"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
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 increased risk of venous thromboembolism (VTE) with ORTHO EVRA®compared to some oral contraceptives against the chance of pregnancy if the patient cannot reliably take a contraceptive pill on a daily basis. (See BOLDED WARNING; WARNINGS; and 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.
Healthcare 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 Year* (4)|
|Method (1)||Typical Use† (2)||Perfect Use‡ (3)|
|Norplant® and Norplant-2®||0.05||0.05||88|
|Hatcher et al, 1998, Ref. # 1. Emergency Contraceptive Pills:Treatment initiated within 72
hours after unprotected intercourse reduces the risk of pregnancy by at least
75%.§Lactational Amenorrhea Method:LAM is a highly effective, temporary
method of contraception.¶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.
* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
† 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.
‡ 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.
§ 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).
¶ 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.
# 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.
Þ Foams, creams, gels, vaginal suppositories, and vaginal film.
β Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
a With spermicidal cream or jelly.
e Without spermicides.
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 0.75 mg 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 mcg / EE 35 mcg. (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.
HOW TO START USING THE ORTHO EVRA® PATCH FOR THE FIRST TIME
The woman has two options for starting the patch and she should choose the option that is right for her:
- First Day Start- The woman should apply her first patch during the first 24 hours of her menstrual period.
- Sunday Start- The woman should apply her first patch on the first Sunday after her menstrual period begins. With this option, a non-hormonal backup method of birth control, such as a condom or diaphragm and spermicide, is needed for the first 7 days of the first cycle only. If her period starts on a Sunday, the first patch should be applied that day, and no backup contraception is needed.
- When Switching From the Pill or Vaginal Contraceptive Ring to the Patch- If the woman is switching from the pill or vaginal contraceptive ring to ORTHO EVRA®, she should complete her current pill cycle or vaginal ring cycle and apply the first ORTHO EVRA® patch on the day she would normally start her next pill or insert her next vaginal ring. If she does not get her period within a week after taking the last active pill or removing the last vaginal ring, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start ORTHO EVRA® for contraception. If the patch is applied more than a week after taking the last active pill or removal of the last vaginal ring, a non-hormonal contraceptive should be used concurrently for the first 7 days of patch use.
CHOOSING A PLACE ON THE BODY TO PUT THE PATCH
- The patch may be placed on the upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing. For example, it should not be placed under the waistband of clothing.
- The patch should not be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.
Before applying the patch:
- The woman should make sure the skin is clean and dry.
- She should not use lotions, creams, oils, powders, or make-up at the patch site. It may cause the patch to fail to stick properly or to become loose.
HOW TO APPLY THE PATCH
The woman should tear open the pouch at the top edge. She should peel open the foil pouch that contains the patch and its clear plastic cover. She should gently remove the patch and its plastic cover together from the pouch, being careful not to separate the patch from the clear plastic cover.
- Using a fingernail, the woman should peel away half of the clear plastic. She should avoid touching the sticky surface with her fingers.
- The woman should apply the sticky side of the patch on the skin she has cleaned and dried. She should then remove the other half of the clear plastic and attach the entire patch to her skin.
- The woman should press firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin.
- She should run her fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the patch.
- The woman should check her patch every day to make sure all edges are sticking correctly.
WHEN TO CHANGE THE ORTHO EVRA®PATCH
- The patch works for seven days (one week). The woman applies a new patch on the same day each week (her Patch Change Day) for 3 weeks in a row. She must make sure she has removed her old patch prior to applying the new patch.
- During week 4, she DOES NOT wear a patch. She must make sure she removes her old patch. (Her period should begin during this week.)
- Following week 4, she repeats the cycle of three weekly applications followed by a patch-free week.
WHAT IF THE PATCH BECOMES LOOSE OR FALLS OFF?
The patch must stick securely to the skin to work properly. If the ORTHO EVRA® patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs. The woman should not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it.
If a patch edge lifts up:
- The woman should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. She should run her fingers over the entire surface area to smooth out any “wrinkles” around the edges of the patch.
- If her patch does not stick completely, she should remove it and apply a replacement patch.
- She should not tape or wrap the patch to her skin or reapply a patch that is partially adhered to clothing.
If the patch has been off or partially off:
- For less than 1 Day, she should try to reapply it. If the patch does not adhere completely, she should apply a new patch immediately. (No backup contraception is needed and her Patch Change Day will stay the same).
- For more than 1 Day or if she is not sure for how long, she may not be protected from pregnancy. To reduce this risk, she should apply a new patch and start a new 4-week cycle. She will now have a new Patch Change Day and MUST USE NON-HORMONAL BACKUP CONTRACEPTION (such as a condom or diaphragm and spermicide) for the first week of her new cycle.
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 a condom or diaphragm and spermicide, for the first week of the new cycle.
- in the middle of the patch cycle (Week Two/Day 8 or Week
- 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.
- 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 a condom or diaphragm and spermicide, 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 pregnancy 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.
Use After Childbirth
Women who elect not to breastfeed 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 a condom or diaphragm and spermicide, 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: 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.
Each beige ORTHO EVRA® patch contains 6.00 mg norelgestromin and 0.75 mg EE.
Each patch surface is heat stamped with ORTHO EVRA® . Each patch is packaged in a protective pouch.
ORTHO EVRA® is available in folding cartons of 1 cycle each (NDC 50458-19215); each cycle contains 3 patches.
ORTHO EVRA® is available for clinic usage in folding cartons of 1 cycle each (NDC 50458-192-24); each cycle contains 3 patches.
ORTHO EVRA® is also available in folding cartons containing a single patch (NDC 50458-192-01), intended for use as a replacement in the event that a patch is inadvertently lost or destroyed.
Special Precautions for Storage and Disposal
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Store patches in their protective pouches. Apply immediately upon removal from the protective pouch.
Do not store in the refrigerator or freezer.
Used patches still contain some active hormones. The sticky sides of the patch should be folded together and the folded patch placed in a sturdy container, preferably with a child-resistant cap, and the container thrown in the trash. Used patches should not be flushed down the toilet.
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Mfd. for: Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560. Mfd. by: Janssen Ortho, LLC Manati, Puerto Rico 00674. Revised August 2012
Last reviewed on RxList: 10/10/2012
This monograph has been modified to include the generic and brand name in many instances.
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