Dosage & Administration
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Xulane Prescribing Information
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- 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)].
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- 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)].
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)].
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.
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.
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):
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
Sunday Start
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Switching from another contraceptive method | |
Oral combination hormonal contraception (oral CHC) |
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Transdermal system |
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Vaginal ring |
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Injection |
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Intrauterine system (IUS) |
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Implant |
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Progestin-only pill |
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Use after Childbirth
Start contraceptive therapy with Xulane in women who elect not to breastfeed no sooner than 4 weeks after childbirth due to increased risk of thromboembolism. If a woman begins using Xulane postpartum, and has not yet had a period, consider the possibility of ovulation and conception occurring prior to use of Xulane, and instruct her to use an additional method of contraception, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days. [See Warnings and Precautions (5.1) and Pregnancy (8.1).]
Use after Abortion or Miscarriage
After an abortion or miscarriage that occurs in the first trimester, Xulane may be started immediately. An additional method of contraception is not needed if Xulane is started immediately. If use of Xulane is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting Xulane for the first time. In the meantime she should be advised to use a non-hormonal contraceptive method. Ovulation may occur within 10 days of an abortion or miscarriage.
Start Xulane no earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. [See Contraindications (4) and Warnings and Precautions (5.1).]
How to Apply Xulane
CHOOSING A PLACE ON THE BODY TO PUT THE PATCH
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- The patch may be placed on the upper outer arm, abdomen, buttock or back in a place where it won’t be rubbed by tight clothing. For example, it should not be placed under the waistband of clothing.
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- The patch should not be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.
Before applying the patch:
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- The woman should make sure the skin is clean and dry.
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- She should not use lotions, creams, oils, powders, or make-up at the patch site. It may cause the patch to fail to stick properly or to become loose.
HOW TO APPLY THE PATCH
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- The woman should check her patch every day to make sure all edges are sticking correctly.
WHEN TO CHANGE THE XULANE PATCH
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- The patch works for 7 days (1 week). The woman should apply a new patch on the same day each week (her Patch Change Day) for 3 weeks in a row. She must make sure she has removed her old patch prior to applying the new patch.
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- During Week 4, she DOES NOT wear a patch. She must make sure she removes her old patch. (Her period should begin during this week.)
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- Following Week 4, she repeats the cycle of three weekly applications followed by a patch-free week.
WHAT IF THE PATCH BECOMES LOOSE OR FALLS OFF?
The patch must stick securely to the skin to work properly. If the Xulane patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs. The woman should not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it.
If a patch edge lifts up:
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- The woman should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. She should run her fingers over the entire surface area to smooth out any “wrinkles” around the edges of the patch.
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- If her patch does not stick completely, she should remove it and apply a replacement patch.
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- She should not tape or wrap the patch to her skin or reapply a patch that is partially adhered to clothing.
If the patch has been off or partially off:
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- For less than 1 Day, she should try to reapply it. If the patch does not adhere completely, she should apply a new patch immediately. (No backup contraception is needed and her Patch Change Day will stay the same).
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- For more than 1 Day or if she is not sure for how long, she may not be protected from pregnancy. To reduce this risk, she should apply a new patch and start a new 4-week cycle. She will now have a new Patch Change Day and MUST USE NON-HORMONAL BACKUP CONTRACEPTION (such as a condom and spermicide or diaphragm and spermicide) for the first week of her new cycle.
IF THE WOMAN FORGETS TO CHANGE HER PATCH
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- at the start of any patch cycle (Week 1/Day 1): SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should apply the first patch of her new cycle as soon as she remembers. There is now a new “Patch Change Day” and a new “Day 1.” The woman must use back-up contraception, such as a condom and spermicide or diaphragm and spermicide, for the first week of the new cycle.
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- in the middle of the patch cycle (Week 2/Day 8 or Week 3/Day 15),
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- for 1 or 2 days (up to 48 hours), she should apply a new patch immediately. The next patch should be applied on the usual “Patch Change Day.” No back-up contraception is needed.
