The Ortho Evra birth control patch delivers hormones directly through your skin and into your bloodstream. This may help eliminate some of the disadvantages associated with other birth control methods. To achieve maximum contraceptive effectiveness, Ortho Evra birth control patches must be used exactly as directed.
Transdermal Contraceptive System Overview
This system uses a 28-day (four-week) cycle. A new patch is applied each week for three weeks (21 total days).
Week Four is patch-free. Withdrawal bleeding is expected during this time.
Every new patch should be applied on the same day of the week. This day is known as the “Patch Change
Day.” For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a
Monday. Only one ORTHO EVRA patch should be worn at a time.
On the day after Week Four ends a new four-week cycle is started by applying a new ORTHO EVRA patch. Under no
circumstances should there be more than a seven-day patch-free interval between dosing cycles.
If the woman is starting ORTHO EVRA for the first time, she should wait until the
day she begins her menstrual period. Either a First Day start or Sunday start may
be chosen (see below). The day she applies her first patch will be Day 1. Her “Patch
Change Day” will be on this day every week.
• for First Day Start: the patient should apply her first patch during the first 24 hours
of her menstrual period.
If therapy starts after Day 1 of the menstrual cycle, a non-hormonal back-up contraceptive
(such as a condoms, spermicide, or diaphragm) should be used concurrently
for the first 7 consecutive days of the first treatment cycle.
• for Sunday Start: the woman should apply her first patch on the first Sunday after
her menstrual period starts. She must use back-up contraception for the first week
of her first cycle.
If the menstrual period begins on a Sunday, the first patch should be applied on that
day, and no back-up contraception is needed.
Where to apply the patch. The patch should be applied to clean, dry, intact healthy
skin on the buttock, abdomen, upper outer arm or upper torso, in a place where it
won’t be rubbed by tight clothing. ORTHO EVRA should not be placed on skin that
is red, irritated or cut, nor should it be placed on the breasts.
To prevent interference with the adhesive properties of ORTHO EVRA®, no make-up,
creams, lotions, powders or other topical products should be applied to the skin area
where the ORTHO EVRA® patch is or will be placed.
Application of the ORTHO EVRA patch
The foil pouch is opened by tearing it along the edge using the fingers.
The foil pouch should be peeled apart and open flat.
A corner of the patch is grasped firmly and it is gently removed from the foil pouch.
The woman should be instructed to use her fingernail, to lift one corner of the patch
and peel the patch and the plastic liner off the foil liner. Sometimes patches can
stick to the inside of the pouch – the woman should be careful not to accidentally
remove the clear liner as she removes the patch.
Half of the clear protective liner is to be peeled away. (The woman should avoid touching
the sticky surface of the patch).
The sticky surface of the patch is applied to the skin and the other half of the liner is
removed. The woman should press down firmly on the patch with the palm of her
hand for 10 seconds, making sure that the edges stick well. She should check her
patch every day to make sure it is sticking.
The patch is worn for seven days (one week). On the “Patch Change Day”, Day 8, the
used patch is removed and a new one is applied immediately. The used patch still
contains some active hormones – it should be carefully folded 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.
A new patch is applied for Week Two (on Day 8) and again for Week Three (on Day
15), on the usual “Patch Change Day”. Patch changes may occur at any time on the
Change Day. Each new ORTHO EVRA® patch should be applied to a new spot on the
skin to help avoid irritation, although they may be kept within the same anatomic area.
Week Four is patch-free (Day 22 through Day 28), thus completing the four-week
contraceptive cycle. Bleeding is expected to begin during this time.
The next four-week cycle is started by applying a new patch on the usual “Patch
Change Day,” the day after Day 28, no matter when the menstrual period begins or
Under no circumstances should there be more than a seven-day patch-free interval
between patch cycles.
If the ORTHO EVRA patch becomes partially or completely detached and remains detached, insufficient drug
If a patch is partially or completely detached:
• for less than one day (up to 24 hours), the woman should try to reapply it to the same place or replace it
with a new patch immediately. No back-up contraception is needed. The woman’s “Patch Change Day” will
remain the same.
