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Top 5 Questions about ORTHO EVRA
1. Where can I wear ORTHO EVRA?
2. Are there any risks associated with using ORTHO EVRA?
3. What should I do if a patch seems loose, partially lifts off of my skin or falls off?
4. Can I wear ORTHO EVRA in the shower or while swimming or exercising?
5. How do I apply the birth control patch?
Other important topics
New important labeling information
What is ORTHO EVRA?
How the ORTHO EVRA birth control patch works
Using ORTHO EVRA
Getting started with ORTHO EVRA
Top 5 Questions
1 Where can I wear ORTHO EVRA?
You can wear ORTHO EVRA on 1 of 4 areas of the body: upper outer arm, upper
torso (front and back, excluding the breasts), abdomen, or buttock. The birth
control patch should not be worn on any other areas of the body.
To ensure the effectiveness of ORTHO EVRA, do not place the birth control patch
on areas of your skin where makeup, lotions, creams, powders, or other products
are or will be applied. In addition, do not place
ORTHO EVRA on skin that is red,
irritated, or cut.
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2 Are there any risks associated with ORTHO EVRA?
Serious as well as minor side effects have been reported with the use of the Patch. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.
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. 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 with your healthcare professional whether ORTHO EVRA is a good method of contraception for you. The Patch does not protect against HIV or sexually transmitted diseases.
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3 What should I do if a patch seems loose, partially lifts off of my skin, or falls off?
Do not try to reapply a birth control patch if it is no longer sticky; if it
has been stuck to itself or another surface; if it has other material stuck to
it; or if it has become loose or has fallen off before.
For less than 24&nbps;hours: Try to reapply your patch or apply a new patch
immediately. No backup contraception is needed and your "Patch Change
Day" will remain the same.
For more than 24 hours, or if you are not sure for how long: Start a new
4-week cycle immediately by applying a new patch. You now have a new Day 1
and a new "Patch Change Day". You must use backup contraception,
such as a condom, spermicide or a diaphragm, for the first week of your new cycle
because you may become pregnant during this time.
Re-apply the Patch by following these instructions:
- Press down firmly on the Patch with the palm of your hand for 10 seconds,
making sure that the edges stick well. Then run your fingers around the edge of
the Patch. Do not use tapes or wraps to keep the birth control patch in place.
- If the birth control Patch does not stick well, remove it and then apply
a replacement birth control Patch. This Patch should be replaced on the original
"Patch Change Day." Single replacement patches are available through
your pharmacist.
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4 Can I wear ORTHO EVRA in the shower or while swimming or exercising?
Yes. The Patch adheres well to the skin, allowing you to perform your daily activities
such as bathing, showering, swimming, and exercising without interruption. If
the sticky surface of the Patch becomes wet, discard it and apply a new patch.
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5 How do I apply the birth control patch?
Follow these simple steps to put on the Patch:
- Open the foil pouch by tearing it along the top edge and one side edge. Peel
the foil pouch apart and open it flat.
- The Patch is covered by a layer of clear plastic. Remove the Patch and
the plastic together from the foil pouch.
- Using your fingernail, lift one corner of the Patch and peel it and
the plastic off the foil liner. Sometimes patches can stick to the inside of the
pouch—be careful not to accidentally remove the clear liner as you remove the
Patch.
- Peel away half of the clear plastic. (Avoid touching the sticky surface of
the Patch with your fingers.)
- Apply the sticky side of the Patch to clean and dry skin, then remove the other
half of the clear plastic.
- Press firmly on the Patch with the palm of your hand for
10 seconds, making
sure the edges stick well. Run your fingers around the edge of the Patch to make
sure it is sticking properly.
- Check your patch every day to make sure all edges are sticking
- Do not cut, damage or alter the ORTHO EVRA patch in any way.
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What is ORTHO EVRA?
6 What is ORTHO EVRA?
ORTHO EVRA, the first and only once-a-week birth control patch, offers the same
efficacy as the Pill and is more convenient to use. To prevent pregnancy, the Patch
is worn on the skin for one week and replaced on the same day of the week for
3 consecutive weeks, with the fourth week "patch-free."
7 What does ORTHO EVRA look like?
ORTHO EVRA is an incredibly smooth and thin beige patch that measures 1 3/4 inches
on each of its 4 sides.
8 Is ORTHO EVRA available in different colors?
Currently, ORTHO EVRA is only available in beige. Beige was selected because
it best maintained its appearance over the 7-day wear period.
