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.

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.

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

Cigarette Smoking and Serious Cardiovascular Risks

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, hormonal contraceptives, including norelgestromin/ethinyl estradiol, should not be used by women who are over 35 years of age and smoke.

Risk of Venous Thromboembolism

The risk of venous thromboembolism (VTE) among women aged 15–44 who used the norelgestromin/ethinyl estradiol patch compared to women who used oral contraceptives containing 30–35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate was assessed in four U.S. case-control studies using electronic healthcare claims data. The odds ratios ranged from 1.2 to 2.2; one of the studies found a statistically significant increased risk of VTE for current users of norelgestromin/ethinyl estradiol.

Pharmacokinetic Profile of Ethinyl Estradiol

The pharmacokinetic (PK) profile for the norelgestromin/ethinyl estradiol patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations and lower peak concentrations. Area under the time-concentration curve (AUC) and average concentration at steady state for ethinyl estradiol (EE) are approximately 60% higher in women using norelgestromin/ethinyl estradiol compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, peak concentrations for EE are approximately 25% lower in women using norelgestromin/ethinyl estradiol. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using norelgestromin/ethinyl estradiol compared with women using oral contraceptives containing 30–35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism. 

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.

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.

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.

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).

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.

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