• for more than one day (24 hours or more) OR if the woman is not sure how long the patch has been
detached, SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should stop the current contraceptive
cycle and start a new cycle immediately by applying a new patch. There is now a new “Day 1” and a new
“Patch Change Day.” Back-up contraception, such as condoms, spermicide, or diaphragm, must be used
for the first week of the new cycle.
A patch should not be re-applied if it is 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. If a patch cannot be re-applied,
a new patch should be applied immediately. Supplemental adhesives or wraps should not be used to hold the
ORTHO EVRA® patch in place.
If the woman forgets to change her patch…
• at the start of any patch cycle (Week One /Day 1): SHE MAY NOT BE PROTECTED FROM PREGNANCY.
She should apply the first patch of her new cycle as soon as she remembers. There is now a new “Patch
Change Day” and a new “Day 1.” The woman must use back-up contraception, such as condoms, spermicide,
or diaphragm, for the first week of the new cycle.
• in the middle of the patch cycle (Week Two/Day 8 or Week Three/Day 15),
- for one or two days (up to 48 hours), she should apply a new patch immediately. The next patch should
be applied on the usual “Patch Change Day.” No back-up contraception is needed. (See Figures 3 and 4 in
the Clinical Pharmacology section.)
- for more than two days (48 hours or more), SHE MAY NOT BE PROTECTED FROM PREGNANCY. She
should stop the current contraceptive cycle and start a new four-week cycle immediately by putting on a new
patch. There is now a new “Patch Change Day” and a new “Day 1.” The woman must use back-up
contraception for one week.
• at the end of the patch cycle (Week Four/Day 22),
Week Four (Day 22): If the woman forgets to remove her patch, she should take it off as soon as she
remembers. The next cycle should be started on the usual “Patch Change Day,” which is the day after Day
28. No back-up contraception is needed.
Under no circumstances should there be more than a seven-day patch-free interval between cycles.
If there are more than seven patch-free days, THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY
and back-up contraception, such as condoms, spermicide, or diaphragm, must be used for seven days. As
with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended
drug-free period. If coital exposure has occurred during such an extended patch-free interval, the possibility
of fertilization should be considered.
Change Day Adjustment
If the woman wishes to change her Patch Change Day she should complete her current cycle, removing the
third ORTHO EVRA patch on the correct day. During the patch-free week, she may select an earlier Patch
Day Change by applying a new ORTHO EVRA patch on the desired day. In no case should there be more
than 7 consecutive patch-free days.
Switching from an Oral Contraceptive
Treatment with ORTHO EVRA should begin on the first day of withdrawal bleeding. If there is no withdrawal
bleeding within 5 days of the last active (hormone-containing) tablet, pregnancy must be ruled out. If therapy
starts later than the first day of withdrawal bleeding, a non-hormonal contraceptive should be used
concurrently for 7 days. If more than 7 days elapse after taking the last active oral contraceptive tablet, the
possibility of ovulation and conception should be considered.
Use after Childbirth
Women who elect not to breast-feed should start contraceptive therapy with ORTHO EVRA no sooner than
4 weeks after childbirth. If a woman begins using ORTHO EVRA postpartum, and has not yet had a period,
the possibility of ovulation and conception occurring prior to use of ORTHO EVRA should be considered, and
she should be instructed to use an additional method of contraception, such as condoms, spermicide, or
diaphragm, for the first seven days. (See Precautions: Nursing Mothers, and Warnings: Thromboembolic and
Other Vascular Problems.)
Use after Abortion or Miscarriage106
After an abortion or miscarriage that occurs in the first trimester, ORTHO EVRA may be started immediately.
An additional method of contraception is not needed if ORTHO EVRA is started immediately. If use of
ORTHO EVRA is not started within 5 days following a first trimester abortion, the woman should follow the
instructions for a woman starting ORTHO EVRA for the first time. In the meantime she should be advised to
use a non-hormonal contraceptive method. Ovulation may occur within 10 days of an abortion or miscarriage.
ORTHO EVRA should be started no earlier than 4 weeks after a second trimester abortion or miscarriage.
When ORTHO EVRA is used postpartum or postabortion, the increased risk of thromboembolic disease must