A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ortho-Evra Patient, Information, Instructions - Norelgestromin and Ethinyl Estradiol
Ortho-Evra Patient, Information, Instructions - Norelgestromin and Ethinyl Estradiol
INFORMATION FOR PATIENTS
ORTHO EVRA™ (norelgestromin/ethinyl estradiol transdermal system) ® only
This product is intended to prevent pregnancy. It does not protect against
HIV (AIDS) or other sexually transmitted diseases.
DESCRIPTION
The contraceptive patch ORTHO EVRA™ is a thin, beige,
plastic patch that sticks to the skin. The sticky part of the patch contains
the hormones norelgestromin and ethinyl estradiol, which are absorbed
continuously through the skin and into the bloodstream. Each patch is
sealed in a pouch that protects it until you are ready to wear it.
INTRODUCTION
Any woman who considers using the contraceptive patch
ORTHO EVRA™ should understand the benefits and risks of using this form
of birth control. This leaflet will give you much of the information you
will need to make this decision and will also help you determine if you
are at risk of developing any serious side effects. It will tell you how
to use the contraceptive patch properly so that it will be as effective
as possible. However, this leaflet is not a replacement for a careful
discussion between you and your health care professional. You should discuss
the information provided in this leaflet with him or her, both when you
first start using the contraceptive patch ORTHO EVRA™ and during your
revisits. You should also follow your health care professional's advice
with regard to regular check-ups while you are using the contraceptive
patch.
EFFECTIVENESS OF HORMONAL CONTRACEPTIVE METHODS
Hormonal contraceptives, including ORTHO EVRA™, are used to prevent pregnancy
and are more effective than most other non-surgical methods of birth control.
When ORTHO EVRA™ is used correctly, the chance of becoming pregnant is
approximately 1% (1 pregnancy per 100 women per year of use when used
correctly), which is comparable to that of the pill. The chance of becoming
pregnant increases with incorrect use. Clinical trials suggested that
ORTHO EVRA™ may be less effective in women weighing more than 198 lbs.
(90 kg). If you weigh more than 198 lbs. (90 kg) you should talk to your
health care professional about which method of birth control may be best
for you.
Typical failure rates for other methods of birth control during the first
year of use are as follows: Implant: <1% Injection: <1% IUD: <1-2%
Diaphragm with spermicides: 20% Spermicides alone: 26% Female sterilization:
<1% Male sterilization: <1% Cervical Cap with spermicide: 20 to
40% Condom alone (male): 14% Condom alone (female): 21% Periodic abstinence:
25% No birth control method: 85% Withdrawal: 19%
WHO SHOULD NOT USE ORTHO EVRA™
Hormonal contraceptives include birth control pills,
injectables, implants, the vaginal ring, and the contraceptive patch.
The following information is derived primarily from studies of birth control
pills. The contraceptive patch is expected to be associated with similar
risks:
Cigarette smoking increases the risk of serious cardiovascular
side effects from hormonal contraceptive use. This risk increases with
age and with heavy smoking (15 or more cigarettes per day) and is quite
marked in women over 35 years of age. Women who use hormonal contraceptives,
including ORTHO EVRA™, are strongly advised not to smoke.
Some women should not use the ORTHO EVRA™ contraceptive patch. For example,
you should not use ORTHO EVRA™ if you are pregnant or think you may be
pregnant. You should also not use ORTHO EVRA™ 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
• 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 such
as ORTHO EVRA™, NORPLANT, or the birth control pill •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 period of bed rest following major surgery
• An allergic reaction to any of the components of ORTHO EVRA™
Tell your health care professional if you have ever had any of these
conditions. Your health care professional can recommend a non-hormonal
method of birth control.
OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA™
Talk to your health care professional about using ORTHO EVRA™ if • you
smoke • you are recovering from the birth of a baby • you are recovering
from a second trimester miscarriage or abortion • you are breast feeding
• you weigh 198 pounds or more • you are taking any other medications
Also, tell your health care professional if you have or have had:
•Breast nodules, fibrocystic disease of the breast, an abnormal breast
x-ray or mammogram •A 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
• Scanty or irregular menstrual periods
If you have any of these conditions you should be checked often by your
health care professional if you use the contraceptive patch.
