Loading…
EVRA is a brand name for Norelgestromin, supplied as a patch (extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EVRA (norelgestromin and ethinyl estradiol extended release patch) is indicated for: • The prevention of pregnancy The pharmacokinetic profile for the EVRA transdermal system is different from that of an oral contraceptive. The clinical relevance of the differences in PK profiles between transdermal and oral delivery…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment To achieve maximum contraceptive effectiveness, the EVRA transdermal system must be used exactly as directed. Transdermal Contraceptive System Overview This system uses a 28-day, four-week cycle.
A new patch is applied each week for three weeks – 21 total days. Week Four is patch-free. Withdrawal bleeding is expected during this time. This means that every new patch will be applied on the same day of the week. This day is known as the “Patch Change Day”.
For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. The EVRA patch should not be cut, damaged or altered in any way. If the EVRA patch is cut, damaged or altered in size, contraceptive efficacy may be impaired.
On the day after Week Four ends, a new four-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles. Clinical trials demonstrated that subjects randomized to EVRA were able to adhere to the weekly dosing regimen better than with daily dosing of oral contraceptives (see 14 CLINICAL TRIALS).
Health Canada has not authorized an indication for pediatric use. 1 Pediatrics. 4 Administration 1 If the patient is starting EVRA for the first time, she should wait until the day she begins her menstrual period. Either a First Day start or Sunday start may be utilized (see below).
The day she applies her first patch will be Day 1. Her “Patch Change Day” will be on this day every week. 2 • for First Day start: the patient should apply her first patch during the first 24 hours of her period. OR • for Sunday start: the patient should apply her first patch on the first Sunday after her period starts.
She must use back-up contraception for the first week of her first cycle only. If the menstrual period begins on a Sunday, the first patch should be applied on that day. No back-up contraception is needed.
For both a First Day start and a Sunday start:
A non-hormonal contraceptive (such as a condom or diaphragm) should be used concurrently for the first 7 consecutive days of the first treatment cycle. Product Monograph EVRA® (norelgestromin and ethinyl estradiol extended release patch) Page 7 of 74 3 Where to apply the patch.
). • Cigarette smoking increases the risk of serious cardiovascular events associated with the use of hormonal contraceptives. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.
For this reason, hormonal contraceptives, including EVRA, should not be used by women who are over 35 years of age and smoke (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). • Hormonal contraceptives DO NOT PROTECT against sexually transmitted infections (STIs) including HIV/AIDS.
For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH hormonal contraceptives. 2 Recommended Dose and Dosage Adjustment To achieve maximum contraceptive effectiveness, the EVRA transdermal system must be used exactly as directed.
Transdermal Contraceptive System Overview This system uses a 28-day, four-week cycle. A new patch is applied each week for three weeks – 21 total days. Week Four is patch-free. Withdrawal bleeding is expected during this time. This means that every new patch will be applied on the same day of the week.
This day is known as the “Patch Change Day”. For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. The EVRA patch should not be cut, damaged or altered in any way.
If the EVRA patch is cut, damaged or altered in size, contraceptive efficacy may be impaired. On the day after Week Four ends, a new four-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles.
Clinical trials demonstrated that subjects randomized to EVRA were able to adhere to the weekly dosing regimen better than with daily dosing of oral contraceptives (see 14 CLINICAL TRIALS). Health Canada has not authorized an indication for pediatric use.
3 Pharmacokinetics). 1 Pediatrics Pediatrics (˂18 years of age): No data in female patients under the age of 18 are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics: No data in post-menopausal women are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
2 CONTRAINDICATIONS EVRA transdermal system is contraindicated in women: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid- antibodies (anticardiolipin antibodies, lupus anticoagulant) o severe dyslipoproteinemia o over age 35 and smoke o diabetes mellitus with vascular involvement o major surgery associated with an increased risk of post-operative thromboembolism o prolonged immobilization 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • The risk of venous thromboembolism (VTE) in users of the ORTHO EVRA patch (the formulation of EVRA marketed in the United States) compared to users of oral contraceptives containing norgestimate (NGM) and 35 μg of ethinyl estradiol (EE) was assessed in two epidemiological studies with a nested case-control design conducted in women aged 15 to 44 years.
52)]. 6)] (see 7 WARNINGS AND PRECAUTIONS, General). • Prescribers are advised to carefully assess a patient’s baseline and cumulative risk of thromboembolism before prescribing hormonal contraceptives, including EVRA. Obesity (BMI ≥ 30 kg/m2) has been identified as a risk factor for venous thromboembolism.
Particular caution should be exercised when prescribing hormonal contraceptives, including EVRA, to women who are obese (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, General, Cardiovascular, Endocrine and Metabolism, Hematologic and
EVRA transdermal system is contraindicated in women: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid- antibodies (anticardiolipin antibodies, lupus anticoagulant) o severe dyslipoproteinemia o over age 35 and smoke o diabetes mellitus with vascular involvement o major surgery associated with an increased risk of post-operative thromboembolism o prolonged immobilization
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The patch 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 won’t be rubbed by tight clothing. EVRA should not be placed on skin that is red, irritated or cut, nor should it be placed on the breast.
