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How it works
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How it works

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1

ORTHO EVRA® helps prevent pregnancy the same way birth control pills do: by preventing ovulation, which means that the ovary does not release an egg to be fertilized; by thickening the cervical mucus, which makes it more difficult for sperm to enter the uterus; and by changing the endometrium to reduce the chance of implantation. Read more on how the Patch works.

2

The transdermal, or "through the skin", weekly birth control patch prevents pregnancy by delivering continuous levels of 2 hormones (progestin and estrogen, respectively) through the skin and into the bloodstream. It is important to know that you will be exposed to about 60% more estrogen if you use ORTHO EVRA® than if you use a typical birth control pill containing 35 micrograms of estrogen.

Hormones from ORTHO EVRA® get into the bloodstream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO 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 ORTHO EVRA® compared to women using birth control pills.You should discuss this possible increased risk with your healthcare professional before using ORTHO EVRA®.

Call your doctor immediately if you experience any of these side effects while you are using the ORTHO EVRA® patch:

  • Sharp chest pain, coughing blood or sudden shortness of breath
  • Pain in the calf
  • Crushing chest pain or tightness in the chest
  • Sudden, severe, headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness or numbness in an arm or leg
  • Sudden partial or complete loss of vision
  • Breast lumps
  • Severe pain or tenderness in the stomach area
  • Severe problems with sleeping, weakness, lack of energy, fatigue or change in mood (possibly indicating severe depression)
  • Jaundice or yellowing of the skin or whites of the eye along with fever, fatigue, loss of appetite, dark-colored urine or light-colored bowel movements

For additional information, please read the IMPORTANT SAFETY INFORMATION section below.

3

Yes. In 3 clinical trials, the Patch was tested worldwide in 3300 women.

4

If the Patch is not applied within the first 24 hours of your period, you must use backup contraception, such as a condom, spermicide, or a diaphragm, for the first week of patch use.

Follow the instructions below to see if or how long you need to use backup contraception, such as a condom, spermicide or a diaphragm.

First Day Start: Apply your first patch during the first 24 hours of your period, which will be considered your "Patch Change Day." If the Patch is not applied within the first 24 hours of your period, you must use backup contraception, such as a condom, spermicide, or a diaphragm, for the first week of patch use.

Sunday Start: Apply your first patch on the first Sunday after your menstrual period starts—this will be your "Patch Change Day." You must use backup contraception, such as a condom, spermicide, or a diaphragm, for the first week of your first cycle. If your period starts on a Sunday, you should start the Patch the same day and nonhormonal backup contraception is not 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 ORTHO EVRA® 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 nonhormonal method of birth control should be used at the same time as the Patch for the first 7 days of patch use.

5

ORTHO EVRA® uses clinically proven patch technology, which includes an adhesive that keeps the Patch on the skin for an entire week.

When applying ORTHO EVRA®, it is important to press down firmly on the Patch with the palm of your hand for 10 seconds, making sure that the edges stick well. ORTHO EVRA® remains attached and effective even when you bathe, swim, exercise or wear it in humid conditions.

In clinical trials, less than 2% of birth control patches had to be replaced because of complete detachment, and less than 3% had to be replaced because of partial detachment. However, your doctor or healthcare professional should provide you with a prescription for an extra patch in the rare event that you need one.

6

If you forget to change your patch...

...at the start of any patch cycle (Week 1, Day 1):

  • Apply the first patch of your new cycle as soon as you remember. You now have a new "Patch Change Day" and a new "Day 1."
  • If you forgot to apply your Patch, YOU COULD BECOME PREGNANT - You must use backup contraception, such as condoms, spermicide or a diaphragm for the first week of the new cycle.

...in the middle of a patch cycle (Week 2/Day 8 or Week 3/Day 15), for 1 or 2 days (up to 48 hours):

  • Apply a new patch immediately.
  • The next patch should be applied on the usual "Patch Change Day."
  • No backup contraception is needed.

...for more than 2 days (48 hours or more):

  • Stop the current cycle and start a new four-week cycle immediately by putting on a new patch. There is now a new "Patch Change Day" and a new "Day 1."
  • If you forgot to apply your Patch, YOU COULD BECOME PREGNANT - You must use backup contraception, such as condoms, spermicide or a diaphragm for one week.

...at the end of the patch cycle (Week 4/Day 22):

  • If you forget to remove your patch, take it off as soon as you remember.
  • Start the next cycle on the usual "Patch Change Day," which is the day after Day 28.
  • NOTE: No backup contraception is needed.