RISKS OF USING HORMONAL CONTRACEPTIVES, INCLUDING ORTHO EVRA™
The following information is derived primarily from studies of birth
control pills. Since ORTHO EVRA™ contains hormones similar to those found
in birth control pills, it is expected to be associated with similar risks:
1. Risk of developing blood clots
Blood clots and blockage of blood vessels that can cause
death or serious disability are some of the most serious side effects
of using hormonal contraceptives, including the ORTHO EVRA™ contraceptive
patch. In particular, a clot in the legs can cause thrombophlebitis, and
a clot that travels to the lungs can cause sudden blocking of the vessel
carrying blood to the lungs. Rarely, clots occur in the blood vessels
of the eye and may cause blindness, double vision, or impaired vision.
If you use ORTHO EVRA™ and need elective surgery, need
to stay in bed for a prolonged illness or injury or have recently delivered
a baby, you may be at risk of developing blood clots. You should consult
your doctor about stopping ORTHO EVRA™ four weeks before surgery and not
using it for two weeks after surgery or during bed rest. You should also
not use ORTHO EVRA™ soon after delivery of a baby. It is advisable to
wait for at least four weeks after delivery if you are not breast- feeding.
If you are breast-feeding, you should wait until you have weaned your
child before using ORTHO EVRA™. (See also the section on Breast Feeding
in General Precautions.)
2. Heart attacks and strokes
Hormonal contraceptives, including ORTHO EVRA™, may increase
the risk of developing strokes (blockage or rupture of blood vessels in
the brain) and angina pectoris and heart attacks (blockage of blood vessels
in the heart). Any of these conditions can cause death or serious disability.
Smoking and the use of hormonal contraceptives including
ORTHO EVRA™ greatly increase the chances of developing and dying of heart
disease. Smoking also greatly increases the possibility of suffering heart
attacks and strokes.
3. Gallbladder disease
Women who use hormonal contraceptives, including ORTHO EVRA™, probably
have a greater risk than nonusers of having gallbladder disease.
4. Liver tumors
In rare cases, combination oral contraceptives can cause
benign but dangerous liver tumors. Since ORTHO EVRA™ contains hormones
similar to those in birth control pills, this association may also exist
with ORTHO EVRA™. These benign liver tumors can rupture and cause fatal
internal bleeding. In addition, some studies report an increased risk
of developing liver cancer. However, liver cancers are rare.
5. Cancer of the reproductive organs and breasts
Various studies give conflicting reports on the relationship
between breast cancer and hormonal contraceptive use. Combination hormonal
contraceptives, including ORTHO EVRA™, may slightly increase your chance
of having breast cancer diagnosed, particularly after using hormonal contraceptives
at a younger age. After you stop using hormonal contraceptives, the chances
of having breast cancer diagnosed begin to go back down. You should have
regular breast examinations by a health care professional and examine
your own breasts monthly. Tell your health care professional if you have
a family history of breast cancer or if you have had breast nodules or
an abnormal mammogram.
Women who currently have or have had breast cancer should not use oral
contraceptives because breast cancer is usually a hormone-sensitive tumor.
Some studies have found an increase in the incidence
of cancer of the cervix in women who use oral contraceptives, although
this finding may be related to factors other than the use of oral contraceptives.
However, there is insufficient evidence to rule out the possibility that
oral contraceptives may cause such cancers.
ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY
All methods of birth control and pregnancy are associated
with a risk of developing certain diseases that may lead to disability
or death. An estimate of the number of deaths associated with different
methods of birth control and pregnancy has been calculated and is shown
in the following table.
ORTHO EVRA™ is expected to be associated with similar risks as oral contraceptives:
