ORTHO EVRA(R) Prescribing Informati...(ation about ORTHO EVRA please visit A HR...),Health

Important Safety Information

Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use the contraceptive patch are strongly advised not to smoke.

The pharmacokinetic (PK) profile for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations (60% higher) and lower peak concentrations (25% lower) of ethinyl estradiol (EE) compared with an oral contraceptive containing 35 mcg EE. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 35 mcg EE. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism. (See CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives, BOLDED WARNING in the Package Insert).

The results of epidemiologic studies evaluating the risk of venous thromboembolism (VTE) among women using ORTHO EVRA compared to those using oral contraceptives containing 30-35 mcg EE and either levonorgestrel or norgestimate reported odds ratios ranging from 0.9 (no increase in risk) to 2.4 (approximate doubling of risk).

The Patch does not protect against HIV or sexually transmitted diseases.

Please see full U.S. Prescribing Information at http://www.orthoevra.com.

About Ortho Women's Health & Urology(TM)

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