Pharmacology Update

Drospirone/Ethinyl Estradiol/Levomefolate Calcium Tablets (Beyaz™)

By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD. Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; and Assistant Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Drs. Elliott and Chan report no financial relationship to this field of study.

The first oral contraceptive combined with a folate has been approved by the FDA. The new product is the same contraceptive combination found in Bayer's popular oral contraceptive Yaz®, along with levomefolate calcium, a metabolite of folic acid. The combination is marketed by Bayer HealthCare Pharmaceuticals as Beyaz™.

Indications

DRO/EE/FOL is indicated for the prevention of pregnancy. It is also indicated for the treatment of the symptoms of premenstrual dysphoric disorder, moderate acne, as well as to raise folate levels in oral contraceptive users.1

Dosage

The recommended dose is one tablet daily at the same time of day. Drospirenone 3 mg and ethinyl estradiol 2 mg is taken for 24 days and levomefolate calcium 0.451 mg is taken for 28 days.

Potential Advantages

Beyaz provides folate supplementation for women who may choose to become pregnant after discontinuation of the oral contraceptive.

Potential Disadvantages

The activity of folate may be reduced by certain drugs such as methotrexate, sulfasalazine, bile-sequestering agents, and certain epileptics (e.g., carbamazepine, phenytoin, phenobarbital, primidone, and valproic acid).1 Drospirenone may increase serum potassium.

Comments

The efficacy of drospirenone and ethinyl estradiol has been established with the combination product, Yaz. The combination of Yaz and levomefolate calcium produced higher plasma and red blood cell folate levels than Yaz plus folate-fortified food. Mean increases in value were approximately 35%.

Clinical Implications

The Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force recommend that women of childbearing age take at least 0.4 mg of folic acid daily to reduce the risk of neural tube defect in the infant. Despite these recommendations and mandated folate fortification of enriched cereal gain products, a recent analysis of data from the National Health and Nutritional Examination Survey indicated that only 24% of nonpregnant U.S. women aged 15-44 years consumed the recommenced amount of folic acid.2

In addition, women ages 18-24 years, who account for approximately one-third of all births, had the least awareness regarding folic acid consumption and the lowest reported daily use of supplements containing folic acid compared to other age groups.3 Beyaz is combination oral contraceptive that is "fortified" with levomefolate. It offers another option for women who wish to use a contraceptive as well as to raise their folate levels without taking folic acid supplement. Other than the convenience, there is no advantage over taking an oral contraceptive without a folic acid supplement.

References

1. Beyaz Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; September 2010.

2. Tinker SC, et al. Folic acid intake among U.S. women aged 15-44 years, National Health and Nutrition Examination Survey, 2003-2006. Am J Prev Med 2010;38: 534-542.

3. Centers for Disease Control and Prevention. Use of supplements containing folic acid among women of childbearing age--United States, 2007. MMWR Morb Mortal Wkly Rep 2008;57:5-8.