The U.S. Food

and Drug Administration (FDA) has approved a new oral contraceptive (OC), Safyral (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets). In women who choose an OC for birth control, Safyral raises folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking Safyral or shortly after discontinuing it. Safyral provides the birth control Yasmin (drospirenone 3 mg/ ethinyl estradiol 30 mcg) with 451 mcg levomefolate calcium, which is a B vitamin.

Safyral Patient Information

WARNING TO WOMEN WHO SMOKE

Do not use Safyral if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

What Is Safyral?

Safyral is a birth control pill. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. Safyral also contains levomefolate calcium, which is a B vitamin.

The progestin drospirenone may increase potassium. Therefore, you should not take Safyral if you have kidney, liver or adrenal disease because this could cause serious heart and health problems. Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether Safyral is right for you, and during the first month that you take Safyral, you should have a blood test to check your potassium level.

• NSAIDs (ibuprofen [Motrin, Advil], naproxen [Aleve and others] when taken long-term and daily for treatment of arthritis or other problems)

• Potassium-sparing diuretics (spironolactone and others)

• Potassium supplementation

• ACE inhibitors (Capoten, Vasotec, Zestril and others)

• Angiotensin-II receptor antagonists (Cozaar, Diovan, Avapro and others)

• Heparin

• Aldosterone antagonists

Safyral may also be taken by women who elect to use an oral contraceptive, to provide folate supplementation. It is recommended that women of reproductive age supplement their diet with 0.4 mg (400 mcg) of folic acid daily to lower their risk of having a pregnancy with a rare type of birth defect (known as a neural tube defect). The amount of folate contained in Safyral supplements folate in the diet to lower this risk should you become pregnant while taking the drug or shortly after stopping it.