Your chance of getting pregnant depends on how well you follow the directions for using Xulane. The patch is 99% effective when used as directed. The better you follow the directions, the less chance you have of getting pregnant. In clinical studies, 1 to 2 women out of 100 women got pregnant during the first year they used norelgestromin and ethinyl estradiol transdermal system. Xulane may be less effective in preventing pregnancy in women at or above 198 lbs (90kg) and is for women with a BMI less than 30 kg/m2.
In clinical trials, approximately 2% of patches completely detached and approximately 3% partially detached. It’s important to make sure to apply the Xulane patch on the upper outer arm, abdomen, buttock and back and only to skin that is clean, dry, and free of any powder, make-up, cream, oil, or lotion. Check the patch every day to make sure all edges are sticking correctly. Avoid placing the patch where it could be rubbed by tight clothing such as under a waistband.
Xulane must stick securely to the skin to work properly. If your Xulane patch has been off or partially off:
You may stop using Xulane whenever you wish if you want to become pregnant. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop using Xulane.
At the start of any patch cycle (Week 1, Day 1):
No. Your patch should be checked for proper adhesion daily. Talk to your healthcare provider if you regularly experience patch detachment.
If your Xulane patch becomes uncomfortable or your application site is red, painful or swollen, change your Xulane patch. Remove your Xulane patch and apply a new patch to a new location until your next “Patch Change Day.” The patch should not be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.
When you use Xulane you may have bleeding and spotting between periods, called unplanned bleeding. Unplanned bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Unplanned bleeding occurs most often during the first few months of Xulane use, but may also occur after you have been using Xulane for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue using Xulane on schedule. If the unplanned bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider.
Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not use all of your patches correctly, or you have symptoms associated with pregnancy, such as morning sickness or unusual breast tenderness, call your healthcare provider because you may be pregnant. Stop taking Xulane if you are pregnant.
XULANE® (norelgestromin and ethinyl estradiol transdermal system) 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol
What is XULANE?
XULANE is a prescription birth control patch for women with a BMI less than 30 kg/m2. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called norelgestromin.
Hormones from XULANE get into the blood stream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use XULANE than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects.
Limitations of Use:
XULANE may not be as effective in women weighing more than 198 lbs. (90 kg). If you weigh more than 198 lbs. (90 kg), talk to your healthcare provider about which method of birth control is right for you.
Do not use XULANE if your Body Mass Index (BMI) is 30 kg/m2 or more.
Boxed WARNING
What is the most important information I should know about XULANE?
Do not use XULANE if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control methods, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
Do not use XULANE if you have an increased risk for blood clots.
Do not use XULANE if your Body Mass Index (BMI) is 30 kg/m2 or more. Women with a BMI of 30 kg/m2 or more who use Xulane may be at a higher risk for developing blood clots compared to women with a BMI lower than 30 kg/m2.
XULANE does not protect against HIV infection (AIDS) and other sexually transmitted infections.
Who should not use Xulane?
Do not use Xulane if you have or have had blood clots; an inherited problem that makes your blood clot more than normal; history of heart attack, stroke, or certain heart valve or rhythm problems that can cause blood clots to form in the heart; high blood pressure that medicine cannot control; diabetes with kidney, eye, nerve, or blood vessel damage; certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision or any migraine headaches if you are over 35; a BMI of 30 or more; liver disease or liver tumors; unexplained vaginal bleeding; breast cancer or any cancer that is sensitive to female hormones; if you take Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood; or if you are or may be pregnant.
Before you use Xulane:
Tell your healthcare professional about all of your medical conditions, including:
Tell your healthcare professional about all medicines and herbal products that you take, including those for seizures and thyroid replacement therapy, as some of these may require dosing adjustments or may make Xulane less effective. Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medicines that may make the Xulane patch less effective.
What are the most serious risks of taking Xulane?
Xulane may cause serious side effects, including blood clots, especially if you have other risk factors, such as smoking, obesity, or age greater than 35. Some examples of blood clots are deep vein thrombosis (legs), pulmonary embolus (lungs), loss of eyesight (eyes), heart attack (heart), and stroke (brain). These can cause death or lead to permanent disability.
The risk of blood clots is highest when you first start using Xulane and when you restart Xulane or a different hormonal birth control after a break of a month or more. Some studies have reported that women who use norelgestromin and ethinyl estradiol transdermal system have a higher risk of getting a blood clot. Talk with your healthcare professional about your risk of getting a blood clot before using Xulane or deciding which type of birth control is right for you.
Call your healthcare professional right away if you have:
Leg pain that will not go away; sudden shortness of breath; sudden blindness, partial or complete; severe pain or pressure in your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking; yellowing of the skin or eyeballs.
Other serious risks include:
Liver problems including liver tumors; gallbladder disease; high blood pressure
What are the most common side effects of Xulane?
The most common side effects reported in at least 5% of women during clinical trials were breast symptoms (discomfort, swelling, or pain); nausea/vomiting; headache; skin irritation, redness, pain, swelling, itching or rash at the patch application site; stomach pain; pain during menstruation; vaginal bleeding and menstrual disorders, such as spotting or bleeding between periods; and mood, affect and anxiety disorders.
Tell your healthcare professional about any side effect that bothers you or that does not go away. These are not all the possible side effects of Xulane. For more information, ask your healthcare professional or pharmacist. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This is not all of the information you should read prior to using Xulane. Please see the accompanying Patient Information and full Prescribing Information, including Boxed WARNING.
Boxed WARNING : What is the most important information I should know about XULANE?
Do not use XULANE if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control methods, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
Do not use XULANE if you have an increased risk for blood clots.
Do not use XULANE if your Body Mass Index (BMI) is 30 kg/m2 or more. Women with a BMI of 30 kg/m2 or more who use Xulane may be at a higher risk for developing blood clots compared to women with a BMI lower than 30 kg/m2.
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