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Ortho Evra

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Ortho Evra

PATIENT INFORMATION

ORTHO EVRA
[OR-tho EV-ruh]
(norelgestromin and ethinyl estradiol) Transdermal System

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.

What is ORTHO EVRA?

ORTHO EVRA is a birth control patch. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called norelgestromin.

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 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.

How well does ORTHO EVRA work?

Your chance of getting pregnant depends on how well you follow the directions for using ORTHO EVRA. The better you follow the directions, the less chance you have of getting pregnant.

In clinical studies, 1 to 2 out of 100 women got pregnant during the first year that they used ORTHO EVRA.

ORTHO EVRA may not be as effective in women weighing more than 198 lbs. (90 kg). If you weigh more than 198 lbs. (90 kg), talk to your healthcare provider about which method of birth control is right for you.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Chart showing the chance of getting pregnant -  Illustration

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

What should I tell my healthcare provider before using ORTHO EVRA?

Before you use ORTHO EVRA tell your healthcare provider:

  • 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 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.

Tell your healthcare provider 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, and topiramate)
  • aprepitant
  • barbiturates
  • bosentan
  • griseofulvin
  • certain combinations of HIV medicines (nelfinavir, ritonavir, ritonavirboosted 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, and 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 provider may need to adjust the dose of lamotrigine.

Women on thyroid replacement therapy may need increased 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.

How should I use ORTHO EVRA?

  • For detailed instructions, see the step-by-step instructions for using ORTHO EVRA at the end of this Patient Information.
  • Use ORTHO EVRA exactly as your healthcare provider tells you to use it.
  • Wear 1 ORTHO EVRA patch at a time. Make sure you remove your old ORTHO EVRA patch before applying your new ORTHO EVRA patch.
  • Do not skip using any ORTHO EVRA patches, even if you do not have sex often.
  • ORTHO EVRA is applied in a 4-week cycle.
    • Apply your ORTHO EVRA patch 1 time each week for 3 weeks (21 total days).
    • Apply each new ORTHO EVRA patch on the same day of the week. This day will be your “Patch Change Day.” For example, if you apply your first ORTHO EVRA patch on a Monday, all of your ORTHO EVRA patches should be applied on a Monday.
    • Do not apply your ORTHO EVRA patch during Week 4. Make sure you remove your old ORTHO EVRA patch. This is your patch-free week. Your menstrual period should start during your patch-free week.
    • Begin a new 4 week cycle by applying a new ORTHO EVRA patch on the day after Week 4 ends. Repeat the cycle of 3 weekly applications followed by a patch-free week.

ORTHO EVRA application calender - Illustration

  • Your ORTHO EVRA patch should never be off for more than 7 days in a row. If your ORTHO EVRA patch is off for more than 7 days in a row and you have sex during this time, you could become pregnant.
  • If you miss a period you might be pregnant. Some women miss their periods or have light periods on hormonal birth control methods even when they are not pregnant. Call your healthcare provider if you miss 1 period and have not used your ORTHO EVRA patch every day or you miss 2 periods in a row.

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 (see following graph), 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 OTHRO EVRA have a higher risk of getting a blood clot. Talk with your healthcare provider 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:

To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use hormonal birth control are followed for one year, between 1 and 5 of these women will develop a blood clot. The figure below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use hormonal birth control, for women who use hormonal birth control, for pregnant women, and for women in the first 12 weeks after delivering a baby.

Likelihood of Developing a Serious Blood Clot (Venous Thromboembolism [VTE])

Likelihood of Developing a Serious Blood Clot -  Illustration

*CHC=combination hormonal contraception
**Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy duration is nine months, the rate is 7 to 27 per 10,000 WY.

Call your healthcare provider 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

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, affect 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 provider.

Less common side effects are:

  • acne
  • less sexual desire
  • bloating or fluid retention
  • blotchy darkening of your skin, especially your face
  • high blood sugar, especially in women with diabetes
  • high fat (cholesterol, triglycerides) levels in the blood
  • depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
  • problems tolerating contact lenses
  • weight gain

Tell your healthcare provider 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 provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store and throw away used ORTHO EVRA patches?