Annual Number of Birth-Related or Method-Related Deaths Associated With
Control of Fertility Per 100,000 Nonsterile Women by Fertility Control
Method According to Age
|
|
|
|
|
|
|
|
|
Method of control and outcome
|
15-19
|
20-24
|
25-29
|
30-34
|
35-39
|
40-44
|
|
|
|
|
|
|
|
|
|
No fertility control methods*
|
7.0
|
7.4
|
9.1
|
14.8
|
25.7
|
28.2
|
|
Oral contraceptives
|
|
|
|
|
|
|
|
non-smoker**
|
0.3
|
0.5
|
0.9
|
1.9
|
13.8
|
31.6
|
|
Oral contraceptives
|
|
|
|
|
|
|
|
smoker**
|
2.2
|
3.4
|
6.6
|
13.5
|
51.1
|
117.2
|
|
IUD**
|
0.8
|
0.8
|
1.0
|
1.0
|
11.4
|
1.4
|
|
Condom*
|
1.1
|
1.6
|
0.7
|
0.2
|
0.3
|
0.4
|
|
|
|
|
|
|
|
|
|
Diaphragm/ spermicide*
|
1.9
|
1.2
|
1.2
|
1.3
|
2.2
|
2.8
|
|
Periodic abstinence*
|
2.5
|
1.6
|
1.6
|
1.7
|
2.9
|
3.6
|
|
*Deaths are birth-related
**Deaths are method-related Adapted from H.W. Ory, ref. # 35.
|
In the above table, the risk of death from any birth
control method is less than the risk of childbirth, except for oral contraceptive
users over the age of 35 who smoke and pill users over the age of 40 even
if they do not smoke. It can be seen in the table that for women aged
15 to 39, the risk of death was highest with pregnancy (7-26 deaths per
100,000 women, depending on age). Among pill users who do not smoke, the
risk of death is always lower than that associated with pregnancy for
any age group, although over the age of 40, the risk increases to 32 deaths
per 100,000 women, compared to 28 associated with pregnancy at that age.
However, for pill users who smoke and are over the age of 35, the estimated
number of deaths exceeds those for other methods of birth control. If
a woman is over the age of 40 and smokes, her estimated risk of death
is four times higher (117/100,000 women) than the estimated risk associated
with pregnancy (28/100,000 women) in that age group.
In 1989 an Advisory Committee of the FDA concluded that the benefits
of low-dose hormonal contraceptive use by healthy, non-smoking women over
40 years of age may outweigh the possible risks.
WARNING SIGNALS
If any of these adverse effects occur while you are using ORTHO EVRA™,
call your doctor immediately:
• Sharp chest pain, coughing of blood, or sudden shortness of breath
(indicating a possible clot in the lung)
• Pain in the calf (indicating a possible clot in the leg)
• Crushing chest pain or tightness in the chest (indicating a possible
heart attack)
•Sudden severe headache or vomiting, dizziness or fainting, disturbances
of vision or speech, weakness, or numbness in an arm or leg (indicating
a possible stroke)
• Sudden partial or complete loss of vision (indicating a possible clot
in the eye)
•Breast lumps (indicating possible breast cancer or fibrocystic disease
of the breast; ask your doctor or health care professional to show you
how to examine your breasts)
•Severe pain or tenderness in the stomach area (indicating a possibly
ruptured liver tumor)
•Severe problems with sleeping, weakness, lack of energy, fatigue, or
change in mood (possibly indicating severe depression)
• Jaundice or a yellowing of the skin or eyeballs accompanied frequently
by fever, fatigue, loss of appetite, dark colored urine, or light colored
bowel movements (indicating possible liver problems)
SIDE EFFECTS OF ORTHO EVRA™
1. Skin irritation
Skin irritation, redness or rash may occur at the site
of application. If this occurs, the patch may be removed and a new patch
may be applied to a new location until the next Change Day. Single replacement
patches are available from pharmacies.
2. Vaginal bleeding
Irregular vaginal bleeding or spotting may occur while
you are using ORTHO EVRA™. Irregular bleeding may vary from slight staining
between menstrual periods to breakthrough bleeding which is a flow much
like a regular period. Irregular bleeding may occur during the first few
months of contraceptive patch use but may also occur after you have been
using the contraceptive patch for some time. Such bleeding may be temporary
and usually does not indicate any serious problems. It is important to
continue using your contraceptive patches on schedule. If the bleeding
occurs in more than a few cycles or lasts for more than a few days, talk
to your health care professional.
3. Problems wearing contact lenses
If you wear contact lenses and notice a change in vision or an inability
to wear your lenses, contact your health care professional.
4. Fluid retention or raised blood pressure
Hormonal contraceptives, including the contraceptive
patch, may cause edema (fluid retention) with swelling of the fingers
or ankles and may raise your blood pressure. If you experience fluid retention,
contact your health care professional.
5. Melasma
A spotty darkening of the skin is possible, particularly of the face.
This may persist after use of hormonal contraceptives is discontinued.
6. Other side effects
The most common side effects of ORTHO EVRA™ include nausea
and vomiting, breast symptoms, headache, menstrual cramps, and abdominal
pain. In addition, change in appetite, nervousness, depression, dizziness,
loss of scalp hair, rash, and vaginal infections may occur.
GENERAL PRECAUTIONS 1. Weight > 198 lbs. (90 kg)
Clinical trials suggest that ORTHO EVRA™ may be less
effective in women weighing more than 198 lbs. (90 kg) compared with its
effectiveness in women with lower body weights. If you weigh more than
198 lbs. (90 kg) you should talk to your health care professional about
which method of birth control may be best for you.
