ORTHO EVRA SUMMARY
ORTHO EVRA®
(norelgestromin / ethinyl estradiol TRANSDERMAL SYSTEM)
ORTHO EVRA® is a combination transdermal contraceptive patch with a contact surface area of 20 cm2. It contains 6.00 mg norelgestromin (NGMN) and 0.75 mg ethinyl estradiol (EE). Systemic exposures (as measured by area under the curve [AUC] and steady state concentration [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 ). ORTHO EVRA® is a thin, matrix-type transdermal contraceptive patch consisting of three layers. The backing layer is composed of a beige flexible film consisting of a low-density pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric and lauryl lactate as inactive components. The active components in this layer are the hormones, norelgestromin and ethinyl estradiol. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a polydimethylsiloxane coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is heat-stamped "ORTHO EVRA®".
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 | |
|---|
| (1) | (2) | (3) | (4) |
|---|
| Hatcher et al, 1998, Ref. # 1. |
| Chance4 | 85 | 85 | |
| Spermicides5 | 26 | 6 | 40 |
| Periodic abstinence | 25 | | 63 |
| Calendar | | 9 | |
| Ovulation Method | | 3 | |
| Sympto-Thermal6 | | 2 | |
| Post-Ovulation | | 1 | |
| Cap7 | | | |
| Parous Women | 40 | 26 | 42 |
| Nulliparous Women | 20 | 9 | 56 |
| Sponge | | | |
| Parous Women | 40 | 20 | 42 |
| Nulliparous Women | 20 | 9 | 56 |
| Diaphragm7 | 20 | 6 | 56 |
| Withdrawal | 19 | 4 | |
| Condom8 | | | |
| Female (Reality®) | 21 | 5 | 56 |
| Male | 14 | 3 | 61 |
| Pill | 5 | | 71 |
| Progestin Only | | 0.5 | |
| Combined | | 0.1 | |
| IUD | | | |
| Progesterone T | 2.0 | 1.5 | 81 |
| Copper T380A | 0.8 | 0.6 | 78 |
| LNg 20 | 0.1 | 0.1 | 81 |
| Depo-Provera® | 0.3 | 0.3 | 70 |
| Norplant® and Norplant-2® | 0.05 | 0.05 | 88 |
| Female Sterilization | 0.5 | 0.5 | 100 |
| Male Sterilization | 0.15 | 0.10 | 100 |
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.
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NEWS HIGHLIGHTSMedia Articles Related to Ortho Evra (Norelgestromin / Estradiol Transdermal)
New York Times Examines Debate Over Philippine Bill To Increase Contraception Access
Source: Sexual Health / STDs News From Medical News Today [2009.10.27]
The Philippine Congress is considering legislation called the Reproductive Health and Population Development Act that would require governments at all levels to provide no- or low-cost reproductive health services, such as condoms, birth control pills, tubal ligations and vasectomies, the New York Times reports.
Published Studies Related to Ortho Evra (Norelgestromin / Estradiol Transdermal)
Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. [2005.06]
OBJECTIVE: To compare bleeding profiles and satisfaction among women using a norelgestromin/ethinyl estradiol (E2) transdermal contraceptive patch in an extended regimen to those among women using a traditional 28-day patch regimen... CONCLUSION: Compared with cyclic use, extended use of the norelgestromin/ethinyl E2 transdermal patch delayed menses and resulted in fewer bleeding days. This regimen may represent a useful alternative for women who prefer fewer episodes of withdrawal bleeding.
Satisfaction and compliance in hormonal contraception: the result of a multicentre clinical study on women's experience with the ethinylestradiol/norelgestromin contraceptive patch in Italy. [2009.06.30]
BACKGROUND: For many women finding the right contraceptive method can be challenging and consistent and correct use over a lifetime is difficult. Even remembering to take a birth control pill every day can be a challenge. The primary objective of this study was to evaluate women's experience with a weekly ethinylestradiol/norelgestromin contraceptive patch (EE/NGMN patch), given new technologies recently developed in hormonal contraception to increase women's options in avoiding daily dosing... CONCLUSION: This study demonstrated that the EE/NGMN patch is associated with high satisfaction levels and excellent compliance. At study end, the majority of women indicated that they would continue using the patch.
Effect of the ethinylestradiol/norelgestromin contraceptive patch on body composition. Results of bioelectrical impedance analysis in a population of Italian women. [2008.08.26]
BACKGROUND: As weight gain is one of the most frequently cited reasons for not using and for discontinuing hormonal contraceptives, in an open-label, single-arm, multicentre clinical study we evaluated the effect of the ethinylestradiol/norelgestromin contraceptive patch (EVRA, Janssen-Cilag International, Belgium) on body composition using bioelectrical impedance analysis (BIA)... CONCLUSION: After 6 months of treatment with the ethinylestradiol/norelgestromin contraceptive patch we found a minimal, clinically not relevant, increase in body weight less than 1 kg that could be attributed to an adaptive interstitial gel hydration. This fluctuation is physiological as confirmed by the lack of any effect on blood pressure. This could be useful in increasing women's choice, acceptability and compliance of the ethinylestradiol/norelgestromin contraceptive patch.
Adolescents' experience with the combined estrogen and progestin transdermal contraceptive method Ortho Evra. [2005.04]
BACKGROUND: The new combined estrogen & progestin contraceptive patch Ortho Evra was approved by the FDA in December 2001. To date, there is a paucity of data regarding its use in the adolescent age group. We examined adolescents' experience with this new contraceptive method... CONCLUSIONS: Ortho Evra provides excellent cycle control in adolescents. Most adolescents are satisfied with this method. Intensive efforts should be made to increase condom use by adolescents on Ortho Evra.
Clinical Trials Related to Ortho Evra (Norelgestromin / Estradiol Transdermal)
To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada) [Recruiting]
The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho
Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50
years of age who request oral contraceptive protection. Subjects on a LNG, NGM, or
norethindrone/norethindrone acetate containing oral contraceptive in a 21-day regimen
suffering from hormone withdrawal-associated symptoms such of pelvic pain or headache or
both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.
Drug Interaction - Oral Contraceptive [Completed]
The purpose of this study is to administer a combined oral contraceptive containing ethinyl
estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to
assess if the concentrations of the oral contraceptives change. The safety of this treatment
regimen will also be studied.
A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA® (a Transdermal Contraceptive Patch) [Completed]
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects [Not yet recruiting]
Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women [Active, not recruiting]
The purpose of this study is to examine the drug interactions between a protease inhibitor
(PI)-based regimen including lopinavir/ritonavir (LPV/r) and two forms of contraceptive
medications in HIV infected women.
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