  • Store at room temperature between 59°F to 86°F (15°C to 30°C).
  • Do not store ORTHO EVRA patches outside of their pouches. Apply immediately upon removal from the protective pouch.
  • Do not store in the refrigerator or freezer.
  • Used ORTHO EVRA patches still contain some active hormones. To throw away the ORTHO EVRA patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Do not flush used ORTHO EVRA patches down the toilet.
  • Return unused, unneeded, or expired patches to your pharmacist.

Keep ORTHO EVRA and all medicines out of the reach of children.

General information about the safe and effective use of ORTHO EVRA

Medicines are sometimes prescribed for purposes other than those listed in Patient Information. Do not use ORTHO EVRA for a condition for which it was not prescribed. Do not give ORTHO EVRA to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about ORTHO EVRA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ORTHO EVRA that is written for health professionals.

For more information, go to www.orthoevra.com or call 1-800-JANSSEN (1-800-526-7736).

What are the ingredients in ORTHO EVRA?

Active ingredient: norelgestromin and ethinyl estradiol

Inactive ingredient: polyethylene, polyester, polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate, polyethylene terephthalate (PET) film, and polydimethylsiloxane coating.

Do hormonal birth control methods cause cancer?

Hormonal birth control methods do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use hormonal birth control methods because some breast cancers are sensitive to hormones.

Women who use hormonal birth control methods may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

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. Unplanned bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Unplanned bleeding occurs most often during the first few months of ORTHO EVRA use, but may also occur after you have been using the patch for some time. 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 provider.

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 provider because you may be pregnant. Stop taking ORTHO EVRA if you are pregnant.

What if I want to become pregnant?

You may stop using ORTHO EVRA whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop using the patch.

INSTRUCTIONS FOR USE

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:

Figure A

ORTHO EVRA patch - Illustration

  • 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 provider 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.

Figure B is a picture of the ORTHO EVRA patch.

Figure B

ORTHO EVRA patch - Illustration

Step 1. Choose a place on your body for your ORTHO EVRA patch

Application sites - Illustration

  • The ORTHO EVRA patch may be placed on your upper outer arm, abdomen, buttock or back in a place where it will not be rubbed by tight clothing. Avoid the waistline because clothing and belts may cause your patch to be rubbed off.
  • Do not apply the patch to your breasts.
  • Apply the ORTHO EVRA patch only to skin that is clean, dry, and free of any powder, make-up, cream, oil, or lotion.
  • Do not apply the ORTHO EVRA patch to cut or irritated skin, or in the same location as the previous ORTHO EVRA patch.

Step 2: Apply your ORTHO EVRA patch

  • Tear open the pouch at the top edge. Peel open the foil pouch that contains the ORTHO EVRA patch and its clear plastic cover. Gently remove the ORTHO EVRA patch and its plastic cover together from the pouch, being careful not to separate the patch from the clear plastic cover.

Tear open the pouch - Illustration

  • Using a fingernail, peel away half of the clear plastic. Avoid touching the sticky surface with your fingers.

Peel away half of the clear plastic - Illustration

  • Apply the sticky side of the ORTHO EVRA patch to clean, dry skin. Remove the other half of the clear plastic and apply the entire patch to your skin.

Apply the sticky side - Illustration

  • Press firmly on the ORTHO EVRA patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin.
  • Run your fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the ORTHO EVRA patch.
  • Check your ORTHO EVRA patch every day to make sure all edges are sticking correctly.

Smooth out any “wrinkles” - Illustration

Step 3: Throwing away your ORTHO EVRA patch

    • To throw away the ORTHO EVRA patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash.
    • Used ORTHO EVRA patches should not be flushed in the toilet.