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How the ORTHO EVRA birth control patch works
9 How does ORTHO EVRA help to prevent pregnancy?
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.
10 How does the medicine get into my system?
The transdermal—or "through the skin"—weekly birth control patch prevents
pregnancy by delivering continuous levels of the hormones norelgestromin and ethinyl
estradiol (progestin and estrogen, respectively) through the skin and into the
bloodstream.
Click here to watch how the Patch works.
11 Has the Patch been tested?
Yes. In clinical trials more than 70,000 birth control patches have been tested
worldwide in more than 3,300 women.
12 Are there any side affects associated with ORTHO EVRA?
In clinical trials, the most frequent adverse events leading to discontinuation
in 1.0% to 2.4% of women included nausea and/or vomiting, application site reaction,
breast symptoms, headache, and emotional lability.
Serious as well as minor side effects have been reported with the use of the Patch. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.
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. 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 with your healthcare professional whether ORTHO EVRA is a good method of contraception for you. The Patch does not protect against HIV or sexually transmitted diseases.
13 How long do I need to wear the birth control patch before I am protected from pregnancy?
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.
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Using ORTHO EVRA
14 How do I start the ORTHO EVRA birth control patch?
You may choose a "First Day Start" or a "Sunday Start" as
defined below:
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.
15 How do I use the ORTHO EVRA birth control patch?
Apply a new patch on the same day of the week for 3 consecutive weeks, for a total
of 21 days. You should not apply a patch during the fourth "patch-free"
week, which is when your menstrual period should start.
After week 4 ends, begin a new 4-week cycle by applying a new birth control
patch on your normal "Patch Change Day"—no matter when your period begins
or ends.
Here are a few things to remember when using the Patch:
- Every new patch should be applied on the same day of each week, called
the "Patch Change Day." For example, if you apply your first patch on
a Monday, all of your patches should be applied on a Monday.
- The birth control patch may be worn on the upper outer arm, upper torso
(front and back, excluding the breasts), abdomen, or buttock.
- Wear only 1 birth control patch at a time.
- To avoid irritation, do not apply the new patch to the same exact place
on your skin.
- Under no circumstances should there be more than a 7-day, patch-free
interval between patch cycles.
16 How does the Patch stay on?
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 percent of birth control patches had to be replaced
because of complete detachment, and less than 3 percent 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.
17 On the "Patch Change Day," can I place it on a different area
of the body?
Yes. The new patch can be placed on 1 of the 4 recommended areas: upper outer
arm, upper torso (front and back, excluding the breasts), abdomen, or buttock.
18 Can I change the location of ORTHO EVRA in the middle of the
week?
It is not recommended that you move your birth control patch to a new location
in the middle of the week. The Patch may not stick as well if you attempt to change
its location.
19 How do I change my "Patch Change Day?
"If you wish to move your "Patch Change Day" to a different day
of the week:
- Finish your current cycle, removing your third ORTHO EVRA patch on the
correct day.
- During week four, the "patch-free" week, you may choose a new
"Patch Change Day" by applying a new patch on the day you prefer. Remember
that you should never have the birth control patch off for more than 7 days in
a row.
- You now have a new Day 1 and a new "Patch Change Day."
20 What if I forget to change the Patch?
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 Two/Day 8 or Week Three/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 4-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 Four/Day 22), Week Four (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 7 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.
21 Can I decorate or cut my Patch?
No. To ensure the effectiveness of ORTHO EVRA, you should not write on the Patch, cut it, 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.
22 Can lotions (moisturizing lotions, tanning lotions, etc.) affect the
ORTHO EVRA birth control patch?
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 near a patch
you are wearing. These products may cause the Patch to become loose.
23 How do I clean the dirt/dark ring around my Patch?
If a small ring of adhesive is left on your skin when you remove the Patch on
your "Patch Change Day," remove it by rubbing a small amount of baby
oil on the area.
It is not recommended that you clean the edges of the Patch prior to removal on
the "Patch Change Day." Lifting the edges of the Patch may cause it
to become loose or fall off. Using creams, oils, or powders near the Patch also
may cause it to become loose.
24 How do I remove and discard the Patch?
When removing your used patch, simply lift one corner and quickly peel it back.
If a small ring of adhesive is left on your skin, remove it by rubbing a small
amount of baby oil on the area.
