An increased risk of thromboembolic and thrombotic disease associated with the use of combined hormonal contraceptives (CHCs) is well established.
The frequency of VTE in women using CHCs has been estimated to be 3 to 12 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of VTE may be greater with XULANE in women with a BMI ≥ 30 kg/m2 compared to women with a lower BMI. This initial higher risk declines during the first year, but users of CHCs remain at an increased risk of VTE compared to non-users of CHCs. Based on results from a few studies, there is some evidence that this is true for non-oral products as well. The risk of thromboembolic disease due to CHCs gradually disappears after CHCs use is discontinued.
To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use CHCs are followed for one year, between 1 and 5 of these women will develop a VTE.1
Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHC's.
The graph below shows the risk of developing VTE for women who are not pregnant and do not use CHCs, for women who use CHCs with a range of doses and routes of administration, for pregnant women, and for women in the postpartum period.
*Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy duration is 9 months, the incidence rate is 7 to 27 per 10,000 WY.
There may be an increased risk of venous thromboembolism (VTE) among women who use the XULANE patch compared to women who use certain oral contraceptives. See XULANE Boxed WARNING.
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.
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WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30kg/m2