Ortho Evra

Ortho Evra is a prescription medication used to prevent pregnancy. It contains two medications, norelgestromin and ethinyl estradiol, which belong to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation and by altering cervical mucus and the lining of the uterus.

This medication comes in the form of a skin patch to be placed on the skin each week for the first 3 weeks of the menstrual cycle.

Common side effects include nausea, breast discomfort, and headache.

Ortho Evra is a prescription skin patch used to prevent pregnancy in women.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

1. Most Common Side Effects

The most common side effects of Ortho Evra include nausea, breast symptoms (discomfort, engorgement, or pain), headache, and problems where the patch has been on the skin.

2. Skin Irritation

Skin irritation, redness, pain, swelling, itching or rash may occur at the site of application. If this occurs, the patch may be removed and a new patch may be applied to a new location until the next Change Day. Single replacement patches are available from pharmacies with a prescription.

3. Vaginal Bleeding

Irregular vaginal bleeding or spotting may occur while you are using Ortho Evra. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding may occur during the first few months of contraceptive patch use but may also occur after you have been using the contraceptive patch for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue using your contraceptive patches on schedule. If the bleeding occurs in more than a few cycles or lasts for more than a few days, talk to your healthcare professional.

4. Problems Wearing Contact Lenses

If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your healthcare professional.

5. Fluid Retention or Raised Blood Pressure

Edema (fluid retention) with swelling of the fingers or ankles and/or a rise in blood pressure may occur with the use of hormonal contraceptives. If you experience fluid retention, contact your healthcare professional.

6. Melasma

A spotty darkening of the skin is possible, particularly of the face. This may persist after use of hormonal contraceptives is discontinued.

7. Other Side Effects

Other side effects include weight gain, increased appetite, feeling dizzy, migraine, stomach pain or bloating, vomiting, diarrhea, abnormal taste, acne, muscle spasms, vaginal infections, feeling tired or unwell, painful or heavy periods or periods more frequent than normal, uterine cramps, vaginal discharge and mood problems such as depression, mood swings or anxiety.

Hormonal contraceptives may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures so your doctor may need to adjust the dose. Some medicines and herbal products may make your hormonal contraceptive less effective, including:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

Blood levels of estrogen from this hormonal contraceptive may be increased if you take certain medicines or drink grapefruit juice. Also, your hormonal contraceptive may make some other medicines less effective. As with all prescription products, you should notify your doctor of any other medications and herbal products you are taking or plan to take. You may need to use a barrier contraceptive when you take medicines or products that can make hormonal contraceptives less effective.

Do not use Ortho Evra if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from hormonal contraceptives, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Some women should not use the Ortho Evra contraceptive patch. For example, you should not use Ortho Evra if you are pregnant or think you may be pregnant. You should also not use Ortho Evra if you have any of the following conditions:

• A history of heart attack or stroke
• Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
• A history of blood clots in the deep veins of your legs
• An inherited problem that makes your blood clot more than normal
• Chest pain (angina pectoris)
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
• Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
• Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives such as norelgestromin/ethinyl estradiol, Norplant, or the birth control pill
• Liver tumor (benign or cancerous)
• Known or suspected pregnancy
• Severe high blood pressure
• Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
• Headaches with neurological symptoms
• Use of oral contraceptives (birth control pills)
• Disease of heart valves with complications
• Need for a prolonged period of bed rest following major surgery
• An allergic reaction to any of the components of norelgestromin/ethinyl estradiol

Tell your healthcare professional if you have ever had any of these conditions. Your healthcare professional can recommend a non-hormonal method of birth control.

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 useOrtho 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 norelgestromin/ethinyl estradiol compared to women using birth control pills.

Talk to your healthcare professional about using Ortho Evra if:

• you smoke
• you are recovering from the birth of a baby
• you are recovering from a second trimester miscarriage or abortion
• you are breastfeeding
• you weigh 198 pounds or more
• you are taking any other medications

Also, tell your healthcare professional if you have or have had:

• Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram
• A family history of breast cancer
• Diabetes
• Elevated cholesterol or triglycerides
• High blood pressure
• Migraine or other headaches or epilepsy
• Depression
• Gallbladder disease
• Liver disease
• Heart disease
• Kidney disease
• Scanty or irregular menstrual periods

If you have any of these conditions you should be checked often by your healthcare professional if you use the contraceptive patch.

RISKS OF USING HORMONAL CONTRACEPTIVES, INCLUDING ORTHO EVRA 

The following information is derived primarily from studies of birth control pills. Since Ortho Evra contains hormones similar to those found in birth control pills, it is expected to be associated with similar risks:

1. Risk of Developing Blood Clots

Blood clots and blockage of blood vessels that can cause death or serious disability are some of the most serious side effects of using hormonal contraceptives, including the norelgestromin/ethinyl estradiol contraceptive patch. In particular, a clot in the legs can cause thrombophlebitis, and a clot that travels to the lungs can cause sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.