To prevent interference with the adhesive properties of EVRA, no make-up, creams, lotions, powders or other topical products should be applied to the skin area where the EVRA patch is currently placed or will be applied shortly. 4 Application of the EVRA patch The foil pouch is opened by tearing it along the edge using the fingers.
A corner of the patch is grasped firmly and gently removed from the foil pouch. Sometimes patches can stick to the inside of the pouch – the patient should be careful not to accidentally remove the clear liner as she removes the patch.
Then half of the clear protective liner is peeled away. The patient should avoid touching the sticky surface of the patch. 5 The patch is positioned on the skin and the other half of the liner is removed. The patient should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the edges stick well.
She should check her patch every day to make sure it is sticking. 6 The patch is worn for 7 days (one week). On the “Patch Change Day,” Day 8, the used patch is removed and a new one is applied immediately. The used patch still contains some active hormones – it should be thrown away by carefully folding it in half so that it sticks to itself.
” Patch changes may occur at any time on the Change Day. Consecutive EVRA patches should be applied to a new spot on the skin to help avoid potential irritation, although they may be kept within the same anatomic site. 8 Week Four is patch-free (Day 22 through Day 28), thus completing the four-week contraceptive cycle.
Bleeding is expected during this time. 9 The next four-week cycle is started by applying a new patch on the usual “Patch Change Day,” the day after Day 28, no matter when the menstrual period begins or ends. Under no circumstances should there be more than a 7-day patch- free interval between dosing cycles.
Product Monograph EVRA® (norelgestromin and ethinyl estradiol extended release patch) Page 8 of 74 Patch adhesion was assessed indirectly by replacement rates for complete and partial patch detachment. 9%). Similarly, in a small study of patch wear under conditions of physical exertion and variable temperature and humidity, less than 2% of patches were replaced for complete or partial detachment.
If the EVRA patch lifts at the edges or completely detaches and remains detached, insufficient drug delivery occurs. If EVRA remains even partly detached: • for less than one day (up to 24 hours), it should be reapplied to the same place or replaced with a new EVRA patch immediately.
No additional contraception is needed. ” • for more than one day (> 24 hours) OR if the user is not aware when the patch lifted or became detached, the user may not be protected from pregnancy. The user should stop the current contraceptive cycle and start a new cycle immediately by putting on a new EVRA patch.
” A non-hormonal contraception must be used for the first week of […]
1 Pediatrics. 4 Administration 1 If the patient is starting EVRA for the first time, she should wait until the day she begins her menstrual period. Either a First Day start or Sunday start may be utilized (see below). The day she applies her first patch will be Day 1.
Her “Patch Change Day” will be on this day every week. 2 • for First Day start: the patient should apply her first patch during the first 24 hours of her period. OR • for Sunday start: the patient should apply her first patch on the first Sunday after her period starts.
She must use back-up contraception for the first week of her first cycle only. If the menstrual period begins on a Sunday, the first patch should be applied on that day. No back-up contraception is needed.
For both a First Day start and a Sunday start:
A non-hormonal contraceptive (such as a condom or diaphragm) should be used concurrently for the first 7 consecutive days of the first treatment cycle. Product Monograph EVRA® (norelgestromin and ethinyl estradiol extended release patch) Page 7 of 74 3 Where to apply the patch.
The patch 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 won’t be rubbed by tight clothing. EVRA should not be placed on skin that is red, irritated or cut, nor should it be placed on the breast.
To prevent interference with the adhesive properties of EVRA, no make-up, creams, lotions, powders or other topical products should be applied to the skin area where the EVRA patch is currently placed or will be applied shortly. 4 Application of the EVRA patch The foil pouch is opened by tearing it along the edge using the fingers.
A corner of the patch is grasped firmly and gently removed from the foil pouch. Sometimes patches can stick to the inside of the pouch – the patient should be careful not to accidentally remove the clear liner as she removes the patch.
Then half of the clear protective liner is peeled away. The patient should avoid touching the sticky surface of the patch. 5 The patch is positioned on the skin and the other half of the liner is removed. The patient should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the edges stick well.
She should check her patch every day to make sure it is sticking. 6 The patch is worn for 7 days (one week). On the “Patch Change Day,” Day 8, the used patch is removed and a new one is applied immediately. The used patch still contains some active hormones – it should be thrown away by carefully folding it in half so that it sticks to itself.
” Patch changes may occur at any time on the Change Day. Consecutive EVRA patches should be applied to a new spot on the skin to help avoid potential irritation, although they may be kept within the same anatomic site. 8 Week Four is patch-free (Day 22 through Day 28), thus completing the four-week contraceptive cycle.
Bleeding is expected during this time. 9 The next four-week cycle is started by applying a new patch on the usual “Patch Change Day,” the day after Day 28, no matter when the menstrual period begins or ends. Under no circumstances should there be more than a 7-day patch- free interval between dosing cycles.
Product Monograph EVRA® (norelgestromin and ethinyl estradiol extended release patch) Page 8 of 74 Patch adhesion was assessed indirectly by replacement rates for complete and partial patch detachment. 9%). Similarly, in a small study of patch wear under conditions of physical exertion and variable temperature and humidity, less than 2% of patches were replaced for complete or partial detachment.
If the […]