XULANE

XULANE- norelgestromin and ethinyl estradiol patch
A-S Medication Solutions

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m2

Cigarette Smoking and Serious Cardiovascular Events

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including Xulane, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1)].

Contraindicated in Women with a BMI ≥ 30 kg/m2

Xulane is contraindicated in women with a BMI ≥ 30 kg/m2. The risk of VTE may be greater with Xulane in women with a BMI > 30 kg/m2 compared to women with a lower BMI. [see Contraindications (4) and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Limitations of Use:

Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Xulane is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Xulane must be used exactly as directed.

Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling.

2.1 How to Use Xulane

The Xulane transdermal system uses a 28-day (4-week) cycle. A new patch is applied each week for 3 weeks (21 total days). Week 4 is patch-free. Withdrawal bleeding is expected during this time.

Every new patch should 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.

Do not cut, damage or alter the Xulane patch in any way. If the Xulane patch is cut, damaged or altered in size, contraceptive efficacy may be impaired.

On the day after Week 4 ends, a new 4-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.

2.2 How to Start Using Xulane

There are multiple options for starting the Xulane patch, and the woman should choose the option that is most appropriate (see Table 1):

Table 1: Instructions for Administration

Starting Xulane in women with no current use of hormonal contraception

The woman has two options for starting the patch and she should choose the option that is right for her:

First Day Start

The woman should apply her first patch during the first 24 hours of her menstrual period. If a patch is applied after the first 24 hours of menstruation, non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) is needed for the first 7 days of the first cycle only.
The woman should apply a new patch each week for three weeks (21 total days). Every new patch should 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.
No patch is worn during Week Four (the “Patch-Free Week”). Withdrawal bleeding is expected during this time.
On the day after Week 4 ends, a new 4-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.

Sunday Start

The woman should apply her first patch on the first Sunday after her menstrual period begins.
With this option, a non-hormonal backup method of birth control, such as a condom and spermicide or diaphragm and spermicide, is needed for the first 7 days of the first cycle only.
If her period starts on a Sunday, the first patch should be applied that day, and no backup contraception is needed.

Switching from another contraceptive method

Oral combination hormonal contraception (oral CHC)

If the woman is switching from the pill to Xulane, she should complete her current pill cycle and apply the first Xulane patch on the day she would normally start her next pill
If she does not get her period within a week after taking the last active pill, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start Xulane for contraception.
If the patch is applied more than a week after taking the last active pill, she should use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of patch use.

Transdermal system

If the woman is switching from another contraceptive transdermal system to Xulane, she should complete the current transdermal system cycle and apply the first Xulane patch on the day the next transdermal system cycle would normally start.
If she does not get her period within a week after removing the last transderamal system, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start Xulane for contraception.
If Xulane is applied more than a week after removal of the last patch, nonhormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) should be used concurrently for the first 7 days of patch use.

Vaginal ring

If the woman is switching from the vaginal ring to Xulane, she should complete her current vaginal ring cycle and apply the first Xulane patch on the day she would normally insert her next vaginal ring.
If she does not get her period within a week after removing the last vaginal ring, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start Xulane for contraception.
If the patch is applied more than a week after removal of the last vaginal ring, she should use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of patch use.

Injection

If the woman is switching from an injection contraceptive to Xulane, she should apply the first Xulane patch on the day the next injection would normally occur.

Intrauterine system (IUS)

If the woman is switching from an intrauterine system to Xulane, she should apply the first Xulane patch on the day of IUS removal. If the IUS is not removed on the first day of the menstrual cycle, nonhormonal backup contraception (such as condoms and spermicide, or diaphragm and spermicide) should be used concurrently for the first 7 days of patch use.

Implant

If the woman is switching from an implant to Xulane, she should apply the first Xulane patch on the day of implant removal.

Progestin-only pill

If the woman is switching from a progestin-only pill to Xulane, she should apply the first Xulane patch on the day the next progestin-only pill cycle would normally start.

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