Contraceptive patch. The patch should not be applied to the palm.

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Ortho Evra

A contraceptive patch is a transdermal patch applied to the skin that releases synthetic estrogen and progestin hormones to prevent pregnancy. They are thought to have the same effectiveness as the contraceptive pill. Currently the only publicly available contraceptive patch is marketed under the brand name Ortho Evra. Use of this relatively new contraceptive is increasing rapidly, likely because it combines the high effectiveness of contraceptive pills with a more convenient and easy method of administration. Contraceptive patches are often referred to by the slang term "the patch". more...

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Method of use

In the United States and Canada, Ortho Evra is available only by prescription and is sold in boxes of three patches. Johnson & Johnson is the largest manufacturer of these patches.

A woman applies her first patch onto her upper outer arm, buttocks, abdomen or thigh on either the first day of her menstrual cycle (day 1) or on the first Sunday following that day, whichever she prefers. The day of application is known from that point as patch change day. Seven days later, when patch change day comes again, the woman removes the patch and applies another in its place. This process is repeated again on the next patch change day. On the following patch change day, the patch is removed and not replaced. The woman waits 7 days without a patch in place, and on the next patch change day she applies a new patch.

Backup contraception

If a woman chooses to begin with her patch change day as day 1 of her menstrual cycle, the patch is able to take effect in time to prevent ovulation (see Mechanism of Action below) and no form of backup contraception is needed at all.
- In the case that a woman wishes to begin using the contraceptive patch following a first trimester abortion or miscarriage, patch application can be done immediately afterwards. This can be considered the same as a day 1 start above, and no backup contraception is required.
If a woman chooses to begin with her patch change day as the first Sunday following day 1, it is necessary to use a backup form of contraception such as spermicide or condoms for the first week of patch wear.

Mechanism of action

Contraceptive patches are synthetic hormone contraceptives, similar in action to the contraceptive pill. The contraceptive patch product Ortho Evra contains 0.75 mg ethinyl estradiol and 6.0 mg norelgestromin hormones in a single patch. The gradual release of hormones over the course of each week (approximately 20 µg/day ethinyl estradiol and 150 µg/day norelgestromin) act much like contraceptive pills do. Most commonly ovulation is inhibited entirely, preventing pregnancy. Less often the cervical mucus is thickened, making it more difficult for sperm to cross through the cervix and for fertilization to occur.

Interactions and Contraindications

Contraceptive effectiveness of the patch or any other hormonal contraceptive may be reduced significantly if co-administered alongside various antibiotics, antifungals, anticonvulsants, or other drugs that increase metabolism of contraceptive steroids.

However, despite the interactions with many other antibiotics, a clinical pharamacokinetic drug interaction study showed that oral administration of tetracycline HCl 500 mg for 3 days prior to and 7 days during use of Ortho Evra did not reduce effectiveness of Ortho Evra. This is a significant factor in the common decision to administer tetracycline-derived antibiotics following an abortion (preventatively to fight potential infection) when synthetic hormone contraceptives are to be used afterwards.

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FEATURE/Finally! Real Women Strut Their Stuff On the Catwalk; ORTHO EVRA and The Esteemed Woman Foundation Sponsor First-Ever Every Woman Fashion Show
From Business Wire, 9/18/02

Features Editors

FEATURE...

NEW YORK--(BUSINESS WIRE)--Sept. 18, 2002

There's a new kind of model making her way down the catwalk.

For the first time ever, the prestigious Mercedes-Benz Fashion Week will feature everyday women on the runway. The ORTHO EVRA(TM) Every Woman Fashion Show is a one-of-its kind event giving everyday women the opportunity to walk the catwalk to celebrate the inner beauty of women.

This groundbreaking event was created and sponsored by Ortho-McNeil Pharmaceutical, Inc., maker of ORTHO EVRA, the first and only weekly birth control patch, in conjunction with The Esteemed Woman Foundation, a non-profit organization dedicated to building self-image and inner strength among women.

On September 20th at the Bryant Park Pavilion in New York City, ten women will take the fashion world by storm as they share their inspirational stories and showcase what it means to be truly beautiful inside and out. These remarkable women were selected by Ortho-McNeil Pharmaceutical, Inc. and The Esteemed Woman Foundation as they represent and exemplify real women across America. Through their personal stories, the women will show how they've discovered and embraced their inner strength and gained the confidence to control their destiny. The women will wear a variety of fall fashions donated by A-list designers.

Suzie Galler, Founder of the Esteemed Woman Foundation and renowned women's film producer, and Mary Wright, Executive Director of the Foundation, developed the models' "intimate portraits" and helped prepare them for their runway debut. As event co-host, Ms. Galler will help bring these inspirational stories to life on stage.

Ms. Galler's co-host is Elisabeth Filarski a "Survivor: The Australian Outback," finalist and footwear designer. Her show, "The Look for Less" on the Style Network is devoted to finding style on a budget. Ms. Filarski is also hosting Style Network's official daily coverage of Mercedes-Benz Fashion Week.

Renowned fashion show producer, Rand Burrus, co-founder of the RAND M. Productions, is the driving force behind this production. Rand has also developed stellar programs for A-list designers including BCBG Max Azria, Armani and Betsey Johnson.

ORTHO EVRA

ORTHO EVRA was developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and is marketed by Ortho-McNeil Pharmaceutical, Inc. ORTHO EVRA, the first weekly birth control patch, combines the effectiveness of the Pill - 99 percent when used correctly - with convenient once-a-week dosing.

ORTHO EVRA is indicated for the prevention of pregnancy. ORTHO EVRA is not for everyone. Women should speak with their healthcare professional about which birth control method is right for them.

The contraceptive patch contains hormones similar to those in birth control pills. Hormonal contraceptives are not for everybody. Most side effects of the contraceptive patch are not serious and those that are, occur infrequently. Serious risks, which can be life-threatening, include blood clots, stroke or 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 hormonal contraceptives are strongly advised not to smoke. Some women should not use the contraceptive patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. The contraceptive patch does not protect against HIV or other sexually transmitted diseases.

Ortho-McNeil is a pioneer in contraception and a leader in women's healthcare. Ortho-McNeil offers the broadest range of prescription birth control options, including nine birth control pills, a leading intrauterine device (IUD), diaphragms and now the first birth control patch. The company also markets prescription pharmaceutical products in other therapeutic categories, including central nervous system, urology, infectious disease, analgesics and wound healing. For more information, visit www.ortho-mcneil.com.

Esteemed Woman Foundation

The Esteemed Woman Foundation was created to empower women to recognize and build upon their inner resources, strengths and ability to control their own destiny, and give them the confidence to proudly proclaim, "I Am An Esteemed Woman." The goal of the organization is to encourage women of all ages to explore and build their self-image through interactive workshops, design and publication of written materials and production of media programs and events, which raise awareness of these important issues. For more information about the Esteemed Woman Foundation call 1-877-6-ESTEEM or visit www.esteemedwoman.com.

Style. "The Look For Less"

"The Look For Less" is the show for any woman who loves a bargain and each episode is devoted to finding style on a budget. Whether it's this season's equestrian chic or the glossy glamour lip color from the runways, host Elisabeth Filarski will show viewers how to get fashion's hottest looks at a cool price. She'll scour the sale racks at the trendiest boutiques, dig through vintage store bins and find hidden treasures at local drugstores before putting everything together, offering creative tips and clever ideas. "The Look For Less" puts the fun into fashion and makes bargain shopping a sport. For show listings visit www.stylenetwork.com.

(a) Please see full U.S. Prescribing Information enclosed or at www.orthoevra.com

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