The risk of venous thromboembolic disease (blood clots in the legs and/or the lungs) may be increased with norelgestromin/ethinyl estradiol compared with that of oral contraceptives containing norgestimate and 35 micrograms of estrogen. You should discuss this possible increased risk with your healthcare professional before using norelgestromin/ethinyl estradiol. 

If you use Ortho Evra and need elective surgery, need to stay in bed for a prolonged illness or injury or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping Ortho Evra four weeks before surgery and not using it for two weeks after surgery or during bed rest. You should also not use Ortho Evra soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breastfeeding. If you are breastfeeding, you should wait until you have weaned your child before using Ortho Evra.

2. Heart Attacks and Strokes

Hormonal contraceptives, including Ortho Evra, may increase the risk of developing strokes (blockage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability.

Smoking and the use of hormonal contraceptives including Ortho Evra greatly increase the chances of developing and dying of heart disease. Smoking also greatly increases the possibility of suffering heart attacks and strokes.

3. Gallbladder Disease

Women who use hormonal contraceptives, including Ortho Evra, probably have a greater risk than nonusers of having gallbladder disease.

4. Liver Tumors

In rare cases, combination oral contraceptives can cause benign but dangerous liver tumors. Since Ortho Evra contains hormones similar to those in birth control pills, this association may also exist with Ortho Evra. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer. However, liver cancers are rare.

5. Cancer of the Reproductive Organs and Breasts

Various studies give conflicting reports on the relationship between breast cancer and hormonal contraceptive use. Combination hormonal contraceptives, including Ortho Evra, may slightly increase your chance of having breast cancer diagnosed, particularly after using hormonal contraceptives at a younger age. After you stop using hormonal contraceptives, the chances of having breast cancer diagnosed begin to go back down. You should have regular breast examinations by a healthcare professional and examine your own breasts monthly. Tell your healthcare professional if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram.

Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormone-sensitive tumor.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.

PREGNANCY DUE TO ORTHO EVRA FAILURE

The incidence of pregnancy from hormonal contraceptive failure is approximately one percent (i.e., one pregnancy per 100 women per year) if used correctly. The chance of becoming pregnant increases with incorrect use. If contraceptive patch failure does occur, the risk to the fetus is minimal.

PREGNANCY AFTER STOPPING ORTHO EVRA 

There may be some delay in becoming pregnant after you stop using Ortho Evra, especially if you had irregular menstrual cycles before you used hormonal contraceptives. It may be best to postpone conception until you begin menstruation regularly once you have stopped using Ortho Evra and want to become pregnant.

There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping hormonal contraceptives.

Grapefruit and grapefruit juice may interact with this medication and lead to potentially dangerous effects. Discuss the use of grapefruit products with your healthcare professional.

You should discuss this possible increased risk with your healthcare professional before using Ortho Evra.

Also talk to your healthcare professional about using norelgestromin/ethinyl estradiolOrtho Evra if:

• you smoke
• you are recovering from the birth of a baby
• you are recovering from a second trimester miscarriage or abortion
• you are breastfeeding
• you weigh 198 pounds or more
• you are taking any other medications

Also, tell your healthcare professional if you have or have had:

• Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram
• A family history of breast cancer
• Diabetes
• Elevated cholesterol or triglycerides
• High blood pressure
• Migraine or other headaches or epilepsy
• Depression
• Gallbladder disease
• Liver disease
• Heart disease
• Kidney disease
• Scanty or irregular menstrual periods

If you have any of these conditions you should be checked often by your healthcare professional if you use the contraceptive patch.

You should not use this medication if you are pregnant or think you may be pregnant. However Ortho Evra is not known to cause birth defects when used by accident during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Ortho Evra is excreted in human breast milk or if it will harm your nursing baby.

Ortho Evra keeps you from becoming pregnant by transferring hormones to your body through your skin. The patch must stick securely to your skin in order for it to work properly.

This method uses a 28 day (four week) cycle. You should apply a new patch each week for three weeks (21 total days). You should not apply a patch during the fourth week. Your menstrual period should start during this patch-free week.

Every new patch should be applied on the same day of the week. This day will be your 'Patch Change Day.' For example, if you apply your first patch on a Monday, all of your patches should be applied on a Monday. You should wear only one patch at a time.

On the day after week four ends, you should begin a new four week cycle by applying a new patch.

