INDICATIONS AND USAGE
ORTHO EVRA® is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.
The pharmacokinetic profile for the ORTHO EVRA® transdermal patch is different from that of an oral contraceptive. Healthcare professionals should balance the higher estrogen exposure and the possible increase risk of venous thromboembolism with ORTHO EVRA® against the chance of pregnancy if a contraceptive pill is not taken daily. (See BOLDED WARNING ; WARNINGS; CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives ).
Like oral contraceptives, ORTHO EVRA® is highly effective if used as recommended in this label.
In 3 large clinical trials in North America, Europe and South Africa, 3,330 women (ages 18-45) completed 22,155 cycles of ORTHO EVRA® use, pregnancy rates were approximately 1 per 100 women-years of ORTHO EVRA® use. The racial distribution was 91% Caucasian, 4.9% Black, 1.6% Asian, and 2.4% Other.
With respect to weight, 5 of the 15 pregnancies reported with ORTHO EVRA® use were among women with a baseline body weight ≥198 lbs. (90kg), which constituted <3% of the study population. The greater proportion of pregnancies among women at or above 198 lbs. was statistically significant and suggests that ORTHO EVRA® may be less effective in these women.
Health Care Professionals who consider ORTHO EVRA® for women at or above 198 lbs. should discuss the patient's individual needs in choosing the most appropriate contraceptive option.
Table 4 lists the accidental pregnancy rates for users of various methods of contraception. The efficacy of these contraceptive methods, except sterilization,IUD, and Norplant depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Table 4: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.
|% of Women Experiencing an Unintended Pregnancy within the|
First Year of Use
|% of Women Continuing Use at One Year3|
|Method||Typical Use1||Perfect Use2|
|Hatcher et al, 1998, Ref. # 1.|
| Ovulation Method||3|
| Parous Women||40||26||42|
| Nulliparous Women||20||9||56|
| Parous Women||40||20||42|
| Nulliparous Women||20||9||56|
| Female (Reality®)||21||5||56|
| Progestin Only||0.5|
| Progesterone T||2.0||1.5||81|
| Copper T380A||0.8||0.6||78|
| LNG 20||0.1||0.1||81|
|Norplant® and Norplant-2®||0.05||0.05||88|
Emergency Contraceptive Pills
Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method
LAM is highly effective, temporary method of contraception.10
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
- 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
- 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
- 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
- 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
- 5 Foams, creams, gels, vaginal suppositories, and vaginal film.
- 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
- 7 With spermicidal cream or jelly.
- 8 Without spermicides.
- 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).
- 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.
ORTHO EVRA® has not been studied for and is not indicated for use in emergency contraception.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, ORTHO EVRA® must be used exactly as directed.
Complete instructions to facilitate patient counseling on proper system usage may be found in the Detailed Patient Labeling.
Transdermal Contraceptive System Overview
ORTHO EVRA® is a combination transdermal contraceptive that contains 6.00 mg norelgestromin (NGMN) and 0.75mg ethinyl estradiol (EE). Systemic exposures (as measured by AUC and Css) of NGMN and EE during use of ORTHO EVRA® are higher and peak concentrations (Cmax) are lower than those produced by an oral contraceptive containing norgestimate 250 µg / EE 35 µg. (See BOLDED WARNING; CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives ).
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 patch should be worn at a time.
The ORTHO EVRA® patch should not be cut, damaged or altered in any way. If the ORTHO EVRA® patch is cut, damaged or altered in size, contraceptive efficacy may be impaired.
On the day after Week Four ends a new four-week cycle is started by applying a new 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. |
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 First Day Start: the patient should apply her first patch during the first 24 hours of her menstrual period.
If the menstrual period begins on a Sunday, the first patch should be applied on that day, and no back-up contraception is needed.
- 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.
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. Used patches should not be flushed down the toilet. For disposal directions, see HOW SUPPLIED: Special Precautions for Storage and Disposal.|
|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 ends.
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 delivery occurs.
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 end of the patch cycle (Week Four/Day 22),
- 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.
- –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.
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 be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease . See PRECAUTIONS for "Nursing Mothers" .)
Breakthrough Bleeding or Spotting
In the event of breakthrough bleeding or spotting (bleeding that occurs on the days that ORTHO EVRA® is worn), treatment should be continued. If breakthrough bleeding persists longer than a few cycles, a cause other than ORTHO EVRA® should be considered.
In the event of no withdrawal bleeding (bleeding that should occur during the patch-free week), treatment should be resumed on the next scheduled Change Day. If ORTHO EVRA® has been used correctly, the absence of withdrawal bleeding is not necessarily an indication of pregnancy. Nevertheless, the possibility of pregnancy should be considered, especially if absence of withdrawal bleeding occurs in 2 consecutive cycles. ORTHO EVRA® should be discontinued if pregnancy is confirmed.
In Case of Vomiting or Diarrhea
Given the nature of transdermal application, dose delivery should be unaffected by vomiting.
In Case of Skin Irritation
If patch use results in uncomfortable irritation, the patch may be removed and a new patch may be applied to a different location until the next Change Day. Only one patch should be worn at a time.
ADDITIONAL INSTRUCTIONS FOR DOSING
Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing hormonal contraceptives. In case of breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should considered. In case of undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another method of contraception may solve the problem.
Use of Hormonal Contraceptives in the Event of a Missed Menstrual Period:
- If the woman has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Hormonal contraceptive use should be discontinued if pregnancy is confirmed.
- If the woman has adhered to the prescribed regimen and misses one period, she should continue using her contraceptive patches.
- If the woman has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. ORTHO EVRA® use should be discontinued if pregnancy is confirmed.