About
Xulane

used-patch-img

The patch can be placed on your upper outer arm, abdomen, buttock or back in a place where it won’t be rubbed by tight clothing. Do not place on your breasts or the same skin area as the previous patch. Only apply to clean, dry skin. Do not use lotions, creams, oils, powders, or makeup at the patch site. Check the patch every day to make sure all edges are sticking correctly. Your patch must stick securely to your skin to work properly. Do not try to reapply a patch if it is no longer sticky. Do not tape or wrap the patch to your skin.

See how to apply it >

SIZE UP XULANE

xulane patch
coin
lipstick
* Not actual size.
  • How does Xulane work?

    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. This type of combination hormonal contraception prevents pregnancy, and is 99% effective when used as directed. Your chance of getting pregnant depends on how well you follow the directions for using Xulane. The better you follow the directions, the less chance you have of getting pregnant.

    Limitations of Use:

    Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Do not use Xulane if your BMI is 30 kg/m2 or more.

    Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

    Hormones from the patch enter the bloodstream 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 the patch 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, including blood clots.

  • How do I start Xulane?

    If you are not currently using hormonal birth control, there are two options for starting the patch. Choose the option that is right for you:

    FIRST DAY START

    Apply your first patch during the first 24 hours of your menstrual period.

    SUNDAY START

    Apply your first patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first patch that day, and no backup birth control is needed.

    IF SWITCHING FROM THE PILL OR VAGINAL CONTRACEPTIVE RING TO THE PATCH

    Complete your current pill cycle or vaginal ring cycle. Apply your first patch on the day you would normally start your next pill or insert your next vaginal ring. If you do not get your period within 1 week after taking your last active pill or removing your last vaginal ring, check with your healthcare provider to make sure you are not pregnant. You may still go ahead and start the patch for contraception. If you apply your patch more than 1 week after taking your last active pill or removing your last vaginal ring, use a non-hormonal contraceptive method with the patch for the first 7 days of patch use.

    IF USING AFTER CHILDBIRTH

    If you are not breastfeeding, wait 4 weeks before using the patch and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting the patch.

    IF USING AFTER ABORTION OR MISCARRIAGE

    You may start the patch immediately after a miscarriage or abortion. You do not need to use another contraceptive method.

    If you do not start the patch within 5 days after a first trimester miscarriage or abortion, use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, while you wait for your period to start.You should follow the instructions above for First day start or Sunday start based on what's right for you, and read the full Patient Information for starting Xulane®.

    If you are starting the patch after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using the patch and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your miscarriage or abortion, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting the patch.

    IF YOU ARE NOT SURE HOW TO USE YOUR XULANE PATCH:

    Talk to your healthcare provider for instructions before using your Xulane patch.

  • How do I apply Xulane?

    Use Xulane exactly as your healthcare provider tells you to use it. Place the patch on your upper outer arm, abdomen, buttock or back in a place where it won’t be rubbed by tight clothing. For example, you should not place it under the waistband of clothing. Do not place on your breasts, cut or irritated skin, or the same skin area as your last patch. Do not cut, damage, or alter the Xulane Patch in any way. Patch images shown below are for illustration purposes only and do not represent the actual Xulane Patch.

    Your Xulane patch must stick securely to your skin to work properly. Do not tape or wrap the patch to your skin that is no longer sticky, if it has become stuck to itself or another surface, has material stuck to it or partially adhered to clothing.

    BEFORE APPLYING

    Make sure your skin is clean and dry. Don’t use lotions, creams, oils, powders, or makeup at the patch site. This may cause the patch to fail to stick properly or become loose.

    APPYLING THE PATCH

    • Tear open the pouch at the top edge and one side edge. Peel open the foil pouch and gently remove the contents of the foil pouch and discard the additional pieces of film above and below the patch.

    • Peel away half of the clear plastic. Avoid touching the sticky surface with your fingers.

    • Apply the sticky side of the patch on your clean, dry skin. Remove the other half of the clear plastic and attach the entire patch to your skin.

    • Press firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. Run your fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the patch.

      CHECK YOUR PATCH EVERY DAY TO MAKE SURE ALL EDGES ARE STICKING CORRECTLY.

  • When do I change it?

