What is Evra?
Evra is a transdermal patch (a patch that releases the medicine through the skin). Contains two active ingredients, norelgestromin (6 mg) and ethinyl estradiol (600 micrograms).
What is Evra used for?
Evra is a female contraceptive indicated for women of childbearing age. Its safety and efficacy have been studied in women aged 18 to 45 years.
The medicine can only be obtained with a prescription.
How is Evra used?
An Evra patch is used per week for three weeks, the fourth week without a patch. The patches must be applied regularly, ie always on the same day of the week. The first patch is applied on day 1 and changed on day 8; the second changed on day 15. The patch-free interval starts on day 22 and lasts seven days. This interval should not exceed seven days, otherwise non-hormonal contraceptive methods, such as condoms, should be used concomitantly. The effectiveness could be reduced in women weighing more than 90 kg.
The patch should be applied firmly to the buttock, abdomen (abdomen), the upper external part of the arm or the upper part of the back, but not to the breasts or to red, irritated or cut skin. Do not apply two patches on the same part of skin. Once removed, the used patch must be removed properly. The package is equipped with a special device where the used patch must be glued before throwing it away. For complete instructions on how to use Evra, see the package leaflet.
How does Evra work?
Evra is the patch version of the "pill" (combined oral contraceptive pill). Using a weekly patch instead of a daily pill can help the patient to use their contraception properly. The active ingredients of Evra are two hormones, ethinyl estradiol (an estrogen) and norelgestromin (a progestin). Ethinylestradiol has been widely used for many years in oral contraceptives and norelgestromin is very similar to another progestin, which is also used in some oral contraceptives. Evra acts as the "pill" by varying the body's hormonal balance to prevent ovulation, altering the cervical mucus and thinning the endometrium (internal lining of the uterus).
What studies have been carried out on Evra?
Evra has been studied in three main studies involving 3, 000 women. In two studies, Evra was compared with combined oral contraceptives: in one study, the comparator was a monophasic contraceptive (pills with fixed amounts of active ingredients during the first three weeks of the treatment cycle), while the other study was triphasic ( with quantities of variable active ingredients during the treatment cycle). The third did not compare Evra with other medicines. All studies lasted one year (13 four-week cycles) and the main measure of effectiveness was the number of women who fell during pregnancy.
What benefit has Evra shown during the studies?
During the three studies 15 pregnancies occurred in women who used Evra, 12 of which were due to failure of the method (when a pregnancy occurs despite proper use of the contraceptive). Evra's "Pearl Index" is therefore 0.90. The Pearl index is the standard method for assessing the effectiveness of contraceptives, which is the number of unwanted pregnancies that occurred in 100 women in a year (corresponding to 1 300 cycles). The Pearl indices for oral contraceptives were 0.57 (monophasic) and 1.28 (triphasic). Five of the pregnancies occurred in women weighing more than 90 kg.
What are the risks associated with Evra?
During the studies the most common side effects of Evra (seen in more than 1 patient in 10) were headache, nausea and mammary hyperesthesia. For the complete list of all side effects, see the package leaflet.
Evra must not be used in women who are hypersensitive (allergic) to norelgestromin, to ethinyl estradiol or to other ingredients. It must not be used by women who have, or have had, venous or arterial thrombosis (blood clots in the veins or arteries), including a stroke or heart attack, or who have certain risk factors for thrombosis (very high blood pressure, diabetes). with damage to blood vessels, high levels of cholesterol or hereditary predisposition to thrombosis). It should not be used in women who suffer from migraine with aura (visual or other symptoms), certain types of cancer or abnormal bleeding from the genital area whose cause has not been diagnosed. For the full list of limitations, see the package leaflet.
Why has Evra been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Evra's benefits are greater than its risks for use as a female contraceptive and recommended that it be given marketing authorization.
More information on EVRA
On 22 August 2002, the European Commission issued a valid EU-wide marketing authorization for Evra to Janssen-Cilag International NV. The marketing authorization was renewed on 22 August 2007.
The full EPAR for Evra can be found here.
Last update of this summary: 06-2008