The used patch still contains some active hormone. Before safely disposing of
it in the trash, fold the used patch in half so it sticks to itself. Used patches
should not be flushed down the toilet.
25 Are there special instructions for storage?
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.
26 Can a woman with sensitive skin use it?
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."
27 Who should not use ORTHO EVRA?
If you are pregnant, or think you may become pregnant, you should not use the
birth control patch. In addition, you should not use ORTHO EVRA if you have any
of the following conditions:
- History of heart attack, blood clots, or stroke
- Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism),
or eyes
- History of blood clots in the deep veins of your legs
- 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 healthcare professional 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 such as ORTHO
EVRA, Norplant®*, or the birth control pill
- Liver tumor (benign or cancerous)
- Severe high blood pressure
- Diabetes with complications of the kidneys, eyes, nerves or blood vessels
- Headaches with neurological symptoms
- Disease of heart valves
with complications
- Need for a prolonged period of bed rest following major surgery
- An allergic reaction to any of the components of
ORTHO EVRA
Tell your doctor or healthcare professional if you have ever had any of these
conditions. He or she can recommend a non-hormonal method of birth control.
*Norplant is a registered trademark of Wyeth.
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Getting started with ORTHO EVRA
28 How do I switch from birth control pills to ORTHO EVRA?
Simply follow these instructions to switch to ORTHO EVRA from a birth control pill.
- Complete your cycle with your current birth control pill.
- If you do not get your period within 5 days of taking the last active
pill, check with your doctor or healthcare professional to make sure that you
are not pregnant
- Apply the ORTHO EVRA birth control patch within the first 24 hours of
your period.
- If you choose to apply your patch on the Sunday after the first day of
your period ("Sunday Start"), you must use backup contraception,
such as a condom, spermicide or a diaphragm, for the first week of your first
cycle.
29 Does it matter which patch I use from the box?
No. Each patch delivers the same amount of medication each week. Therefore, the
patches can be used in any order. However, a new birth control patch must be applied
on the same day of the week for 3 consecutive weeks. The fourth week is "patch
free" - which is similar to the fourth week of birth control pill use, during
which inactive pills or no pills are taken.
30 Do I only need to wear the birth control patch when I have sex?
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.
31 Will I still get my period when using the ORTHO EVRA birth control patch?
You can expect your menstrual period to begin a few days after removing the third
birth control patch (during the fourth, "patch-free" week).
32 What does ORTHO EVRA cost?
The price of ORTHO EVRA is comparable to today's leading birth control pills.
Please check with your local pharmacist for pricing information.
33 Is ORTHO EVRA available everywhere?
ORTHO EVRA is available by prescription in the United States. To request more
information about ORTHO EVRA, talk to your doctor or healthcare
professional.
34 Will my insurance cover ORTHO EVRA?
ORTHO EVRA is covered by most major managed care formularies, providing access
to millions of women. Please consult your insurance company, which can best provide
you with the most up-to-date coverage information.
35 What should I do if I take other medications?
Certain drugs may interact with the ORTHO EVRA birth control patch and some other
hormonal contraceptives, making them less effective in preventing pregnancy and
possibly causing an increase in breakthrough bleeding. Such drugs include:
- Rifampin
- Drugs for epilepsy, such as barbiturates (eg, phenobarbital) and anticonvulsants,
including topiramate, carbamazepine, phenytoin Certain drugs used in the treatment
of HIV/AIDS
- Certain antibiotics
- Herbal products containing St. John's wort
As with any prescription product, you should tell your doctor or healthcare professional
about any other medications you are taking. You should use a backup contraceptive,
such as condoms, spermicide or a diaphragm, if you are taking a drug that can
make the birth control patch less effective.
36 What if I want to become pregnant?
If you want to become pregnant, the first thing you should do is call your doctor
or healthcare professional about steps you should take to ensure a healthy pregnancy.
He or she can help you decide when to stop taking the ORTHO EVRA birth control
patch.
After you have stopped using the Patch, you may want to postpone conception until
you start having regular periods again. Many healthcare professionals tell women
to wait a few months to conceive, because a pregnancy can be dated more accurately
if the woman has reestablished her natural menstrual cycle after finishing birth
control.
37 How do I get an extra birth control patch?
Extra patches are available by prescription from your doctor or healthcare professional.
If you have any questions about the extra patch, and would like to speak with
an ORTHO EVRA customer service representative, please call 1-800-526-7736.
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