Important notes:

    • Your ORTHO EVRA patch must stick securely to your skin to work properly.
    • Do not try to reapply an ORTHO EVRA patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it. Do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing.
  • If your ORTHO EVRA patch edge lifts up:
    • Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. Run your fingers over the entire surface area to smooth out any “wrinkles” around the edges of the ORTHO EVRA patch.
    • If your ORTHO EVRA patch does not stick completely, remove it and apply a replacement ORTHO EVRA patch.
    • Do not tape or wrap the ORTHO EVRA patch to your skin or reapply an ORTHO EVRA patch that is partially stuck to clothing.
  • If your ORTHO EVRA patch has been off or partially off:
    • For less than 1 Day, try to reapply it. If the ORTHO EVRA patch does not stick completely, apply a new ORTHO EVRA patch immediately. No back-up contraception is needed and your “Patch Change Day” will stay the same.
    • For more than 1 Day or if you are not sure for how long, you could become pregnant. To reduce this chance, apply a new ORTHO EVRA patch and start a new 4 week cycle. You will now have a new “Patch Change Day.” Use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first week of your new 4 week ORTHO EVRA cycle.
    • Talk to your healthcare provider about a replacement ORTHO EVRA patch prescription so you will always have an extra ORTHO EVRA patch available if needed.
  • If you want to move your “Patch Change Day” to a different day of the week, finish your current cycle. Remove your third ORTHO EVRA patch on the correct day.
    • During week 4, the “Patch Free Week” (Day 22 through Day 28), you may choose an earlier “Patch Change Day” by applying a new patch on the day you prefer. You now have a new Day 1 and a new “Patch Change Day.”
  • If your ORTHO EVRA patch becomes uncomfortable or your application site is red, painful or swollen, change your ORTHO EVRA patch. Remove your ORTHO EVRA patch and apply a new patch to a new location until your next “Patch Change Day.”
  • If you forget to change or remove your ORTHO EVRA patch:
    • At the start of any patch cycle (Week 1, Day 1):
      • You could become pregnant. You must use a back-up contraception method for 7 days. Apply the first ORTHO EVRA patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1.
    • In the middle of your patch cycle (Week 2 or Week 3):
      • If you forget to change your ORTHO EVRA patch for 1 or 2 days, apply a new ORTHO EVRA patch as soon as you remember. Apply your next patch on your normal “Patch Change Day.” No back-up contraception method is needed.
      • If you forget to change your ORTHO EVRA patch for more than 2 days, you could become pregnant. Start a new 4 week cycle as soon as you remember by putting on a new ORTHO EVRA patch. You now have a different “Patch Change Day” and a new Day 1. You must use a back-up contraception method for the first 7 days of your new cycle.
    • At the end of your patch cycle (Week 4):
    • If you forget to remove your ORTHO EVRA patch, take it off as soon as you remember. Start your next cycle on your normal “Patch Change Day,” the day after Day 28. No back-up contraception method is needed.
  • If you forget to apply your ORTHO EVRA patch at the start of your next patch cycle, you could become pregnant. Apply the first ORTHO EVRA patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1. Use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first 7 days of your new 4 week ORTHO EVRA cycle.
  • If you have trouble remembering to change your ORTHO EVRA patch, talk to your healthcare provider about how to make patch changing easier or about using another method of contraception.
  • If you are not sure how to use your ORTHO EVRA patch:
    • Use a back-up contraception method such as a condom and spermicide or diaphragm and spermicide anytime you have sex. Make sure to have 1 of these non-hormonal contraception methods ready at all times.
    • Talk to your healthcare provider for instructions on using your ORTHO EVRA patch.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

ORTHO EVRA®
(norelgestromin/ethinyl estradiol transdermal system)

Instructions for Ortho Evra®Patch Application

Please read the FDA-approved patient labeling (Patient Information) provided in this package for additional important information about this product.

HOW TO START USING YOUR ORTHO EVRA®PATCH FOR THE FIRST TIME

You have two options for starting the patch. Choose which option is right for you:

  • First Day Start–Apply your first patch during the first 24 hours of your menstrual period.
  • Sunday Start–Wait until the first Sunday after your menstrual period begins. With this option, a non-hormonal backup method of birth control, such as a condom or diaphragm and spermicide, is needed for the first 7 days of the first cycle only. If your period starts on a Sunday, the first patch should be applied that day, and no backup contraception is 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 non-hormonal method of birth control should be used at the same time as the patch for the first 7 days of patch use.

