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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® may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.
  • ORTHO EVRA® is available by prescription only.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about 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 from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
Women 15 to 44 years of age who use ORTHO EVRA® may have an increased risk of blood clots compared to women who use certain 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, including blood clots.

Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

Who should not use ORTHO EVRA®?

Do not use ORTHO EVRA® if you:

  • smoke and are over 35 years old
  • have or have had blood clots in your arms, legs, eyes, or lungs
  • have an inherited problem that makes your blood clot more than normal
  • have had a stroke
  • have had a heart attack
  • have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart
  • have high blood pressure that medicine cannot control
  • have diabetes with kidney, eye, nerve, or blood vessel damage
  • have had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over age 35
  • have liver disease, including liver tumors
  • have unexplained vaginal bleeding
  • are pregnant or think you may be pregnant. However, ORTHO EVRA® is not known to cause birth defects when used by accident during pregnancy.
  • have had breast cancer or any cancer that is sensitive to female hormones

Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control.

Tell your healthcare professional if you have ever had any of the above conditions. Your healthcare professional may recommend another method of birth control.

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

Before you use ORTHO EVRA®, tell your healthcare professional:

    • about all your medical conditions
    • if you are pregnant or think you are pregnant
    • if you are scheduled for surgery. ORTHO EVRA® may increase your risk of blood clots after surgery. You should stop using your ORTHO EVRA® patch at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery.
    • if you are or will be inactive or immobilized for a long period of time.
    • if you are scheduled for any laboratory tests. Certain blood tests may be affected by hormonal birth control methods.
    • are breastfeeding or plan to breastfeed. Hormonal birth control methods that contain estrogen, like ORTHO EVRA®, may decrease the amount of milk you make. A small amount of hormones from the ORTHO EVRA® patch may pass into your breast milk. Consider another method of birth control until you are ready to stop breastfeeding.
    • if you plan to start or resume ORTHO EVRA® after child birth. The risk of blood clots is increased for a period of time after childbirth. If you are not breastfeeding, wait 4 weeks before using ORTHO EVRA®.

Tell your healthcare professional about all medicines and herbal products that you take.

Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:

    • certain seizure medicines (carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, topiramate)
    • aprepitant
    • barbiturates
    • bosentan
    • griseofulvin
    • certain combinations of HIV medicines (nelfinavir, ritonavir, ritonavir-boosted protease inhibitors)
    • certain non-nucleoside reverse transcriptase inhibitors (nevirapine)
    • rifampin and rifabutin
    • St. John’s wort

Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medicines that may make the ORTHO EVRA® patch less effective.

Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together, including:

    • acetaminophen
    • ascorbic acid
    • medicines that affect how your liver breaks down other medicines (itraconazole, ketoconazole, voriconazole, fluconazole)
    • certain HIV medicines (atazanavir, indinavir)
    • atorvastatin
    • rosuvastatin
    • etravirine

Hormonal birth control methods may interact with lamotrigine, an anti-seizure medicine used for epilepsy. This may increase the risk of seizures, so your healthcare professional may need to adjust the dose of lamotrigine.

If you are taking thyroid replacement therapy, your healthcare professional may need to increase your doses of thyroid hormone.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of ORTHO EVRA®?

See "What is the most important information I should know about ORTHO EVRA®?"

ORTHO EVRA® may cause serious side effects, including:

  • 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. 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 professional about your risk of getting a blood clot before using ORTHO EVRA® or 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 right away if you have:

  • leg pain that will not go away
  • sudden shortness of breath
  • sudden blindness, partial or complete
  • severe pain or pressure in your chest
  • sudden, severe headache unlike your usual headaches
  • weakness or numbness in an arm or leg, or trouble speaking
  • yellowing of the skin or eyeballs

Other serious risks include:

  • liver problems, including liver tumors
  • gallbladder disease
  • high blood pressure

What are the most common side effects of ORTHO EVRA®?

The most common side effects of ORTHO EVRA® are:

    • breast symptoms (discomfort, swelling, or pain)
    • nausea
    • headache
    • skin irritation, redness, pain, swelling, itching, or rash at the patch application site
    • stomach pain
    • pain during menstruation
    • vaginal bleeding and menstrual disorders, such as spotting or bleeding between periods
    • mood, affective and anxiety disorders

Some women have spotting or light bleeding, breast tenderness, or feel sick to their stomach during ORTHO EVRA® use. If these symptoms occur, do not stop using the ORTHO EVRA® patch. The problem will usually go away. If it doesn't go away, check with your healthcare professional.


Tell your healthcare professional about any side effect that bothers you or that does not go away. These are not all the possible side effects of
ORTHO EVRA®. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


What should I know about my period when using ORTHO EVRA® ?

When you use ORTHO EVRA®, you may have bleeding and spotting between periods called unplanned bleeding. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue using the patch on schedule. If the unplanned bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare professional.


What if I miss my scheduled period when using ORTHO EVRA® ?

Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not use all of your patches correctly, or you have symptoms associated with pregnancy, such as morning sickness or unusual breast tenderness, call your healthcare professional because you may be pregnant. Stop taking ORTHO EVRA® if you are pregnant.


How do I use ORTHO EVRA® after childbirth?

If you are not breastfeeding, wait 4 weeks before using ORTHO EVRA®.

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