...at the start of your next patch cycle, Day 1 (week one): If you forget to apply your patch, YOU COULD BECOME PREGNANT

  • Apply the first patch of your new cycle as soon as you remember. You now have a new 'Patch Change Day' and new Day 1. You must use backup contraception for the first week of your new cycle.

Under no circumstances should there be more than a 7–day, patch-free interval between cycles. The risk of ovulation increases with each day after the recommended "patch-free" week. If there are more than seven patch-free days, YOU MAY NOT BE PROTECTED FROM PREGNANCY, and backup contraception, such as condoms, spermicide, or a diaphragm, must be used for 1 week.

7

No. To ensure the effectiveness of ORTHO EVRA®, you should not write on the Patch, cut, alter or damage it in any way. Modifying the Patch may affect the amount of medication that is delivered through the skin and into the bloodstream, which may increase your risk of becoming pregnant.

8

Always apply your birth control patch to clean, dry skin. Do not use lotions, creams, oils, powder, or makeup on skin where you are going to put the Patch or on top of or near a Patch you are wearing. These products may cause the Patch to fail to stick or become loose.

9

ORTHO EVRA® birth control patches should be stored in their protective pouches. Store at room temperature (25°C or 77°F) with short variations in other temperatures permitted (to 15-30°C or 59-86°F). Do not store in the refrigerator or freezer.

10

If you have sensitive skin, you may wish to talk to your doctor or healthcare professional prior to using the ORTHO EVRA® birth control patch which may cause some skin irritation. In general, avoid placing ORTHO EVRA® on skin that is red, irritated, or cut. If mild irritation develops during use, the Patch can be removed and a new patch may be applied immediately to a new location until the next "Patch Change Day."

11

No. ORTHO EVRA® must be worn every day for 21 days, whether or not you have sex. Apply a new birth control patch on the same day of the week for 3 consecutive weeks, for a total of 21 days. You will not apply a patch during week 4.

12

You can expect your menstrual period to begin a few days after removing the third birth control patch (during the fourth, "patch-free" week).

Breakthrough bleeding or spotting, which is bleeding that can occur between periods ranging from slight staining to a heavier flow, are side effects that may occur when you use hormonal contraceptives. Irregular bleeding may occur during the first few months of patch use but may also occur after you have been using the Patch for some time. Such bleeding is temporary and usually does not indicate any serious problems. It is important to continue to use your patches on schedule. If the bleeding occurs for more than a few cycles or lasts for more than a few days, talk to your healthcare professional.

What is ORTHO EVRA®?

  • ORTHO EVRA® is a contraceptive patch used for the prevention of pregnancy.
  • ORTHO EVRA® is available by prescription only.
  • ORTHO EVRA® does not protect against HIV (AIDS) or other sexually transmitted diseases.

IMPORTANT SAFETY INFORMATION

Who should not use ORTHO EVRA®?

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. The risk increases with age and the number of cigarettes you smoke.

You should not use ORTHO EVRA® if you are pregnant or think you may be pregnant, or 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
  • 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 bed rest following major surgery
  • An allergic reaction to any of the components of ORTHO EVRA®

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

OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA®

Hormones from ORTHO EVRA® get into the bloodstream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO 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. Like pregnancy, hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35 years. This increased risk is highest when you first start using hormonal birth control. Some studies have reported that women who use ORTHO EVRA® have a higher risk of getting a blood clot. Talk with your healthcare provider about your risk of getting a blood clot before deciding which type of birth control is right for you.


It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

  • Legs (deep vein thrombosis)
  • Lungs (pulmonary embolus)
  • Eyes (loss of eyesight)
  • Heart (heart attack)
  • Brain (stroke)

Call your healthcare professional immediately if any of the side effects listed under “WARNING SIGNALS” occur while you are using ORTHO EVRA® (see below).


What should I tell my healthcare professional before using ORTHO EVRA®?


Tell your healthcare professional if you:

  • Smoke
  • Are recovering from the birth of a baby
  • Are recovering from a second trimester miscarriage or abortion
  • Are breastfeeding
  • Weigh 198 pounds or more
  • Are taking any other medications

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

  • Breast nodules, fibrocystic disease of the breast, or an abnormal breast x-ray or mammogram
  • 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
  • History of scanty or irregular menstrual periods

If you have any of these conditions, you should be checked often by your healthcare professional.