2. Missed periods and use of ORTHO EVRA™ before or during early pregnancy
There may be times when you may not menstruate regularly
during your patch-free week. If you have used ORTHO EVRA™ correctly and
miss one menstrual period, continue using your contraceptive patches for
the next cycle but be sure to inform your health care professional before
doing so. If you have not used ORTHO EVRA™ as instructed and missed a
menstrual period, or if you missed two menstrual periods in a row, you
could be pregnant. Check with your health care professional immediately
to determine whether you are pregnant. Stop using ORTHO EVRA™ if you are
pregnant.
There is no conclusive evidence that hormonal contraceptive
use causes birth defects when taken accidentally during early pregnancy.
Previously, a few studies had reported that oral contraceptives might
be associated with birth defects, but these findings have not been seen
in more recent studies. Nevertheless, hormonal contraceptives, including
ORTHO EVRA™, should not be used during pregnancy. You should check with
your health care professional about risks to your unborn child from any
medication taken during pregnancy.
3. While breast-feeding
If you are breast-feeding, consult your health care professional
before starting ORTHO EVRA™. Hormonal contraceptives are passed on to
the child in the milk. A few adverse effects on the child have been reported,
including yellowing of the skin (jaundice) and breast enlargement. In
addition, combination hormonal contraceptives may decrease the amount
and quality of your milk. If possible, do not use combination hormonal
contraceptives such as ORTHO EVRA™ while breast-feeding. You should use
a barrier method of contraception since breast-feeding provides only partial
protection from becoming pregnant and this partial protection decreases
significantly as you breast-feed for longer periods of time. You should
consider starting ORTHO EVRA™ only after you have weaned your child completely.
4. Laboratory tests
If you are scheduled for any laboratory tests, tell your doctor you are
using ORTHO EVRA™ since certain blood tests may be affected by hormonal
contraceptives.
5. Drug interactions
Certain drugs may interact with hormonal contraceptives,
including ORTHO EVRA™, to make them less effective in preventing pregnancy
or cause an increase in breakthrough bleeding. Such drugs include rifampin,
drugs used for epilepsy such as barbiturates (for example, phenobarbital),
anticonvulsants such as topiramate (TOPAMAX), carbamazepine (Tegretol
is one brand of this drug), phenytoin (Dilantin is one brand of this drug),
phenylbutazone (Butazolidin is one brand), certain drugs used in the treatment
of HIV or AIDS, and possibly certain antibiotics. Tetracycline has been
shown not to interact with ORTHO EVRA™. Pregnancies and breakthrough bleeding
have been reported by users of combined hormonal contraceptives who also
used some form of St. John’s Wort. As with all prescription products,
you should notify your health care professional of any other medications
you are taking. You may need to use a barrier contraceptive when you take
drugs that can make ORTHO EVRA™ less effective.
6. Sexually transmitted diseases
ORTHO EVRA™ is intended to prevent pregnancy. It does
not protect against HIV (AIDS) or other sexually transmitted diseases
such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis
B, and syphilis.
HOW TO USE ORTHO EVRA™
(see full package insert)
Other information…
• Always apply your patch to clean, dry skin. Avoid
skin that is red, irritated or cut. Do not use creams, oils, powder or
makeup on your skin where you will put a patch or near a patch you are
wearing. It may cause the patch to become loose.
• If patch use results in uncomfortable irritation, the patch may be
removed and a new patch may be applied to a new location until the next
Change Day. Only one patch should be worn at a time.
• Some medicines may change the way ORTHO EVRA™ works. If you are taking
any medication, you must talk to your health care professional BEFORE
you use the patch. You may need to use back-up contraception.
• Store at 25°C (77°F).
• Single replacement patches are available through your pharmacist.
• For further information log on to www.orthoevra.com or call
toll free 1 877 EVRA 888 WHEN YOU SWITCH FROM THE PILL TO ORTHO EVRA™:
If you are switching from the pill to ORTHO EVRA™, wait
until you get your menstrual period. If you do not get your period within
five days of taking the last active pill, check with your health care
professional to be sure that you are not pregnant.
IMPORTANT POINTS TO REMEMBER
1. IT IS IMPORTANT TO USE ORTHO EVRA™ exactly as directed
in this leaflet. Incorrect use increases your chances of becoming pregnant.
