Dosage & 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.
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Xulane Prescribing Information
• Cigarette Smoking and Serious Cardiovascular Events
Xulane is contraindicated in females who are known to have or develop the following conditions:
• At high risk of arterial or venous thromboembolic events. Examples include women who:o Smoke, if over age 35[see Boxed Warning, and Warnings and Precautions (5.1)]o Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings and Precautions (5.1)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension[see Warnings and Precautions (5.5)]o Have diabetes mellitus with vascular disease[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms or have migraine headaches with aura▪ Women over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
• Body Mass Index ≥ 30 kg/m2[see Warnings and Precautions (5.1)]• Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions (5.3),Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]• Undiagnosed abnormal uterine bleeding[see Warnings and Precautions (5.9)]• Pregnancy, because there is no reason to use hormonal contraceptives during pregnancy[see Warnings and Precautions (5.10)and Use in Specific Populations (8.1)]• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[SeeWarnings and Precautions (5.12)]• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations[see Warnings and Precautions (5.4)]
• At high risk of arterial or venous thromboembolic events• BMI ≥ 30 kg/m2• Breast cancer or other estrogen- or progestin-sensitive cancer• Liver tumors or liver disease• Undiagnosed abnormal uterine bleeding• Pregnancy• Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
• Stop Xulane if an arterial or venous thromboembolic event (VTE) occurs.• Stop Xulane if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Xulane at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. Discontinue use of Xulane during prolonged immobilization and resume treatment based on clinical judgment.• Start Xulane no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• Before starting Xulane, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy.[see Contraindications (4)].
The use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity. Xulane is contraindicated in women over 35 years of age who smoke
The use of CHCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs. The risk of VTE may be greater with Xulane in women with a BMI ≥ 30 kg/m2compared to women with a lower BMI
While the increased risk of VTE associated with use of CHCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). 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. 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 CHC use is discontinued.
Figure 1 shows the risk of developing a 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. 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.
• Contraindicated in Women with a BMI ≥ 30 kg/m2
Xulane is contraindicated in females who are known to have or develop the following conditions:
• At high risk of arterial or venous thromboembolic events. Examples include women who:o Smoke, if over age 35[see Boxed Warning, and Warnings and Precautions (5.1)]o Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings and Precautions (5.1)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension[see Warnings and Precautions (5.5)]o Have diabetes mellitus with vascular disease[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms or have migraine headaches with aura▪ Women over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
• Body Mass Index ≥ 30 kg/m2[see Warnings and Precautions (5.1)]• Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions (5.3),Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]• Undiagnosed abnormal uterine bleeding[see Warnings and Precautions (5.9)]• Pregnancy, because there is no reason to use hormonal contraceptives during pregnancy[see Warnings and Precautions (5.10)and Use in Specific Populations (8.1)]• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[SeeWarnings and Precautions (5.12)]• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations[see Warnings and Precautions (5.4)]
• At high risk of arterial or venous thromboembolic events• BMI ≥ 30 kg/m2• Breast cancer or other estrogen- or progestin-sensitive cancer• Liver tumors or liver disease• Undiagnosed abnormal uterine bleeding• Pregnancy• Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
• Stop Xulane if an arterial or venous thromboembolic event (VTE) occurs.• Stop Xulane if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Xulane at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. Discontinue use of Xulane during prolonged immobilization and resume treatment based on clinical judgment.• Start Xulane no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• Before starting Xulane, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy.[see Contraindications (4)].
The use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity. Xulane is contraindicated in women over 35 years of age who smoke
The use of CHCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs. The risk of VTE may be greater with Xulane in women with a BMI ≥ 30 kg/m2compared to women with a lower BMI
While the increased risk of VTE associated with use of CHCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). 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. 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 CHC use is discontinued.
Figure 1 shows the risk of developing a 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. 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.
Warnings and Precautions (
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
Xulane is contraindicated in females who are known to have or develop the following conditions:
• At high risk of arterial or venous thromboembolic events. Examples include women who:o Smoke, if over age 35[see Boxed Warning, and Warnings and Precautions (5.1)]o Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings and Precautions (5.1)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension[see Warnings and Precautions (5.5)]o Have diabetes mellitus with vascular disease[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms or have migraine headaches with aura▪ Women over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
• Body Mass Index ≥ 30 kg/m2[see Warnings and Precautions (5.1)]• Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions (5.3),Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]• Undiagnosed abnormal uterine bleeding[see Warnings and Precautions (5.9)]• Pregnancy, because there is no reason to use hormonal contraceptives during pregnancy[see Warnings and Precautions (5.10)and Use in Specific Populations (8.1)]• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[SeeWarnings and Precautions (5.12)]• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations[see Warnings and Precautions (5.4)]
• At high risk of arterial or venous thromboembolic events• BMI ≥ 30 kg/m2• Breast cancer or other estrogen- or progestin-sensitive cancer• Liver tumors or liver disease• Undiagnosed abnormal uterine bleeding• Pregnancy• Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
• Stop Xulane if an arterial or venous thromboembolic event (VTE) occurs.• Stop Xulane if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Xulane at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. Discontinue use of Xulane during prolonged immobilization and resume treatment based on clinical judgment.• Start Xulane no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• Before starting Xulane, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy.[see Contraindications (4)].
The use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity. Xulane is contraindicated in women over 35 years of age who smoke
The use of CHCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs. The risk of VTE may be greater with Xulane in women with a BMI ≥ 30 kg/m2compared to women with a lower BMI
While the increased risk of VTE associated with use of CHCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). 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. 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 CHC use is discontinued.
Figure 1 shows the risk of developing a 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. 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.
In 3 large clinical trials lasting 12 months, in North America, Europe and South Africa, 3,330 women (ages 18 to 45) completed 22,155 cycles of norelgestromin and ethinyl estradiol transdermal system use, the pregnancy rate in women aged 18 to 35 years was 1.07 (95% confidence interval 0.60, 1.76) per 100 woman-years of norelgestromin and ethinyl estradiol transdermal system use. The racial distribution was 91% Caucasian, 4.9% Black, 1.6% Asian, and 2.4% Other.
With respect to weight, 5 of the 15 pregnancies reported with norelgestromin and ethinyl estradiol transdermal system use were among women with a baseline body weight ≥ 198 lbs., which constituted < 3% of the study population. The greater proportion of pregnancies among women at or above 198 lbs. was statistically significant and suggests that norelgestromin and ethinyl estradiol transdermal system may be less effective in these women.
In the clinical trials with norelgestromin and ethinyl estradiol transdermal system, 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
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.
Xulane® (norelgestromin and ethinyl estradiol transdermal system) is available in one strength of 150 mcg/day norelgestromin (NGMN) and 35 mcg/day ethinyl estradiol (EE).
Xulane® is a 14 cm² peach, transdermal system printed with “Xulane® (norelgestromin and ethinyl estradiol) 150/35 mcg per day” in brown ink. Each system contains 4.86 mg norelgestromin, USP and 0.53 mg ethinyl estradiol, USP.
The effects of age, body weight, body surface area and race on the PK of NGMN and EE were evaluated in 230 healthy women from nine pharmacokinetic studies of single 7-day applications of norelgestromin and ethinyl estradiol transdermal system. For both NGMN and EE, increasing age, body weight and body surface area each were associated with slight decreases in Css and AUC values. However, only a small fraction (10% to 25%) of the overall variability in the PK of NGMN and EE following application of norelgestromin and ethinyl estradiol transdermal system may be associated with any or all of the above demographic parameters. There was no significant effect of race with respect to Caucasians, Hispanics and Blacks.