Why is Ortho Evra prescribed?

Ortho Evra is a contraceptive skin patch. It contains estrogen and progestin, the same hormones found in many birth control pills. Fertility depends on regular fluctuations in the levels of these hormones. Contraceptives such as Ortho Evra reduce fertility by eliminating the fluctuations. Once applied to the skin, the Ortho Evra patch releases a steady supply of estrogen and progestin through the skin and into the bloodstream.

Most important fact about Ortho Evra

Cigarette smoking increases the risk of serious heart-related side effects (stroke, heart attack, blood clots, etc.) in women who use hormonal contraceptives. This risk increases with heavy smoking (15 or more cigarettes per day) and with age. There is an especially significant increase in heart disease risk in women over 35 years old who smoke and use hormonal birth control. Therefore, women who use Ortho Evra are strongly advised not to smoke.

How should you take Ortho Evra?

You should use three separate Ortho Evra patches during each 4-week menstrual cycle. Wear one patch a week for the first 3 weeks, then spend the fourth week patch-free. Your menstrual period should start during the fourth week.

• If you miss a dose...
  If your patch becomes loose or falls off for less than 1 day, try to stick it back on, or apply a new patch immediately. If it's been missing for more than 1 day, or you're not sure how long it's been off, there's a chance you could become pregnant and you should use a backup method of birth control. Check the Ortho Evra patient information for instructions.

If you forget to change your patch at any time during the 4-week cycle, check the Ortho Evra patient information for instructions.

• Storage instructions...
  Keep patches in their protective pouches until you're ready to wear them. Store at room temperature. Do not store in the refrigerator or freezer.

Used patches still contain some active hormones. Fold each patch so that it sticks to itself before throwing it away. Do not flush the used patch down the toilet.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue using Ortho Evra.

• Side effects of Ortho Evra may include:
  Abdominal pain, application site reaction, breast tenderness or enlargement, headache, menstrual cramps, mood swings, nausea and/or vomiting, upper respiratory infection

In addition, side effects associated with birth control pills may also apply to Ortho Evra. See the list of side effects in the profile labeled "Oral Contraceptives."

Why should Ortho Evra not be prescribed?

Do not use Ortho Evra if you are pregnant (or think you might be). Also avoid it if the ingredients give you an allergic reaction or you suffer from headaches with neurological symptoms such as visual disturbances (pulsing lights and blind spots) and temporary numbness.

If you have ever had breast cancer or cancer in the reproductive organs or liver tumors, you should not take Ortho Evra. Avoid it, too, if you have or have ever had a stroke, heart disease, liver disease, angina (severe chest pain), or blood clots. It is also not recommended for women with significant high blood pressure or diabetes-related complications of the kidneys, eyes, nerves, or blood vessels.

Women who have had pregnancy-related jaundice (yellowing of the skin or whites of eyes) or jaundice stemming from previous use of hormonal contraceptives should not take Ortho Evra. You should also avoid it if you have undiagnosed and/or unexplained abnormal vaginal bleeding, or if you need prolonged bed rest after major surgery.

Do not use Ortho Evra if you are already taking birth control pills. Avoid the drug, too, if you are breastfeeding.

Special warnings about Ortho Evra

Hormonal contraceptives, including Ortho Evra, should be used with caution if you are over 40 years old; smoke tobacco; have liver, heart, gallbladder, or kidney disease; have high blood pressure, high cholesterol, diabetes, or epilepsy; or tend to be seriously overweight. Caution is also advised if you have blood circulation problems or have had a heart attack or stroke in the past. Be cautious, too, if you have problems with depression, migraine or other headaches, irregular menstrual periods, or visual disturbances.

There have been conflicting reports on whether using hormonal contraceptives increases the risk of breast cancer. It appears that using hormonal contraceptives may slightly increase the chance of breast cancer, particularly if they're used before age 20. After hormonal contraceptives are stopped, the risk begins to go back down. If you use Ortho Evra, you should examine your breasts monthly and have yearly breast exams by a doctor. Also tell your doctor if you have a family history of breast cancer or if you have had breast nodules, fibrocystic breast disease, or an abnormal mammogram.

You should also be aware that some experts think hormonal contraceptives may increase the risk of cervical cancer. This remains controversial, however. Many doctors think other factors are to blame.

Since the blood's clotting ability may be affected by hormonal contraceptives, your doctor may take you off Ortho Evra prior to surgery or during a period of prolonged bed rest. You should wait at least 4 weeks after having a baby before starting Ortho Evra; and if you're breastfeeding, wait until the child is weaned before starting the drug. If you are recovering from a second trimester miscarriage or abortion, talk to your doctor before using Ortho Evra.

If you develop a migraine or severe headache that does not let up or keeps recurring while you are taking Ortho Evra, check with your doctor. You may need to switch to a different form of birth control.

You should also be aware that hormonal contraceptives have been know to cause rare cases of noncancerous—but dangerous—liver tumors. In people prone to high cholesterol and similar problems, hormonal contraceptives have been known to raise triglyceride levels, leading to pancreatitis.

If you miss a menstrual period but have followed the Ortho Evra regimen correctly, contact your doctor but do not stop using the patches. If you miss a period and have not followed the regimen correctly, or if you miss two consecutive periods, you may be pregnant; stop using the patches and check with your doctor immediately to see if you are pregnant. Use another form of birth control while you're off the patch.

Ortho Evra may be less effective in women who weigh more than 198 pounds; if you fall into this category, ask your doctor which form of birth control is best for you.

Hormonal contraceptives do not protect against HIV infection (AIDS) or any other sexually transmitted disease. If there is a danger of infection, use a latex condom in addition to Ortho Evra.

Be sure to tell the doctor that you are taking Ortho Evra before having lab tests done, since certain blood tests may be affected by hormonal contraceptives.

Possible food and drug interactions when taking Ortho Evra

If hormonal contraceptives are taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Ortho Evra with the following:

Acetaminophen
Antibiotics such as ampicillin and rifampin
Anticonvulsants such as carbamazepine, felbamate, oxcarbazepine, phenytoin, and topiramate
Aspirin
Atorvastatin
Barbiturates (phenobarbital, secobarbital)
Clofibrate
Cyclosporine
Diabetes drugs such as
Folic acid
Griseofulvin
Itraconazole
Ketoconazole
Morphine
Phenylbutazone
Prednisolone
Protease inhibitors (HIV drugs such as indinavir and nelfinavir)
St. John's wort
Temazepam
Theophylline
Vitamin C

Remember, too, that hormonal contraceptives may affect tests for blood sugar levels and thyroid function and may cause an increase in blood triglyceride levels.