with age and the number of cigarettes smoked.
Beyaz is contraindicated in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other hormone-sensitive cancer, liver tumors (benign or malignant) or liver disease, conditions that predispose to hyperkalemia (ie, renal impairment, hepatic dysfunction, and adrenal insufficiency), or who are pregnant
Know serious risks with Beyaz
- Thromboembolic and Other Vascular Events: Stop Beyaz if an arterial or venous thrombotic event occurs. The risk of venous thromboembolism (VTE) is highest during the first year of combination oral contraceptive (COC) use. This increased risk is greatest after initially starting a COC or restarting the same or a different COC following a 4 week or greater Pill-free interval. Epidemiologic studies suggest drospirenone (drsp®)-containing COCs may be associated with a higher risk of VTE than COCs containing levonorgestrel or some other progestins. These studies reported the risk of VTE ranged from no increase to a 3-fold increase. Before initiating Beyaz in a new COC user or in a woman switching from a contraceptive not containing drsp, consider the risks and benefits of Beyaz in light of her VTE risk (eg, smoking, obesity, family history of VTE)
COC use also increases risk of arterial thromboses (eg, stroke and myocardial infarction), especially in women with risk factors for these events. Use COCs with caution in women with cardiovascular disease risk factors. If feasible, stop Beyaz at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Beyaz no earlier than 4 weeks after delivery in women not breastfeeding
- Hyperkalemia: Beyaz contains drospirenone that has the potential for hyperkalemia in high-risk patients and is contraindicated in patients with conditions that predispose to hyperkalemia. Check serum potassium level during the first treatment cycle in women who receive long-term treatment with medications that may increase serum potassium (eg, ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs)
- Liver Disease: Discontinue Beyaz if jaundice develops
High Blood Pressure (BP): Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs. Monitor BP in women with well-controlled hypertension and stop Beyaz if BP rises significantly. BP may increase in COC users, more likely occurring in older women and with extended use
Gallbladder Disease: Studies suggest a small increased relative risk of developing gallbladder disease among COC users
Carbohydrate and Lipid Metabolic Effects: Monitor prediabetic and diabetic COC users. Consider alternative contraception for women with uncontrolled dyslipidemia
Headache: If a Beyaz user develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Beyaz if indicated
Bleeding Irregularities: Evaluate irregular bleeding or amenorrhea; check for causes such as pregnancy or malignancy
Folates may mask vitamin B12 deficiency
Counsel patients that Beyaz does not protect against HIV infection and other sexually transmitted diseases
Serious adverse reactions in clinical trials:
Cervix carcinoma stage 0, cervical dysplasia, and migraine
Most common adverse reactions (>=2%) in clinical trials:
In contraception, moderate acne, and folate clinical trials: headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%), and breast pain/tenderness (3.2%)
In PMDD clinical trials: 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%)
Drug interactions (see Prescribing Information of concomitant drugs)
Effects of Other Drugs on COCs: Drugs or herbal products that induce certain enzymes (eg, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternate method of contraception during use and for 28 days following discontinuation of concomitant use. Certain drugs (eg, atorvastatin, CYP3A4 inhibitors) may increase plasma levels of COCs. HIV/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors may increase or decrease plasma levels of COCs. There have been reports of pregnancy while taking hormonal contraceptives and antibiotics concomitantly
Effects of COCs on Other Drugs: COCs may inhibit or induce metabolism of other drugs (eg, lamotrigine). Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with COC use
Effects on Serum Potassium: See hyperkalemia information on adjacent page
Effects of Folates on Other Drugs: Folates may decrease the pharmacological effect of certain antifolate drugs
Effects of Other Drugs on Folates: Several drugs (eg, methotrexate and sulfasalazine, cholestyramine, certain antiepileptics) may reduce folate levels via various mechanisms
Please see provided full Prescribing Information about Beyaz, including Boxed Warning.
* The health authorities cited do not endorse specific products or brands.
1. Centers for Disease Control and Prevention. Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR. 1992;41(RR-14):1-7.
2. U.S. Preventive Services Task Force. Folic acid for the prevention of neural tube defects: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;150:626-631.
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All other trademarks are the property of their respective owners.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.