Evra

Posology To achieve maximum contraceptive effectiveness, patients must be advised to use EVRA exactly as directed. For initiation instructions see ‘How to start EVRA’ below. Only one transdermal patch is to be worn at a time. Each used transdermal patch is removed and immediately replaced with a new one on the same day of the week (Change Day) on Day 8 and Day 15 of the cycle.

Transdermal patch changes may occur at any time on the scheduled Change Day. The fourth week is transdermal patch-free starting on Day 22. A new contraceptive cycle begins on the next day following transdermal patch-free week; the next EVRA transdermal patch should be applied even if there has been no withdrawal bleeding or if withdrawal bleeding has not yet stopped.

Under no circumstances should there be more than a 7-day transdermal patch-free interval between dosing cycles. If there are more than 7 transdermal patch-free days, the user may not be protected 3 against pregnancy. A non-hormonal contraceptive must then be used concurrently for 7 days.

The risk of ovulation increases with each day beyond the recommended contraceptive-free period. If intercourse has occurred during such an extended transdermal patch-free interval, the possibility of pregnancy should be considered. Special populations Body weight equal or greater than 90 kg Contraceptive efficacy may be decreased in women weighing equal or greater than 90 kg.

Renal impairment EVRA has not been studied in women with renal impairment. No dose adjustment is necessary but as there is a suggestion in the literature that the unbound fraction of ethinyl estradiol is higher, EVRA should be used with supervision in this population.

Hepatic impairment EVRA has not been studied in women with hepatic impairment. 3). Post-menopausal women EVRA is not indicated for post-menopausal women and is not intended for use as hormonal replacement therapy. Paediatric population Safety and efficacy have not been established in adolescents under 18 years of age.

There is no relevant use of EVRA in children and pre-menarchal adolescents. Method of administration EVRA should be applied to clean, dry, hairless, intact healthy skin on the buttock, abdomen, upper outer arm or upper torso, in a place where it will not be rubbed by tight clothing.

EVRA should not be placed on the breasts or on skin that is red, irritated or cut. Each consecutive transdermal patch should be applied to a different place on the skin to help avoid potential irritation, although they may be kept within the same anatomic site.

9% of patients, respectively. Adverse reactions that may occur at the beginning of treatment but usually diminish after the first three cycles include spotting, breast tenderness and nausea. 4. 14 Tabulated list of adverse reactions Safety was evaluated in 3 322 sexually active women who participated in three Phase III clinical trials, which were designed to evaluate contraceptive efficacy.

These subjects received six or 13 cycles of contraception (EVRA or oral contraceptive comparator), took at least one dose of study medicinal product and provided safety data. Table 1 below reflects the adverse reactions reported in clinical trials and from post-marketing experience.

Frequency MedDRA convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data). , abscess, erosion) Localised oedema* Investigations common Weight increased uncommon Blood pressure increased Lipid disorders** rare Blood glucose decreased*† Blood glucose abnormal*† * Post-marketing reports.

** Includes adverse reactions reported in clinical trials and post-marketing reports. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Warnings If any of the conditions/risk factors mentioned below is present, the suitability of EVRA should be discussed with the woman. In the event of aggravation, or first appearance of any of the conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of EVRA should be discontinued.

There is no clinical evidence indicating that a transdermal patch is, in any aspect, safer than combined oral contraceptives. 6). Risk of venous thromboembolism (VTE) The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.

Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products such as EVRA may have up to twice this level of risk. The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with EVRA, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.

There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more. In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.

However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). 7 It is estimated that out of 10,000 women who use a low dose CHC that contains levonorgestrel, about 61 will develop a VTE in one year.

Studies have suggested that the incidence of VTE in women who used EVRA is up to 2-fold higher than in users of CHCs that contain levonorgestrel. This corresponds to between about 6 and 12 VTEs in a year out of 10,000 women who use EVRA.

In both cases, the number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period. VTE may be fatal in 1-2% of cases. g. hepatic, mesenteric, renal or retinal veins and arteries. Risk factors for VTE The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).

Combined hormonal contraceptives (CHCs) should not be used in the following conditions. If one of these disorders occurs during the use of EVRA, EVRA must be discontinued immediately. g. g. g. g. 5).