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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 3,300 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 non–hormonal backup contraception is not needed.

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. There is now a new "Patch Change Day" and a new "Day 1."
  • NOTE: You must use backup contraception, such as condoms, spermicide or a diaphragm for the first week of the new cycle because you may not be protected from pregnancy during this time.

...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."
  • NOTE: 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."
  • NOTE: You must use backup contraception, such as condoms, spermicide or a diaphragm for one week because you may not be protected from pregnancy during this time.

...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.

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 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 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, 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. In 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.
  • ORTHO EVRA® should not be used if you smoke cigarettes and are over 35 years old.

The ORTHO EVRA® patch is a thin, beige, plastic patch that sticks to the skin. The sticky part of the patch contains the following hormones: norelgestromin (progestin) and ethinyl estradiol (estrogen). These hormones are absorbed continuously through the skin and into the bloodstream. On average, the amount of estrogen delivered through the skin produces estrogen exposure that is higher than the exposure when taking a birth control pill containing 35 micrograms of estrogen. Each patch is sealed in a pouch that protects it until you are ready to wear it.


IMPORTANT SAFETY INFORMATION

Any woman who considers using the contraceptive patch ORTHO EVRA® should understand the benefits and risks of using this form of birth control. You should discuss the Important Safety Information provided here with your healthcare professional, before you first start using the contraceptive patch ORTHO EVRA® and during your revisits. You should also follow your healthcare professional's advice with regard to regular checkups.

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

  • What are the risks of using hormonal contraceptives including ORTHO EVRA®?
    • Blood clots that cause death or serious disability
    • Heart attacks and strokes; smoking while using ORTHO EVRA® greatly increases the possibility of having a heart attack or stroke
    • Gallbladder disease
    • Benign but dangerous liver tumors
    • Breast and cervical cancer

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, 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

  • 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 breast-feeding
    • 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, 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.

    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 non-prescription medicines, vitamins, herbal and dietary supplements. Especially tell your healthcare professional if you take:

    • barbiturates (for example phenobarbitol)
    • bosentan (Tracleer®)
    • carbamazepine (Tegretol® is one brand of this drug)
    • felbamate
    • griseofulvin (Fulvicin® is one brand of this drug)
    • oxcarbazepine
    • phenytoin (Dilantin® is one brand of this drug)
    • rifampin
    • St. John's wort (a herbal supplement)
    • topiramate (TOPAMAX®)

    These medicines/herbal supplements may make your contraceptive less effective and you may need to use a barrier contraceptive when you take these drugs or products.

    Also, tell your healthcare professional if you take lamotrigine (LAMICTAL®), an anticonvulsant used for epilepsy. This may increase the risk of seizures so your healthcare professional may need to adjust the dose.

    Blood levels of estrogen in ORTHO EVRA® may be increased if you take certain medicines or drink grapefruit juice while using ORTHO EVRA®. Also, taking ORTHO EVRA® with other medicines may make some medicines less effective. You should 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.

    Ask your healthcare professional if you are not sure if any of your medicines are listed above.

  • What are the possible side effects of ORTHO EVRA®?
    • 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. Single replacement patches are available from pharmacies.
    • Irregular vaginal bleeding or spotting. 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 such as change in vision or inability to wear your lenses. If these occur, contact your healthcare professional.
    • Edema (fluid retention) in the ankles or fingers and/or a rise in blood pressure. Contact your healthcare professional if you experience fluid retention.
    • Spotty darkening of the skin (particularly on the face). 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.

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

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 Detailed Patient Labeling from the full Product Information.

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