ORTHO EVRA















	For Prescribers

	Full US Prescribing Info

ORTHO EVRA is the first birth control patch to be approved by the US Food and Drug Administration (FDA).

ORTHO EVRA is an easy-to-use, safe and effective birth control option for women. It is the first weekly form of birth control that's as effective as the Pill. ORTHO EVRA is 99 percent effective when used correctly.

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 the enclosed full Prescribing Information.

Important Safety Information
Serious as well as minor side effects have been reported with the use of the Patch. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack, blood clots, or stroke, as well as those who are or may be pregnant.

Hormones from ORTHO EVRA^® get into the blood stream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA^® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA^® use compared with use of birth control pills. Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA^® or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30-35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA^® compared to women using birth control pills.

You should discuss with your healthcare professional whether ORTHO EVRA^® is a good method of contraception for you. The Patch does not protect against HIV or sexually transmitted diseases.

Please see the Full Product Information.

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Capitalized product names are registered trademarks of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

This information is intended for use by our customers, patients and healthcare professionals in the United States only. Ortho Women's Health & Urology™, Division of Ortho-McNeil-Janssen Pharmaceuticals recognizes that the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside the United States.

Last Modified Sep 05 2008 at 15:11:45 EDT

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