    Wear one Xulane patch at a time. Make sure you remove your old patch before applying your new patch. Do not skip using any patches, even if you do not have sex. Xulane is applied in a 4-week cycle:

    • Apply your patch one time each week for 3 weeks (21 total days).
    • Apply each new patch on the same day of the week. This day will be your “Patch Change Day.” For example, if you apply your first patch on a Monday, all of your patches should be applied on a Monday. Remember to remove the old patch.
    • Do not apply your patch during week 4. Make sure you remove your old patch. This is your patch-free week. Your menstrual period should start during your patch-free week.
    • Begin a new 4-week cycle by applying a new patch on the day after week 4 ends. Repeat the cycle of 3 weekly applications followed by a patch-free week.
    • Your patch should never be off for more than 7 days in a row. If your patch is off for more than 7 days in a row and you have sex during this time, you could become pregnant.
    • If you miss a period you might be pregnant. Some women miss their periods or have light periods on hormonal birth control methods even when they are not pregnant. Call your healthcare provider if you miss one period and have not used your patch every day or you miss two periods in a row.

    To throw away the Xulane patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash. Used Xulane patches should not be flushed in the toilet.

    If your patch becomes uncomfortable or your application site is red, painful, or swollen, remove your patch and apply a new patch to a new location until your next “Patch Change Day”.

  • What if I forget to change it?

    If you forget to change or remove your patch…

    At the start of any patch cycle (Week 1, Day 1):

    You could become pregnant. You must use a backup contraception method for 7 days. Apply the first patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1.

    In the middle of your patch cycle (Week 2 or Week 3):

    If you forget to change your patch for 1 or 2 days, apply a new patch as soon as you remember. Apply your next patch on your normal “Patch Change Day.” No backup contraception method is needed.

    If you forget to change your patch for more than 2 days, you could become pregnant. Start a new 4-week cycle as soon as you remember by putting on a new patch. You now have a different “Patch Change Day” and a new Day 1. You must use a backup contraception method for the first 7 days of your new cycle.

    At the end of your patch cycle (Week 4):

    If you forget to remove your patch, take it off as soon as you remember. Start your next cycle on your normal “Patch Change Day,” the day after Day 28. No backup contraception method is needed.

    At the start of your next patch cycle:

    You could become pregnant. Apply the first patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1. Use a non-hormonal backup contraception method, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your new 4-week patch cycle.

    If you have trouble remembering to change your patch, talk to your healthcare provider about how to make patch changing easier or about using another method of contraception.

  • What if it becomes loose or falls off?

    Your patch must stick securely to your skin to work properly. Do not try to reapply the 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. Do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing.

    If your patch edge lifts up:

    Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. Run your fingers over the entire surface area to smooth out any “wrinkles” around the edges of the patch. If your patch does not stick completely, remove it and apply a new patch. Do not tape or wrap the patch to your skin or reapply a patch that is partially stuck to clothing.

    If your patch has been off or partially off:

    For less than 1 day, try to reapply it. If the patch does not stick completely, apply a new patch immediately. No backup contraception is needed and your “Patch Change Day” will stay the same.

    For more than 1 day or if you are not sure for how long, you could become pregnant. To reduce this chance, apply a new patch and start a new 4-week cycle. You will now have a new “Patch Change Day.” Use a non-hormonal backup contraception method, such as a condom and spermicide or diaphragm and spermicide, for the first week of your new 4-week patch cycle.

    If your patch becomes uncomfortable or your application site is red, painful or swollen:

    Change your patch. Remove your patch and apply a new patch to a new location until your next “Patch Change Day.”

    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.

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.

Important Safety Information

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:

  • If you are pregnant or think you are pregnant.
  • If you are scheduled for surgery as Xulane may increase your risk of blood clots after surgery. You should stop using your Xulane patch at least 4 weeks before and through at least 2 weeks after surgery.
  • If you are scheduled for any laboratory tests as certain blood tests may be affected by Xulane.
  • If you have experienced yellowing of the skin or eyes caused by pregnancy or related to previous use of hormonal birth control.
  • Are breastfeeding or plan to breastfeed. Xulane may decrease the amount of milk you make, and a small amount of hormones from the Xulane patch may pass into your breast milk.

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.

IMPORTANT SAFETY INFORMATION  

MORE LESS

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® (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.

Important Safety Information

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:

  • If you are pregnant or think you are pregnant.
  • If you are scheduled for surgery as Xulane may increase your risk of blood clots after surgery. You should stop using your Xulane patch at least 4 weeks before and through at least 2 weeks after surgery.
  • If you are scheduled for any laboratory tests as certain blood tests may be affected by Xulane.
  • If you have experienced yellowing of the skin or eyes caused by pregnancy or related to previous use of hormonal birth control.
  • Are breastfeeding or plan to breastfeed. Xulane may decrease the amount of milk you make, and a small amount of hormones from the Xulane patch may pass into your breast milk.

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.

Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together with Xulane.

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.

SIZE UP XULANE >

*Not actual size.