HOW TO START USING YOUR ORTHO EVRA PATCH FOR THE FIRST TIME

You have two options for starting the patch. Choose which option is right for you:

• First Day Start–Apply your first patch during the first 24 hours of your menstrual period.
• Sunday Start–Wait until the first Sunday after your menstrual period begins. With this option, a non-hormonal backup method of birth control, such as a condom or diaphragm and spermicide, is needed for the first 7 days of the first cycle only. If your period starts on a Sunday, the first patch should be applied that day, and no backup contraception is needed.
• When Switching From the Pill or Vaginal Contraceptive Ring to the Patch-If you are switching from the pill or vaginal contraceptive ring to Ortho Evra, complete your current pill cycle or vaginal ring cycle and apply the first Ortho Evra patch on the day you would normally start your next pill or insert your next vaginal ring. If you do not get your period within a week after taking the last active pill or removing the last vaginal ring, you may still start the norelgestromin/ethinyl estradiol patch. Check with your healthcare professional to be sure that you are not pregnant. If the patch is applied more than a week after taking the last active pill or removal of the last vaginal ring, a non-hormonal method of birth control should be used at the same time as the patch for the first 7 days of patch use.

CHOOSE A PLACE ON YOUR BODY TO PUT THE PATCH

• The patch may be placed on your upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing. For example, do not place it under the waistband of clothing.
• Do not put the patch on your breasts, on cut or irritated skin, or on the same location as the previous patch.

Before you apply the patch:

• Make sure your skin is clean and dry.
• Do not use lotions, creams, oils, powders, or make-up at the patch site. It may cause the patch to fail to stick properly or to become loose.

HOW TO APPLY THE PATCH

Tear open the pouch at the top edge. Peel open the foil pouch that contains the patch and its clear plastic cover. Gently remove the patch and its plastic cover together from the pouch, being careful not to separate the patch from the clear plastic cover. Using a fingernail, peel away half of the clear plastic. Avoid touching the sticky surface with your fingers. Apply the sticky side of the patch on the skin you have cleaned and dried. Remove the other half of the clear plastic and attach the entire patch to your skin. 

• Press firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch adheres to your skin.
• Run your fingers over the entire surface area to smooth out any "wrinkles" around the outer edges of the patch.

• Check your patch every day to make sure all edges are sticking correctly.

Never cut, damage or alter the patch in any way.

When to change patch:

• The patch works for seven days (one week). Apply a new patch on the same day each week (your Patch Change Day) for 3 weeks in a row. Make sure you have removed your old patch prior to applying the new patch.
• During week 4, DO NOT wear a patch. Make sure you removed your old patch. (Your period should begin during this week).
• Following week 4, repeat the cycle of three weekly applications followed by a patch-free week.

The patch must stick securely to your skin to work properly. Do not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it.

If a patch edge lifts up:

• Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch adheres to your skin. Run your fingers over the entire surface area to smooth out any "wrinkles" around the edges of the patch.
• If your patch does not stick completely, remove it and apply a replacement patch. (Ask your healthcare professional for a replacement patch prescription so you always have an extra patch available).
• Do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing.

If your patch has been off or partially off:

• For less than 1 Day, try to reapply it. If the patch does not adhere completely, apply a new patch immediately. (No backup contraception is needed and your Patch Change Day will stay the same).
• For more than 1 Day or if you are not sure for how long, you may become pregnant. To reduce this risk, apply a new patch and start a new 4-week cycle. You will now have a new Patch Change Day and MUST USE NON-HORMONAL BACKUP CONTRACEPTION (such as a condom or diaphragm and spermicide) for the first week of your new cycle.

Ortho Evra is a combination transdermal contraceptive that contains norelgestromin and ethinyl estradiol (EE). This system uses a 28-day (four-week) cycle. A new patch is applied each week for three weeks (21 total days). Week Four is patch-free. Withdrawal bleeding is expected during this time.

Every new patch should be applied on the same day of the week. This day is known as the "Patch Change Day." For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time.

Use the Ortho Evra patch exactly as prescribed by your doctor.

Ortho Evra is unlikely to cause an overdose because the patch releases a steady amount of the hormones. Do not use more than one patch at a time. Serious ill effects have not been reported when large doses of oral contraceptives were accidentally taken by young children. Overdosage may cause nausea and vomiting. Vaginal bleeding may occur in females. In case of overdosage, contact your healthcare professional or pharmacist.

Each beige Ortho Evra patch contains 6.00 mg norelgestromin and 0.75 mg ethinyl estradiol.

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).

Store patches in their protective pouches. Apply to the skin immediately upon removal from the protective pouch.

Do not store in the refrigerator or freezer.

Used patches still contain some active hormones. To help protect the environment and help prevent accidental ingestion by children or pets:

• Fold the sticky sides of the patch together and place it in a sturdy container, preferably with a child-resistant cap or ask your pharmacist for a bottle with a child-resistant cap. Ensure the opening is large enough for a folded patch to go in but small enough that a child's hand cannot enter. If a child-resistant container is unavailable then fold the sticky sides of the patch together and place it in a closable container, such as a sealable bag.
• Throw the container in the trash. Used patches should not be flushed down the toilet.
• Return unused, unneeded, or expired patches to your pharmacist.

WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL