Patient Information Sheet
Norlegstromin/ethinyl estradiol (marketed as Ortho Evra)

What is Ortho Evra used for?

Ortho Evra is a contraceptive (birth control) skin patch used to prevent pregnancy. It is called a combination hormonal contraceptive because it contains two hormones, estrogen and progestin. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 

Who should not take Ortho Evra?

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of hormonal birth control methods. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal birth control methods should not smoke. 

Ortho Evra should not be used by women who have a history of: 

• heart attack or stroke 
• blood clots in the legs, lungs (pulmonary embolism), or eyes 
• blood clots in the deep veins of the legs 
• chest pain 
• known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina 
• current unexplained vaginal bleeding 
• yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives 
• liver tumor (benign or cancerous) 
• current or suspected pregnancy 
• severe high blood pressure 
• diabetes with complications of the kidneys, eyes, nerves, or blood vessels 
• an allergy to Ortho Evra or to any of its ingredients 

General Precautions with Ortho Evra:

For the majority of women, Ortho Evra can be used safely. But some women are at high risk of developing certain serious diseases that can be life threatening or may cause temporary or permanent disability or death. The risks associated with using Ortho Evra increase significantly if you: 

• smoke 
• have high blood pressure, diabetes, or high cholesterol 
• have or have had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors

Ortho Evra may be less effective in preventing pregnancy in women weighing more than 198 pounds. 

What should I tell my healthcare provider?

Tell your healthcare provider: 

• about all your medical conditions 
• if you smoke cigarettes 
• about all the medications you take, including prescription and nonprescription medications, vitamins, and herbal supplements. Some medicines can affect Ortho Evra and make it less effective.

What are some possible side effects of Ortho Evra? (This is NOT a complete list of side effects reported with Ortho Evra. Your healthcare provider can discuss with you a more complete list of side effects.)

Some common side effects with combination hormonal contraceptives like Ortho Evra are: 

• breast tenderness and enlargement 
• headache 
• nausea 
• menstrual changes 
• abdominal cramps and bloating 
• vaginal discharge 

Ortho Evra may also cause skin irritation at the application site. 

Reports of new information after Ortho Evra became available:

As a result of further analysis by the FDA and the manufacturer, it has been found that users of Ortho Evra are exposed to about 60% more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the highest blood level of estrogen (peak blood levels) is about 25% lower with Ortho Evra than with typical birth control pills. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious side effects.

For more detailed information about Ortho Evra, ask your healthcare provider and pharmacist.

Labeling for Ortho Evra (9/2006) Instructions for use starts on page 53.

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Date created:  November 22, 2002, updated: September 20, 2006

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