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):

How to Apply Xulane

CHOOSING A PLACE ON THE BODY TO PUT THE PATCH

•

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.

•

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:

•

The woman should make sure the skin is clean and dry.

•

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

	• The woman should tear open the pouch at the top edge and one side edge. She should peel open the foil pouch. She should gently remove the contents of the foil pouch and discard the additional pieces of film above and below the patch.
	• The woman should peel away half of the clear plastic. She should avoid touching the sticky surface with her fingers.
	• The woman should apply the sticky side of the patch on the skin she has cleaned and dried. She should then remove the other half of the clear plastic and attach the entire patch to her skin.
	• The woman should press 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 outer edges of the patch.

•

The woman should check her patch every day to make sure all edges are sticking correctly.

WHEN TO CHANGE THE XULANE PATCH

•

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.

•

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.)

•

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:

•

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.

•

If her patch does not stick completely, she should remove it and apply a replacement patch.

•

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:

•

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).

•

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

•

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.

•

in the middle of the patch cycle (Week 2/Day 8 or Week 3/Day 15),

-

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.

-

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.

•

at the end of the patch cycle (Week 4/Day 22),

-

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.