EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

EVRA

EPAR summary for the public

What is Evra?

Evra is a transdermal patch (a patch that delivers a medicine across the skin). It contains two active substances: norelgestromin (6 mg) and ethinyl estradiol (600 micrograms).

What is Evra used for?

Evra is a female contraceptive. Evra is intended for women of fertile age. Its safety and effectiveness have been studied in women aged 18 to 45 years.

The medicine can only be obtained with a prescription.

How is Evra used?

Evra is used as one patch per week for three weeks, followed by a fourth week, which is patch-free. Patches must always be applied regularly, on the same day of the week. The first patch is applied on day 1, and then changed on day 8. The second patch is then changed on day 15. The patch-free interval starts on day 22 and lasts for seven days. The patch-free interval must not be longer than seven days; otherwise, additional non-hormonal contraceptive methods must be used, such as condoms. The effectiveness of Evra may be lower in women weighing over 90 kg.

The patch must be firmly applied to the buttock, abdomen (tummy), upper arm or upper back, but not on the breast, or on skin that is red, irritated or cut. The same area of skin should not be used for two consecutive patches. When a patch is taken off, it is important that it is discarded appropriately. The pack has a special device for the patient to stick the old patch before discarding. For full instructions on how to use Evra, see the Package Leaflet.

How does Evra work?

Evra is a patch version of ‘the pill’ (combined oral contraceptive pill). Using a weekly patch instead of a daily pill may help the patient to stick to using her contraception appropriately. The active substances in Evra are two hormones, ethinyl estradiol (an oestrogen) and norelgestromin (a progestogen). Ethinyl estradiol has been in use extensively in oral contraceptives for many years, and norelgestromin is very similar to another progestogen, which is also used in some oral contraceptives. Evra works like the pill by changing the body’s hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).

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How has Evra been studied?

Evra has been studied in three main studies in over 3,000 women. In two studies, Evra was compared with combined oral contraceptives: in one study, the comparator was a ‘monophasic’ contraceptive (pills containing constant amounts of the active substances over the first three weeks of the treatment cycle) and in the other study, they were ‘triphasic’ (with the amount of the active substances in the pills varying through the treatment cycle). The third study did not compare Evra with any other medicine. All of the studies lasted for a year (13 four-week cycles). The main measure of effectiveness was the number of women who became pregnant.

What benefit has Evra shown during the studies?

Overall in the three studies, 15 pregnancies occurred in women taking Evra, 12 of which were the result of a ‘method failure’ (when a pregnancy occurs despite the contraceptive being used correctly). This gives Evra a ‘Pearl Index’ of 0.90. The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 woman-years (corresponding to 1,300 cycles). The Pearl Indices for the oral contraceptives were 0.57 (monophasic) and 1.28 (triphasic). Five of the pregnancies were in women weighing over 90 kg.

What is the risk associated with Evra?

During the studies, the most common side effects with Evra (seen in more than 1 patient in 10) were headache, nausea (feeling sick) and breast tenderness. For the full list of all side effects reported with Evra, see the Package Leaflet.

Evra should not be used by women who may be hypersensitive (allergic) to norelgestromin, ethinyl estradiol or any of the other ingredients. It should not be used when a woman has, or has had, venous or arterial thrombosis (blood clots in the veins or arteries) including a stroke or a heart attack or when a woman has some of the risk factors for thrombosis (severe high blood pressure, diabetes with damage to the blood vessels, high cholesterol levels, or a family history of thrombosis). It should not be used in women who have migraine with aura (visual or other symptoms), some types of cancer or abnormal bleeding from the genital area whose cause has not been diagnosed. For the full list of restrictions, 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 female contraception. The Committee recommended that Evra be given marketing authorisation.

Other information about Evra:

The European Commission granted a marketing authorisation valid throughout the European Union for Evra to Janssen-Cilag International N.V. on 22 August 2002. The marketing authorisation was renewed on 22 August 2007.

The full EPAR for Evra is available here.

This summary was last updated in 06-2008.

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