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- for more than 2 days (48 hours or more), SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should stop the current contraceptive cycle and start a new 4-week cycle immediately by putting on a new patch. There is now a new “Patch Change Day” and a new “Day 1.” The woman must use back-up contraception for 1 week.
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- at the end of the patch cycle (Week 4/Day 22),
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- If the woman forgets to remove her patch, she should take it off as soon as she remembers. The next cycle should be started on the usual “Patch Change Day,” which is the day after Day 28. No back-up contraception is needed.
Under no circumstances should there be more than a 7-day patch-free interval between cycles. If there are more than 7 patch-free days, THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY and back-up contraception, such as a condom and spermicide or diaphragm and spermicide, must be used for 7 days. As with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended drug-free period. If she has had intercourse during such an extended patch-free interval, consider the possibility of pregnancy.
Change Day Adjustment
If the woman wishes to change her Patch Change Day, she should complete her current cycle, removing the third Xulane patch on the correct day. During the patch-free week, she may select an earlier Patch Day Change by applying a new Xulane patch on the desired day. In no case should there be more than 7 consecutive patch-free days.
Breakthrough Bleeding or Spotting
In the event of unscheduled or breakthrough bleeding or spotting (bleeding that occurs on the days that Xulane is worn), treatment should be continued. If unscheduled bleeding persists longer than a few cycles, consider causes other than Xulane.
If the woman does not have scheduled or withdrawal bleeding (bleeding that should occur during the patch-free week), she should resume treatment on the next scheduled Change Day. If Xulane has been used correctly, the absence of withdrawal bleeding is not necessarily an indication of pregnancy. Nevertheless, consider the possibility of pregnancy, especially if absence of withdrawal bleeding occurs in 2 consecutive cycles. Discontinue Xulane if pregnancy is confirmed.
In Case of Skin Irritation
If patch use results in uncomfortable irritation, the patch may be removed and a new patch may be applied to a different location until the next Change Day. Only one patch should be worn at a time.
Additional Instructions for Dosing
Unscheduled bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing hormonal contraceptives. In case of breakthrough bleeding, as in all cases of irregular bleeding from the vagina, consider nonfunctional causes. In case of undiagnosed persistent or recurrent abnormal bleeding from the vagina, take adequate diagnostic measures to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another method of contraception may solve the problem.
Use of Hormonal Contraceptives in the Event of a Missed Menstrual Period
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- If the woman has not adhered to the prescribed schedule, consider the possibility of pregnancy at the time of the first missed period. Discontinue use of Xulane if pregnancy is confirmed.
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- If the woman has adhered to the prescribed regimen and misses one period, she should continue using her contraceptive patches. However, if she has adhered to the prescribed regimen, misses one period and has symptoms associated with pregnancy, rule out pregnancy. Discontinue Xulane use if pregnancy is confirmed.
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- If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Xulane use if pregnancy is confirmed.
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.
Use in Specific Populations
Effects of Age, Body Weight, Body Surface Area and Race
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.
Xulane is contraindicated in females who are known to have or develop the following conditions:
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- At high risk of arterial or venous thromboembolic events. Examples include women who:
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- Smoke, if over age 35 [see Boxed Warning, and Warnings and Precautions (5.1)]
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- Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
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- Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
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- Have cerebrovascular disease [see Warnings and Precautions (5.1)]
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- Have coronary artery disease [see Warnings and Precautions (5.1)]
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- 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)]
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- Have uncontrolled hypertension [see Warnings and Precautions (5.5)]
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- Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7)]
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- Have headaches with focal neurological symptoms or have migraine headaches with aura
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- Women over age 35 with any migraine headaches [see Warnings and Precautions (5.8)]
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- Body Mass Index ≥ 30 kg/m2 [see Warnings and Precautions (5.1)]
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- 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)]
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- Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)]
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- 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)]
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- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [See Warnings and Precautions (5.12)]
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- 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)]