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How do I start the Patch?
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How do I start the Patch?

ORTHO EVRA® is for skin use only.

Do not cut, damage, or alter the ORTHO EVRA® patch in any way.

How to start using your ORTHO EVRA® patch:

  • If you are not currently using hormonal birth control, you have 2 ways to begin using your ORTHO EVRA® patch. Choose the way that is best for you:

    • First day start: Apply your first ORTHO EVRA® patch during the first 24 hours of your menstrual period.
    • Sunday start: Apply your first ORTHO EVRA® patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first ORTHO EVRA® patch that day, and no back-up birth control is needed.

  • If you are changing from the pill or vaginal contraceptive ring to the ORTHO EVRA® patch:

    • Complete your current pill cycle or vaginal ring cycle. Apply your 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 1 week after taking your last active pill or removing your last vaginal ring, check with your healthcare provider to make sure you are not pregnant. You may still go ahead and start ORTHO EVRA® for contraception.
    • If you apply your ORTHO EVRA® patch more than 1 week after taking your last active pill or removing your last vaginal ring, use a non-hormonal contraceptive method with the ORTHO EVRA® patch for the first 7 days of patch use.

  • If you are starting ORTHO EVRA® after childbirth:

    • If you are not breastfeeding, wait 4 weeks before using ORTHO EVRA® and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only.
    • If you have had sex since your baby was born, wait for your first period, or see your healthcare professional to make sure you are not pregnant before starting ORTHO EVRA®.

  • If you are starting ORTHO EVRA® after a miscarriage or abortion:

    • You may start ORTHO EVRA® immediately after a miscarriage or abortion that occurs in the first 12 weeks (first trimester) of pregnancy. You do not need to use another contraceptive method.
    • If you do not start ORTHO EVRA® within 5 days after a first trimester miscarriage or abortion, use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, while you wait for your period to start. You have 2 ways to begin using your ORTHO EVRA® patch. Choose the way that is best for you:

      • First Day Start–Apply your first ORTHO EVRA® patch during the first 24 hours of your menstrual period.
      • Sunday Start–Apply your first ORTHO EVRA® patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first ORTHO EVRA® patch that day, and no back-up birth control is needed.

    • If you are starting ORTHO EVRA® after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using ORTHO EVRA® and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only.

    • If you have had sex since your miscarriage or abortion, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting ORTHO EVRA®.

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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