CHOOSE A PLACE ON YOUR BODY TO PUT THE PATCH

Choose application site - Illustration

  • The patch may be placed on your upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing. For example, do not place it under the waistband of clothing.
  • Do not put the patch on your breasts, on cut or irritated skin, or on the same location as the previous patch.

Before you apply the patch:

  • Make sure your skin is clean and dry.
  • Do not use lotions, creams, oils, powders, or make-up at the patch site. It may cause the patch to fail to stick properly or to become loose.

HOW TO APPLY THE PATCH

  • Tear open the pouch at the top edge. Peel open the foil pouch that contains the patch and its clear plastic cover. Gently remove the patch and its plastic cover together from the pouch, being careful not to separate the patch from the clear plastic cover.

Tear open the pouch - Illustration

  • Using a fingernail, peel away half of the clear plastic. Avoid touching the sticky surface with your fingers.

Peel away half of the clear plastic - Illustration

  • Apply the sticky side of the patch on the skin you have cleaned and dried. Remove the other half of the clear plastic and attach the entire patch to your skin.

Apply the sticky side - Illustration

  • Press firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch adheres to your skin.
  • Run your fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the patch.
  • Check your patch every day to make sure all edges are sticking correctly.

smooth out any “wrinkles” - Illustration

Never cut, damage or alter the patch in any way.

Refer to the FDA-approved patient labeling (Patient Information) provided within this package for complete instructions.

WHEN DO I CHANGE MY ORTHO EVRA®PATCH?

  • The patch works for seven days (one week). Apply a new patch on the same day each week (your Patch Change Day) for 3 weeks in a row. Make sure you have removed your old patch prior to applying the new patch.
  • During week 4, DO NOT wear a patch. Make sure you removed your old patch. (Your period should begin during this week.)
  • Following week 4, repeat the cycle of three weekly applications followed by a patch-free week.

Please see the FDA-approved patient labeling (Patient Information) for important information about what to do if you forget to change your patch and how to dispose of used patches.

ORTHO EVRA application calender - Illustration

WHAT IF MY PATCH BECOMES LOOSE OR FALLS OFF?

The patch must stick securely to your skin to work properly.

If a patch edge lifts up:

  • Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch adheres to your skin. Run your fingers over the entire surface area to smooth out any “wrinkles” around the edges of the patch.
  • If your patch does not stick completely, remove it and apply a replacement patch. (Ask your healthcare professional for a replacement patch prescription so you always have an extra patch available.)
  • Do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing.

If your patch has been off or partially off:

  • For less than 1 Day, try to reapply it. If the patch does not adhere completely, apply a new patch immediately. (No backup contraception is needed and your Patch Change Day will stay the same.)
  • For more than 1 Day or if you are not sure for how long, you could become pregnant. To reduce this risk, apply a new patch and start a new 4-week cycle. You will now have a new Patch Change Day and MUST USE NON-HORMONAL BACKUP CONTRACEPTION (such as a condom or diaphragm and spermicide) for the first week of your new cycle.

HOW TO PURCHASE A REPLACEMENT PATCH

You can get a replacement patch at the pharmacy where you filled your prescription. You will need a replacement patch prescription from your healthcare professional.

If you have any questions about the extra patch or reimbursement for it, or would like to speak with an ORTHO EVRA®Customer Service Representative, please call 1-800-526-7736 or visit us at www.orthoevra.com.

Please see the FDA-approved patient labeling (Patient Information) section of the full Prescribing Information within this package.

Special Precautions for Storage

Store at room temperature, between 59 to 86°F (15 to 30°C).

Store patches in their protective pouches. Apply immediately upon removal from the protective pouch.

Do not store in the refrigerator or freezer.

Last reviewed on RxList: 7/12/2013
This monograph has been modified to include the generic and brand name in many instances.

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