What are the risks of using hormonal contraceptives including ORTHO EVRA®?


Blood Clots: Like pregnancy, hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35 years. This increased risk is highest when you first start using hormonal birth control. Some studies have reported that women who use ORTHO EVRA® have a higher risk of getting a blood clot. Talk with your healthcare provider about your risk of getting a blood clot before deciding which type of birth control is right for you.


It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Call your healthcare professional immediately should any of the adverse side effects listed under “WARNING SIGNALS” occur while you are using ORTHO EVRA® (see below).


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® 4 weeks before surgery and not using it for 2 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 4 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®.


Heart Attack: Hormonal contraceptives, including ORTHO EVRA®, may increase the risk of developing strokes (blockage or rupture of blood vessels in the brain), 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.


Gallbladder Disease: Women who use hormonal contraceptives, including ORTHO EVRA®, probably have a greater risk than nonusers of having gallbladder disease.


Liver Tumors: In rare cases, combination oral contraceptives, including ORTHO EVRA®, can cause benign but dangerous liver tumors. 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.


Cancer of the Reproductive Organs and Breasts: 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.


WARNING SIGNALS

  • Call your doctor immediately if you experience any of these side effects while you are using the ORTHO EVRA® Patch:

    • Sharp chest pain, coughing blood, or sudden shortness of breath
    • Pain in the calf
    • Crushing chest pain or tightness in the chest
    • Sudden, severe, headache or vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg
    • Sudden partial or complete loss of vision
    • Breast lumps
    • Severe pain or tenderness in the stomach area
    • Severe problems with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
    • Jaundice or yellowing of the skin or whites of the eyes along with fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements

  • What are the possible side effects of ORTHO EVRA®?
    • 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.
    • Skin Irritation: Skin irritation at the site of application. If this occurs, remove the Patch and apply a new Patch at a new location until the next Change Day.
    • Vaginal Bleeding: Irregular vaginal bleeding or spotting may occur. If bleeding occurs in more than a few cycles or lasts for more than a few days, call your healthcare professional.
    • 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.
    • Fluid Retention: Edema (fluid retention) in the ankles or fingers and/or a rise in blood pressure may occur. Contact your healthcare professional if you experience fluid retention.
    • Melasma: A spotty darkening of the skin, particularly on the face, is possible. This may persist after you stop using ORTHO EVRA®.
    • Other Side Effects: Weight gain, feeling dizzy, migraine, stomach pain or bloating, vomiting, diarrhea, acne, muscle spasms, vaginal infections, tiredness, painful or heavy periods, more frequent periods, uterine cramps, vaginal discharge, and mood problems such as mood swings, depression, or anxiety.

General Precautions


Weight ≥198 lbs: ORTHO EVRA® may be less effective if you weigh 198 lbs or more. If you weight 198 lbs or more, talk to your healthcare professional about which method of birth control may be best for you.


Missed Periods and Use During Pregnancy: If you have used ORTHO EVRA® correctly and miss one menstrual period, continue using your contraceptive Patches for the next cycle but be sure to inform your healthcare professional before doing so. If you have not used ORTHO EVRA® as instructed and missed a menstrual period, or if you missed two menstrual periods in a row, you could be pregnant. Check with your healthcare professional immediately to determine whether you are pregnant. Stop using ORTHO EVRA® if you are pregnant.


There is no conclusive evidence that hormonal contraceptive use causes birth defects when taken accidentally during early pregnancy. Nevertheless, hormonal contraceptives, including ORTHO EVRA®, should not be used during pregnancy. You should check with your healthcare professional about risks to your unborn child from any medication taken during pregnancy.


Breastfeeding: If you are breastfeeding, consult your healthcare professional before starting ORTHO EVRA®. Hormonal contraceptives are passed on to the child in the breast milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, combination hormonal contraceptives may decrease the amount and quality of your breast milk.


Drug Interactions: Hormonal contraceptives may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician 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. You may need to use a barrier contraceptive when you take medicines or products that can make hormonal contraceptives less effective.


Tell your healthcare professional about all of the medicines you are taking before starting to use the Patch and while you are using the Patch including prescription and nonprescription medicines, vitamins, and herbal and dietary supplements.


Overdosage: Do not use more than one Patch at a time. Overdosage may cause nausea and vomiting. Vaginal bleeding may occur in females. Contact your healthcare professional or pharmacist in case of overdosage.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Please see the full Product Information, including Boxed WARNING.

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