Ortho Evra is a contraceptive skin patch containing a combination of female hormones (ethinyl estradiol and norelgestromin) that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ortho Evra skin patches are used as contraception to prevent pregnancy.

Ortho Evra may also be used for purposes not listed in this medication guide.

Your risk of serious blood clot may be higher with the use of Ortho Evra skin patches than with the use of birth control pills.

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack while using Ortho Evra. You should not use Ortho Evra if you smoke and are older than 35 years of age.

You should not use Ortho Evra if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, or if you have ever had breast or uterine cancer, a heart attack, a stroke, or a blood clot.

Do not use Ortho Evra if you are pregnant or if you have recently had a baby.

Before taking this medicine

Using Ortho Evra can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using birth control. Your risk is also high when you restart this medicine after not using for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use Ortho Evra if you smoke and are over 35 years old.

Do not use Ortho Evra if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before using Ortho Evra.

You should not use Ortho Evra if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;

• history of heart attack, stroke, or blood clot;

• heart problems such as uncontrolled valve disorder, or a rhythm disorder that causes blood clots in the heart;

• an inherited blood-clotting disorder that causes your blood to clot more than normal;

• untreated or uncontrolled high blood pressure;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• liver disease or cancer; or

• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35.

Your risk of serious blood clot may be higher with the use of Ortho Evra skin patches than with the use of birth control pills.

To make sure Ortho Evra is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;

• a history of depression;

• gallbladder disease;

• diabetes; or

• a history of jaundice caused by pregnancy or birth control pills.

The hormones in Ortho Evra skin patches can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast-feeding a baby.

Use Ortho Evra patches exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use more skin patches or wear them for longer than recommended by your doctor. You will apply your first patch on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

Place the Ortho Evra patch on your skin and press it into place firmly for 10 seconds. Make sure the edges stick well. You will wear the patch for a full week.

Apply the Ortho Evra patch to clean, dry skin on any of these areas: the outside of your upper arm, your stomach, your buttocks, or your upper back. Do not apply the patch to skin that is broken or irritated, or to a skin area that may be rubbed by tight clothing (such as a waistband).

Remove the patch and apply a new one on the same day each week for three weeks in a row. At the end of the third week, remove the patch and do not apply a new one for 7 full days. Your period should start during this time Do not allow more than 7 days to pass before starting your next 3-week patch cycle..

Check your Ortho Evra patch every day to make sure it is sticking well. If a patch comes loose or falls off, throw it away and apply a new one. You may need to use back-up birth control, such as condoms or a spermicide, if a patch has been off for more than 24 hours. Follow your doctor's instructions.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using Ortho Evra for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

While using Ortho Evra, you will need to visit your doctor regularly.

After removing a skin patch fold it in half, sticky side in, and throw it away in a place where children and pets cannot get to it. Do not flush a used patch down the toilet.

Store the skin patches at room temperature away from moisture and heat. Do not freeze or refrigerate. Keep each patch in its foil pouch until you are ready to apply it.

Usual Adult Dose for Contraception:

The initial dosage of Ortho Evra patches for contraception is the placement of one patch on the skin of the upper outer arm, or abdomen, or buttocks, weekly for 3 weeks (21 total days), which is to remain in place for 7 days, the fourth week is drug free.

A new Ortho Evra patch is placed on the skin one-week after the last patch was removed. Regardless of withdrawal bleed presence, the new transdermal patch is placed on the skin the same day (at any time) as it was done in the previous cycle.

If an Ortho Evra patch is partially or completed detached for less than 1 day (up to 24 hours), reapply it to the same place or replace it with a new patch immediately. No backup contraception is needed. If this event occurs for more than 1 day (24 hours or more), or if the woman is not sure how long the patch has been detached, she should stop the current contraceptive cycle and start a new cycle immediately by applying a new patch. Backup contraception, such as condoms, spermicide, or diaphragm, must be used for the first week of the new cycle.

In women switching from a combination oral contraceptive, begin use of the patch on the first day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active (hormone-containing) tablet, pregnancy must be ruled out. If the patch is placed later than the first day of withdrawal bleeding, but within the 7 days from the last oral active tablet, a second method of contraception (non-hormonal) should be added for the first 7 days.

In women with a miscarriage or a complete first trimester abortion, begin use of the patch immediately. An additional method of contraception would not be needed if therapy is started immediately.

In women who choose not to breast-feed after childbirth, begin use of the Ortho Evra patch no sooner than 4 weeks after childbirth. Postpartum women who have not had a period should add a second method of contraception (non-hormonal) for the first 7 days of patch use.

Using Ortho Evra can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using birth control. Your risk is also high when you restart this medicine after not using for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use Ortho Evra if you smoke and are over 35 years old.

Do not use Ortho Evra if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before using Ortho Evra.

You should not use Ortho Evra if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;

• history of heart attack, stroke, or blood clot;

• heart problems such as uncontrolled valve disorder, or a rhythm disorder that causes blood clots in the heart;

• an inherited blood-clotting disorder that causes your blood to clot more than normal;

• untreated or uncontrolled high blood pressure;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• liver disease or cancer; or

• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35.

Your risk of serious blood clot may be higher with the use of Ortho Evra skin patches than with the use of birth control pills.

To make sure Ortho Evra is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;

• a history of depression;

• gallbladder disease;

• diabetes; or

• a history of jaundice caused by pregnancy or birth control pills.

The hormones in Ortho Evra skin patches can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast-feeding a baby.

If you forget to change your Ortho Evra patch at the end of the week, change it as soon as you remember. If it has been 24 hours or longer since your scheduled patch change, apply a new patch and start the cycle over (3 weeks wearing a weekly patch,1 week off). Do not use extra patches to make up the missed dose.

Missing a dose increases your risk of becoming pregnant and you may need to use back-up birth control. Follow the weekly patch schedule closely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not smoke while using Ortho Evra, especially if you are older than 35 years of age.

Grapefruit and grapefruit juice may interact with ethinyl estradiol and norelgestromin and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Avoid using creams, lotions, powders, or other medications on the skin where you apply the patch, or it may not stick to your skin.

Ortho Evra will not protect you from sexually transmitted diseases - including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Get emergency medical help if you have any signs of an allergic reaction to Ortho Evra skin patches: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Ortho Evra and call your doctor at once if you have:

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with balance, sudden vision loss;

• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• a change in the pattern or severity of migraine headaches;

• swelling in your hands, ankles, or feet;

• a breast lump; or

• symptoms of depression - sleep problems, weakness, tired feeling, mood changes.

Common Ortho Evra side effects may include:

• nausea, stomach pain;

• breast tenderness or swelling;

• headache, anxiety, mood changes;

• skin irritation, redness, itching, or swelling where the patch was worn;

• menstrual cramps; or

• irregular vaginal bleeding or spotting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ortho Evra, especially:

• acetaminophen, ascorbic acid (vitamin C);

• antifungal medicine - fluconazole, itraconazole, ketoconazole, voriconazole;

• cholesterol-lowering medicines - atorvastatin, rosuvastatin; or

• HIV or AIDS medicines - atazanavir, etravirine, indinavir.

This list is not complete. Other drugs may interact with Ortho Evra, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make Ortho Evra less effective, which may result in pregnancy. Not all possible interactions are listed in this medication guide.