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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. 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®, should be strongly advised not to smoke. ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY Text Continues Below
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. 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 safely disposing of it in the trash. Used patches should not be flushed down the toilet. ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869
© OMP 2001 Revised: May 2003 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. HOW TO USE ORTHO EVRA® Instructions for Use ORTHO EVRA® keeps you from becoming pregnant by transferring hormones to your body through your skin. The patch must stick securely to your skin in order for it to work properly. This method uses a 28 day (four week) cycle. You should apply a new patch each week for three weeks (21 total days). You should not apply a patch during the fourth week. Your menstrual period should start during this patch-free week. Every new patch should be applied on the same day of the week. This day will be your ‘Patch Change Day.’ For example, if you apply your first patch on a Monday, all of your patches should be applied on a Monday. You
should wear only one patch at a time. On the day after week four ends, you should begin a new four week cycle by applying a new patch.
Save these instructions. 1 If this is the first time you are using ORTHO EVRA®, wait until the day you get your menstrual period. The day you apply your first patch will be Day 1. Your ‘Patch Change Day’ will be on this day every week. 2 You may choose a first day start or Sunday start • for First Day start: apply your first patch during the first 24 hours of your menstrual period.
OR
• for Sunday start: apply your first patch on the first Sunday after your menstrual period starts. You must use back-up contraception, such as a condom, spermicide, or diaphragm for the first week of your first cycle.
• The day you apply your first patch will be Day 1. Your ‘Patch Change Day’ will be on this day every week. 3 Choose a place on your body to put the patch. Put the patch on your buttock, abdomen, upper outer arm or upper torso, in a place where it won’t be rubbed by tight clothing. Never put the patch on your breasts. To avoid irritation, apply each new patch to a different place on your skin. 4 Open the foil pouch by tearing it along the top edge and one side edge.
Peel the foil pouch apart and open it flat. 5 You will see that the patch is covered by a layer of clear plastic. It is important to remove the patch and the plastic together from the foil pouch.
Using your fingernail, lift one corner of the patch and peel the patch 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. 6 Peel away half of the clear plastic and be careful not to touch the exposed sticky surface of the patch with your fingers. 7 Apply the sticky side of the patch to the skin you’ve cleaned and dried, 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 finger around the edge of the patch to make sure it is sticking properly. Check your patch every day to make sure all the edges are sticking. 8 Wear the patch for seven days (one week). On your ‘Patch Change Day,’ Day 8, remove the used patch. Apply a new patch immediately. The used patch still contains some medicine – carefully fold it in half so that it sticks to itself before safely disposing of it in the trash. Used patches should not be flushed down the toilet.
Day 1
calendar
First Day Start
or
Sunday Start
CHOOSE ONE OPTION: 9 Apply a new patch for week two (on Day 8) and for week three (on Day 15), on your ‘Patch Change Day.’ To avoid irritation, do not apply the new patch to the same exact place on your skin. 10 Do not wear a patch on week four (Day 22 through Day 28). Your period should start during this week. 11 Begin your next four week cycle by applying a new patch on your normal ‘Patch Change Day,’ the day after Day 28 – no matter when your period begins or ends. If your patch has become loose or has fallen off… • for less than one day, try to re-apply it or apply a new patch immediately. No backup contraception is needed. Your ‘Patch Change Day’ will remain the same. • for more than one day OR if you are not sure for how long, YOU MAY BECOME PREGNANT – Start anew four week cycle immediately by putting on a new patch. You now have a new Day 1 and a new ‘Patch Change Day.’ You must use back-up contraception, such as a condom, spermicide, or diaphragm for the first week of your new cycle. • do not try to re-apply a patch if it’s no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it or if it has previously become loose or fallen off. No tapes or wraps should be used to keep the patch in place. If you cannot re-apply a patch, apply a new patch immediately. If you forget to change your patch… • at the start of any patch cycle, Week one (Day 1): If you forget to apply your patch, YOU COULD BECOME PREGNANT – you must use back-up contraception for one week. Apply the first patch of your new cycle as soon as you remember. You now have a new ‘Patch Change Day’ and new Day 1. • in the middle of your patch cycle, Week two or week three: If you forget to change your patch for one or two days, apply a new patch as soon as you remember. Apply your next patch on your normal ‘Patch Change Day.’ No back-up contraception is
needed. Week two or week three: If you forget to change your patch for more than two days, YOU COULD BECOME PREGNANT – start a new four week cycle as soon as you remember by putting on a new patch. You now have a different ‘Patch Change Day’ and a new Day 1. You must use back-up contraception for the first week of your new cycle. • at the end of your patch cycle, Week four: If you forget to remove your 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 is needed. • at the start of your next patch cycle, Day 1 (week one): If you forget to apply your patch, YOU COULD BECOME PREGNANT – apply the first patch of your new cycle as soon as you remember. You now have a new ‘Patch Change Day’ and new Day 1. You must use back-up contraception for the first week of your new cycle. • you should never have the patch off for more than seven days.
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.
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