The hormonal birth control patch presents women with an alternative means of birth control. The XULANE contraceptive patch offers your patients a:
The XULANE transdermal system uses a 28-day (4-week) cycle. A new patch is applied each week for three weeks (21 total days). Week 4 is patch-free. Withdrawal bleeding is expected during this time. Patch adhesion must be checked daily. XULANE must adhere securely to the skin to work properly. Women using XULANE have approximately 60% greater total ethinyl estradiol exposure compared with oral contraceptives containing 35 mcg of estrogen, which may increase risk of adverse events, including venous thromboembolism (VTE).
When used as directed. In 3 large clinical trials lasting 12 months, 3,330 women (ages 18 to 45) completed 22,155 cycles of NGMN/EE (Ortho Evra®) transdermal system use. The pregnancy rate in women aged 18 to 35 years was 1.07 (95% CI 0.60, 1.76) per 100 woman-years.
XULANE, a generic to Ortho Evra, has been available in the US since FDA approval in April 2014. Clinical trials were conducted on Ortho Evra, the reference drug. Differences exists from inclusion criteria from the more recent FDA draft Guidance on calculations of Pearl Index. The impact on Pearl Index may be minimal.
NGMN: Norelgestromin EE: Ethinyl estradiol CI: Confidence interval. See Limitations of Use
Non-invasive method
Before application, the patient should make sure her skin is clean and dry. Patients should not use lotions, creams, oils, powders, or makeup at the patch site. This may cause XULANE to fail to adhere properly or become loose. The patch may be placed on the upper outer arm, abdomen, buttock or back. The patch should be placed where it won't be rubbed by tight clothing. Do not place on breasts, cut or irritated skin, or on the same location as the previous patch. The patient should check her patch every day to make sure all edges are sticking correctly. XULANE must adhere securely to the skin to work properly.
XULANE, the generic to Ortho Evra®, has been available in the US since FDA approval in April 2014. In clinical trials with the NGMN/EE patch (Ortho Evra®), approximately 2% of the cumulative number of patches completely detached and 3% partially detached. The proportion of subjects with at least one patch that completely detached ranged from 2% to 6%, with a reduction from Cycle 1 (6%) to Cycle 13 (2%). For instructions on how to manage detachment of patches, refer to dosage and administration.
The patch must stick securely to the skin to work properly. If the XULANE patch becomes partially or completely detached or remains detached, insufficient drug delivery
occurs.
The patient should check her patch every day to make sure all edges are sticking correctly.
Please see section 2.3 (How to Apply the XULANE Patch) of the PI for more information.
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.
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)].
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m2
Patients should be counseled that XULANE does not protect against HIV infection (AIDS) and other sexually transmitted infections.
This is not all of the information you should read prior to prescribing XULANE. Click here for Full Prescribing Information, including Boxed WARNING.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30kg/m2