XULANE (Page 10 of 11)

Instructions for Use

Xulane is for skin use only.

Do not cut, damage, or alter the Xulane patch in any way.

How to start using your Xulane patch:

Instructions for Use Figure A
If you are not currently using hormonal birth control, you have 2 ways to begin using your Xulane patch. Choose the way that is best for you:
o
First day start: Apply your first Xulane patch during the first 24 hours of your menstrual period.
o
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 changing from the pill or vaginal contraceptive ring to the Xulane patch:
o
Complete your current pill cycle or vaginal ring cycle. Apply your first Xulane patch on the day you would normally start your next pill or insert your next vaginal ring.
o
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 Xulane for contraception.
o
If you apply your Xulane 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 Xulane patch for the first 7 days of patch use.
If you are starting Xulane after childbirth:
o
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.
If you are starting Xulane after a miscarriage or abortion:
o
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 contraceptive method.
o
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.
o
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.

Figure B is a picture of the Xulane patch.

Instructions for Use Figure B
Step 1. Choose a place on your body for your Xulane patch
Instructions for Use Body Placement
(click image for full-size original)
The Xulane patch may be placed on your upper outer arm, abdomen, buttock or back in a place where it will not be rubbed by tight clothing. Avoid the waistline because clothing and belts may cause your patch to be rubbed off.
Do not apply the patch to your breasts.
Apply the Xulane patch only to skin that is clean, dry, and free of any powder, make-up, cream, oil, or lotion.
Do not apply the Xulane patch to cut or irritated skin, or in the same location as the previous Xulane patch.
Step 2: Apply your Xulane patch
Instructions for Use -- Patch Application Figure 1
Tear open the pouch at the top edge and one side edge. Peel open the foil pouch. Gently remove the contents of the foil pouch and discard the additional pieces of film above and below the Xulane patch.
Instructions for Use -- Patch Application Figure 2
Peel away half of the clear plastic. Avoid touching the sticky surface with your fingers.
Instructions for Use -- Patch Application Figure 3
Apply the sticky side of the Xulane patch to clean, dry skin. Remove the other half of the clear plastic and apply the entire patch to your skin.
Instructions for Use -- Patch Application Figure 4
Press firmly on the Xulane 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 Xulane patch.
Check your Xulane patch every day to make sure all edges are sticking correctly.

Step 3: Throwing away your Xulane patch

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.

Important notes:

Your Xulane patch must stick securely to your skin to work properly.
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.
If your Xulane patch edge lifts up:
o
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 Xulane patch.
o
If your Xulane patch does not stick completely, remove it and apply a new Xulane patch.
o
Do not tape or wrap the Xulane patch to your skin or reapply a Xulane patch that is partially stuck to clothing.
If your Xulane patch has been off or partially off:
o
For less than 1 Day, try to reapply it. If the Xulane patch does not stick completely, apply a new Xulane patch immediately. No back-up contraception is needed and your “Patch Change Day” will stay the same.
o
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 Xulane patch and start a new 4 week cycle. You will now have a new “Patch Change Day.” Use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first week of your new 4 week Xulane cycle.
If you want to move your “Patch Change Day” to a different day of the week, finish your current cycle. Remove your third Xulane patch on the correct day.
o
During week 4 , the “Patch Free Week” (Day 22 through Day 28), you may choose an earlier “Patch Change Day” by applying a new patch on the day you prefer. You now have a new Day 1 and a new “Patch Change Day.”
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.”
If you forget to change or remove your Xulane patch:
o
At the start of any patch cycle (Week 1, Day 1):
You could become pregnant. You must use a back-up contraception method for 7 days. Apply the first Xulane patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1.
o
In the middle of your patch cycle (Week 2 or Week 3):
If you forget to change your Xulane patch for 1 or 2 days, apply a new Xulane patch as soon as you remember. Apply your next patch on your normal “Patch Change Day.” No back-up contraception method is needed.
If you forget to change your Xulane 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 Xulane patch. You now have a different “Patch Change Day” and a new Day 1. You must use a back-up contraception method for the first 7 days of your new cycle.
o
At the end of your patch cycle (Week 4):
If you forget to remove your Xulane 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 back-up contraception method is needed.
If you forget to apply your Xulane patch at the start of your next patch cycle, you could become pregnant. Apply the first Xulane 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 back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first 7 days of your new 4 week Xulane cycle.
If you have trouble remembering to change your Xulane patch, talk to your healthcare provider about how to make patch changing easier or about using another method of contraception.
If you are not sure how to use your Xulane patch:
o
Use a back-up contraception method such as a condom and spermicide or diaphragm and spermicide anytime you have sex. Make sure to have one of these non-hormonal contraception methods ready at all times.
o
Talk to your healthcare provider for instructions on using your Xulane patch.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 4/2017
NEETS:R14

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