This includes starting your contraceptive cycle late or missing your scheduled
CHANGE DAYS.
2. You should wear one patch per week for three weeks,
followed by one week off. You should never have the patch off for more
than seven days in a row. If you have the patch off for more than
seven days in a row and you have had sex during this time, YOU COULD BECOME
PREGNANT.
3. IF YOU ARE NOT SURE WHAT TO DO ABOUT MISTAKES WITH PATCH USE:
• Use a BACK-UP METHOD, such as a condom, spermicide, or diaphragm
anytime you have sex.
• Contact your health care professional for instructions.
4. Do not skip patches even if you do not have sex very often.
5. SOME WOMEN HAVE SPOTTING OR LIGHT BLEEDING, BREAST TENDERNESS OR MAY
FEEL SICK TO THEIR STOMACH DURING ORTHO EVRA™ USE. If these symptoms occur,
do not stop using the contraceptive patch. The problem will usually go
away. If it doesn't go away, check with your health care professional.
6. MISTAKES IN USING YOUR PATCHES CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING.
7. If you miss TWO PERIODS IN A ROW contact your health
care professional because you might be pregnant.
8.The amount of drug you get from the ORTHO EVRA™ patch
should not be affected by VOMITING OR DIARRHEA.
9. IF YOU TAKE CERTAIN MEDICINES, ORTHO EVRA™ may not work
as well. Use a non-hormonal back-up method (such as condoms, spermicide,
or diaphragm) until you check with your health care professional.
10. IF YOU WANT 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"
(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. You should never have the patch off for more
than seven days in a row.
11. BE SURE YOU HAVE READY AT ALL TIMES:
•A NON-HORMONAL BIRTH CONTROL method (such as condoms, spermicide,
or diaphragm) to use as a back-up in case of dosing errors.
12. IF YOU HAVE TROUBLE REMEMBERING TO CHANGE YOUR CONTRACEPTIVE
PATCH, talk to your health care professional about how to make patch-changing
easier or about using another method of birth control.
13. Single replacement patches are available through your pharmacist.
14. For Patch replacement, see "How to use ORTHO EVRA™" section.
IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS
LEAFLET, call your health care professional.
PREGNANCY DUE TO ORTHO EVRA™ FAILURE
The incidence of pregnancy from hormonal contraceptive
failure is approximately one percent (i.e., one pregnancy per 100 women
per year) if used correctly. The chance of becoming pregnant increases
with incorrect use. If contraceptive patch failure does occur, the risk
to the fetus is minimal.
PREGNANCY AFTER STOPPING ORTHO EVRA™
There may be some delay in becoming pregnant after you
stop using ORTHO EVRA™, especially if you had irregular menstrual cycles
before you used hormonal contraceptives. It may be best to postpone conception
until you begin menstruation regularly once you have stopped using ORTHO
EVRA™ and want to become pregnant.
There does not appear to be any increase in birth defects in newborn
babies when pregnancy occurs soon after stopping hormonal contraceptives.
OVERDOSAGE
ORTHO EVRA™ is unlikely to cause an overdose because
the patch releases a steady amount of the hormones. Do not use more than
one patch at a time. Serious ill effects have not been reported when large
doses of oral contraceptives were accidentally taken by young children.
Overdosage may cause nausea and vomiting. Vaginal bleeding may occur in
females. In case of overdosage, contact your health care professional
or pharmacist.
OTHER INFORMATION
Your health care professional will take a medical and
family history before prescribing ORTHO EVRA™ and will examine you. The
physical examination may be delayed to another time if you request it
and the health care professional believes that it is a good medical practice
to postpone it. You should be reexamined at least once a year. Be sure
to inform your health care professional if there is a family history of
any of the conditions listed previously in this leaflet. Be sure to keep
all appointments with your health care professional, because this is a
time to determine if there are early signs of side effects of hormonal
contraceptive use.
Do not use the drug for any condition other than the one for which it
was prescribed. This drug has been prescribed specifically for you; do
not give it to others who may want birth control.
If you want more information about ORTHO EVRA™, ask your health care
professional or pharmacist. They have a more technical leaflet called
the Prescribing Information that you may wish to read.
Special Precautions for Storage and Disposal
Store at room temperature.
Store patches in their protective pouches. Apply to the skin immediately
upon removal from the protective pouch.
Do not store in the refrigerator or freezer.
Used patches still contain some active hormones. Fold each patch in half
so that it sticks to itself before throwing it away.
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