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XulaneCOm

Not actual patient.
Patch drawn to scale.

USING XULANE

You have choices on where to apply XULANE. It may be placed on clean, dry skin on the upper outer arm, abdomen, buttock or back.

Check your patch every day to make sure all edges are sticking securely to the skin for it to work properly.

Not actual patient.
Patch drawn to scale.

Click here to see the step-by-step instructions for using XULANE.

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.

Steps to 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. XULANE should be placed where it won’t be rubbed by tight clothing like under your bra strap or waistband of clothing. It should not be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.

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

Applying XULANE

Product Application How-to
*Not actual size.

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.

Product Application How-to
*Not actual size.

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

Product Application How-to
*Not actual size.

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.

Product Application How-to
*Not actual size.

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. XULANE must stick securely to your skin to work properly.

Check your patch every day to make sure all edges are sticking correctly.

Do’s

  • Apply the XULANE patch only to skin that is clean, dry, and free of any powder, make-up, cream, oil, or lotion.
  • Apply XULANE patch immediately upon removal from the protective pouch.
  • Apply a single patch the same day every week except for week 4, your Patch Free Week.
  • Remove your old patch before applying your new patch.
  • Check your patch every day to make sure all edges are sticking correctly.
  • 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.
  • Store your patch at room temperature between 20° to 25°C (68 to 77° F). Do not store in the refrigerator or freezer.

Don'ts

  • Do not apply the patch to your breasts.
  • Do not apply the XULANE patch to cut or irritated skin, or in the same location as the previous XULANE patch.
  • Do not try to reapply a XULANE 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.
  • Do not cut, damage, or alter the XULANE patch in any way.
  • Do not skip using any patches, even if you do not have sex often.
  • 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.
  • Do not allow your patch to be off for 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.

Getting started on XULANE

Select the situation that applies to you

Not currently using hormonal birth control

You have 2 ways to begin using your XULANE patch. Choose the way that is best for you:

First day start: Apply your first XULANE patch during the first 24 hours of your menstrual period.

Sunday start: Apply your first XULANE 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 XULANE patch that day, and no back-up birth control is needed.

Changing from another type of hormonal birth control or patch

Complete your current oral hormone birth control pill cycle, vaginal ring cycle or contraceptive transdermal patch cycle. Apply your first XULANE patch on the day you would normally start your next oral birth control pill, patch or insert your next vaginal ring.

If you do not get your period within 1 week after taking your last active pill, removing your last vaginal ring or contraceptive transdermal patch, check with your healthcare provider to make sure you are not pregnant. You may still go ahead and start XULANE for birth control.

If you apply your XULANE patch more than 1 week after taking your last active oral hormone birth control pill, removing your last vaginal ring or birth control transdermal patch, use a birth control contraceptive method, such as a condom and spermicide or diaphragm and spermicide, with the XULANE patch for the first 7 days of patch use.

Starting XULANE after childbirth

If you are not breastfeeding, wait 4 weeks before using XULANE 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 XULANE.

Starting XULANE after a miscarriage or abortion

You may start XULANE immediately after a miscarriage or abortion that occurs in the first 12 weeks (first trimester) of pregnancy. You do not need to use another birth control.

If you do not start XULANE 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 have 2 ways to begin using your XULANE patch. Choose the way that is best for you:

First day start: Apply your first XULANE patch during the first 24 hours of your menstrual period.

Sunday start: Apply your first XULANE 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 XULANE patch that day, and no back-up birth control is needed.

If you are starting XULANE after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using XULANE 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 XULANE.

Scroll for Important Safety Information

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 kg/m2 or more; liver disease or liver tumors; unexplained vaginal bleeding; have had 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>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.

Does hormonal birth control cause cancer?

It is not known if hormonal birth control causes cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

Women who use hormonal birth control methods may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What is XULANE?

XULANE is a prescription birth control patch for women with a BMI<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.

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.