The figures below present mean PK profiles for NGMN and EE, respectively, following once-daily administration of an oral contraceptive (containing NGM 250 mcg /EE 35 mcg) compared to the 7-day norelgestromin and ethinyl estradiol transdermal system (containing NGMN 4.86 mg /EE 0.53 mg) during Cycle 2 in 32 healthy female volunteers.
*Following once-daily administration of an oral contraceptive for two cycles or application of NGM for two cycles to the buttock in healthy female volunteers.
[Oral contraceptive: Cycle 2, Days 15 to 21, Xulane: Cycle 2, Week 3]
*Mean (%CV) NGMN and EE steady state pharmacokinetic parameters
following application of norelgestromin and ethinyl estradiol transdermal
system and once-daily administration of an oral contraceptive (containing
NGM 250 mcg /EE 35 mcg) in healthy female volunteers
**Cycle 2, Week 3
†Cycle 2, Day 21
‡NGM is rapidly metabolized to NGMN following oral administration
§Average weekly exposure, calculated as AUC24 x 7
In general, overall exposure for NGMN and EE (AUC and Css) was higher in subjects treated with norelgestromin and ethinyl estradiol transdermal system for both Cycle 1 and Cycle 2, compared to that for the oral contraceptive. Cmax values were higher in subjects administered the oral contraceptive. Under steady state conditions, AUC0-168 and Css for EE were approximately 55% and 60% higher, respectively, for norelgestromin and ethinyl estradiol transdermal system, and the Cmax was about 35% higher for the oral contraceptive, respectively.
Inter-subject variability (%CV) for PK parameters following delivery from NGMN and EE transdermal system was higher relative to the variability determined from the oral contraceptive. The mean PK profiles are different between the two products and caution should be exercised when making a direct comparison of these PK parameters.
Ethinyl Estradiol Exposure
Higher estrogen exposure may increase the risk of adverse reactions, including venous thromboembolism (VTE). The Area Under the Curve (AUC) for ethinyl estradiol (EE) is approximately 60% higher in women using XULANE compared to oral contraceptives containing EE 35 mcg. In contrast, the peak concentration (Cmax) for EE is approximately 25% lower in women using norelgestromin and ethinyl estradiol transdermal system [see Clinical Pharmacology (12.3)].
Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a transdermal delivery system is an appropriate method of contraception.
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)].
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m2
Do not prescribe Xulane to women who are known to have the following conditions:
Thromboembolic Disorders and Other Vascular Conditions
Ethinyl Estradiol Exposure
Risk of liver enzyme elevations with concomitant hepatitis C treatment
High Blood Pressure
Carbohydrate and Lipid Metabolic Effects
Other Warnings and Precautions
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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