Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg, 30, B-2340 Beerse, Belgium
Female contraception.
EVRA is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
The decision to prescribe EVRA should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with EVRA compares with other CHCs (see sections 4.3 and 4.4).
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 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.
Contraceptive efficacy may be decreased in women weighing equal or greater than 90 kg.
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.
EVRA has not been studied in women with hepatic impairment. EVRA is contraindicated in women with hepatic impairment (see section 4.3).
EVRA is not indicated for post-menopausal women and is not intended for use as hormonal replacement therapy.
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.
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.
The transdermal patch should be pressed down firmly until the edges stick well.
To prevent interference with the adhesive properties of the transdermal patch, no make-up, creams, lotions, powders or other topical products should be applied to the skin area where the transdermal patch is placed or where it will be applied shortly.
It is recommended that users visually check their transdermal patch daily to ensure continued proper adhesion.
The EVRA transdermal patch should not be cut, damaged or altered in any way as this may compromise contraceptive effectiveness.
Used transdermal patches should be discarded carefully in accordance with the instructions given in section 6.6.
Contraception with EVRA begins on the first day of menses. A single transdermal patch is applied and worn for one full week (7 days). The day the first transdermal patch is applied (Day 1/Start Day) determines the subsequent Change Days. The transdermal patch Change Day will be on this day every week (cycle Days 8, 15, 22 and Day 1 of the next cycle). The fourth week is transdermal patch-free starting on Day 22.
If Cycle 1 therapy starts after first day of the menstrual cycle, a non-hormonal contraceptive should be used concurrently for the first 7 consecutive days of the first treatment cycle only.
Treatment with EVRA should begin on the first day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active (hormone containing) tablet, pregnancy must be ruled out prior to the start of treatment with EVRA. If therapy starts after the first day of withdrawal bleeding, a non-hormonal contraceptive must be used concurrently for 7 days.
If more than 7 days elapse after taking the last active oral contraceptive tablet, the woman may have ovulated and should, therefore, be advised to consult a physician before initiating treatment with EVRA. If intercourse has occurred during such an extended pill-free interval, the possibility of pregnancy should be considered.
The woman may switch any day from the progestogen-only pill (from an implant on the day of its removal, from an injectable when the next injection would be due), but a back-up barrier method of birth control must be used during the first 7 days.
After an abortion or miscarriage that occurs before 20 weeks gestation, EVRA may be started immediately. An additional method of contraception is not needed if EVRA is started immediately. Be advised that ovulation may occur within 10 days of an abortion or miscarriage.
After an abortion or miscarriage that occurs at or after 20 weeks gestation, EVRA may be started either on Day 21 post-abortion or on the first day of the first spontaneous menstruation, whichever comes first. The incidence of ovulation on Day 21 post abortion (at 20 weeks gestation) is not known.
Users who choose not to breast-feed should start contraceptive therapy with EVRA no sooner than 4 weeks after child-birth. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of EVRA or the woman has to wait for her first menstrual period.
For breast-feeding women, see section 4.6.
If the EVRA transdermal patch partly or completely detaches and remains detached, insufficient medicinal product delivery occurs.
If EVRA remains even partly detached:
A transdermal patch should not be re-applied if it is no longer sticky; a new transdermal patch should be applied immediately. Supplemental adhesives or bandages should not be used to hold the EVRA transdermal patch in place.
At the start of any transdermal patch cycle (Week One/Day 1) The user may not be protected from pregnancy. The user should apply the first transdermal patch of the new cycle as soon as remembered. There is now a new transdermal patch “Change Day” and a new “Day 1”. A non-hormonal contraceptive must be used concurrently for the first 7 days of the new cycle. If intercourse has occurred during such an extended transdermal patch-free interval, the possibility of pregnancy should be considered.
In order to postpone a menstrual period for one cycle, the woman must apply another transdermal patch at the beginning of Week 4 (Day 22) thus not observing the transdermal patch-free interval. Breakthrough bleeding or spotting may occur. After 6 consecutive weeks of transdermal patch wear, there should be a transdermal patch-free interval of 7 days. Following this, the regular application of EVRA is resumed.
If the user wishes to move the Change Day the current cycle should be completed, removing the third EVRA transdermal patch on the correct day. During the transdermal patch-free week a new Change Day may be selected by applying the first EVRA transdermal patch of the next cycle on the first occurrence of the desired day. In no case should there be more than 7 consecutive transdermal patch-free days. The shorter the transdermal patch-free interval, the higher the risk that the user does not have a withdrawal bleed and may experience breakthrough bleeding and spotting during the subsequent treatment cycle.
If transdermal patch use results in uncomfortable irritation, a new transdermal patch may be applied to a new location until the next Change Day. Only one transdermal patch should be worn at a time.
Serious ill effects have not been reported following accidental ingestion of large doses of oral contraceptives. Overdose may cause nausea or vomiting. Vaginal bleeding may occur in some females. In cases of suspected overdose, all transdermal contraceptive systems should be removed and symptomatic treatment given.
2 years.
Store in the original package in order to protect from light and moisture.
Do not refrigerate or freeze.
A sachet is composed of four layers: a low-density polyethylene film (innermost layer), an aluminium foil, a low-density polyethylene film, and an outer layer of bleached paper.
Sachets are packaged in a cardboard carton. Every carton has 3, 9 or 18 EVRA transdermal patches in individual foil-lined sachets. Sachets are wrapped per three in a transparent perforated plastic film and packed in a cardboard carton.
Not all pack sizes may be marketed.
The patch should be applied immediately upon removal from the protective sachet.
To prevent interference with the adhesive properties of EVRA, no creams, lotions or powders should be applied to the skin area where the EVRA transdermal patch is to be applied.
After use the transdermal patch still contains substantial quantities of active ingredients. Remaining hormonal active ingredients of the transdermal patch may have harmful effects if reaching the aquatic environment. Therefore, the used transdermal patch should be discarded carefully. The disposal label from the outside of the sachet should be peeled open. The used transdermal patch should be placed within the open disposal label so that the sticky surface covers the shaded area on the sachet. The disposal label should then be closed sealing the used transdermal patch within. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Used transdermal patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
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