XULANE (Page 8 of 9)

Drug Interactions

In a PK drug interaction study, oral administration of tetracycline HCl, 500 mg four times daily for 3 days prior to and 7 days during wear of norelgestromin and ethinyl estradiol transdermal system did not significantly affect the PK of NGMN or EE.

Use in Specific Populations

Effects of Age, Body Weight, Body Surface Area and Race

The effects of age, body weight, body surface area and race on the PK of NGMN and EE were evaluated in 230 healthy women from nine pharmacokinetic studies of single 7-day applications of norelgestromin and ethinyl estradiol transdermal system. For both NGMN and EE, increasing age, body weight and body surface area each were associated with slight decreases in Css and AUC values. However, only a small fraction (10% to 25%) of the overall variability in the PK of NGMN and EE following application of norelgestromin and ethinyl estradiol transdermal system may be associated with any or all of the above demographic parameters. There was no significant effect of race with respect to Caucasians, Hispanics and Blacks.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

See Warnings and Precautions (5.3, 5.12) and Use in Specific Populations (8.1).

Norelgestromin was tested in in vitro mutagenicity assays (bacterial plate incorporation mutation assay, CHO/HGPRT mutation assay, chromosomal aberration assay using cultured human peripheral lymphocytes) and in one in vivo test (rat micronucleus assay) and found to have no genotoxic potential.

14 CLINICAL STUDIES

In 3 large clinical trials lasting 12 months, in North America, Europe and South Africa, 3,330 women (ages 18 to 45) completed 22,155 cycles of norelgestromin and ethinyl estradiol transdermal system use, the pregnancy rate in women aged 18 to 35 years was 1.07 (95% confidence interval 0.60, 1.76) per 100 woman-years of norelgestromin and ethinyl estradiol transdermal system use. The racial distribution was 91% Caucasian, 4.9% Black, 1.6% Asian, and 2.4% Other.

With respect to weight, 5 of the 15 pregnancies reported with norelgestromin and ethinyl estradiol transdermal system use were among women with a baseline body weight ≥ 198 lbs., which constituted < 3% of the study population. The greater proportion of pregnancies among women at or above 198 lbs. was statistically significant and suggests that norelgestromin and ethinyl estradiol transdermal system may be less effective in these women.

Patch Adhesion

In the clinical trials with norelgestromin and ethinyl estradiol transdermal system, approximately 2% of the cumulative number of patches completely detached and 3% partially detached. The proportion of subjects with at least one patch that completely detached ranged from 2% to 6%, with a reduction from Cycle 1 (6%) to Cycle 13 (2%). For instructions on how to manage detachment of patches, refer to Dosage and Administration (2).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Xulane® (norelgestromin and ethinyl estradiol transdermal system) is available in one strength of 150 mcg/day NGMN and 35 mcg/day EE.

Xulane® is a 14 cm² peach, transdermal system printed with “Xulane® (norelgestromin and ethinyl estradiol) 150/35 mcg per day” in brown ink. Each system contains 4.86 mg norelgestromin, USP and 0.53 mg ethinyl estradiol, USP.

Each transdermal system is packaged in a protective pouch.

Xulane® (norelgestromin and ethinyl estradiol transdermal system) is available in folding cartons of one cycle each (NDC 0378-3340-53); each cycle contains 3 systems.

16.2 Special Precautions for Storage and Disposal

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Store patches in their protective pouches. Apply immediately upon removal from the protective pouch.

Do not store in the refrigerator or freezer.

Used patches still contain some active hormones. The sticky sides of the patch should be folded together and the folded patch placed in a sturdy container, preferably with a child-resistant cap, and the container thrown in the trash. Used patches should not be flushed down the toilet.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

17.1 General

Counsel patients about the following information:

Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive use, and that women who are over 35 years old and smoke should not use combined hormonal contraceptives.
The use of CHCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of CHCs. The risk of VTE in women using CHCs is 3 to 12 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to CHCs gradually disappears after use is discontinued.
Xulane does not protect against HIV infection (AIDS) and other sexually transmitted infections.
The Warnings and Precautions associated with combined hormonal contraceptives.
Xulane is not to be used during pregnancy; if pregnancy occurs during use of Xulane, instruct the patient to stop further use.
Apply a single patch the same day every week (Weeks 1 through 3). Instruct patients what to do in the event a patch is missed. See “WHAT IF I FORGET TO CHANGE MY PATCH?” section in FDA-Approved Patient Labeling.
Use a back-up or alternative method of contraception when enzyme inducers are used with Xulane.
Combined hormonal contraceptives may reduce breast milk production; this is less likely to occur if breastfeeding is well established.
Women who start combined hormonal contraceptives postpartum, and who have not yet had a period, should use an additional method of contraception until they have used a patch for 7 consecutive days.
Amenorrhea may occur. Consider pregnancy in the event of amenorrhea. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles, amenorrhea in one cycle if the woman has not adhered to the dosing schedule, or if associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness.
If the Xulane patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs.
A patch should not be re-applied if it is no longer sticky, becomes stuck to itself or another surface, has other material stuck to it, or has become loose or fallen off before. If a patch cannot be re-applied, a new patch should be applied immediately. Supplemental adhesives or wraps should not be used.
A woman may not be protected from pregnancy if a patch is partially or completely detached for ≥ 24 hours (or if the woman is not sure how long the patch has been detached). She should start a new cycle immediately by applying a new patch. Back-up contraception, such as a condom and spermicide or diaphragm and spermicide, must be used for the first week of the new cycle.

The brands listed are trademarks of their respective owners.

PATIENT INFORMATION

XULANE® [zhoo’ lane]

(norelgestromin and ethinyl estradiol transdermal system)

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.

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.

What is XULANE?

XULANE is a 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.

How well does XULANE work?

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.

In clinical studies, 1 to 2 out of 100 women got pregnant during the first year that they used the norelgestromin and ethinyl estradiol transdermal system.

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.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Chance of Getting Pregnant
(click image for full-size original)

Do not use XULANE if you:

smoke and are over 35 years old
have or have had blood clots in your arms, legs, eyes or lungs
have an inherited problem that makes your blood clot more than normal
have had a stroke
have had a heart attack
have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart
have high blood pressure that medicine cannot control
have diabetes with kidney, eye, nerve, or blood vessel damage
have had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over age 35
have a BMI of 30 or more
have liver disease, including liver tumors, take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.
have unexplained vaginal bleeding
are pregnant or think you may be pregnant. However, XULANE is not known to cause birth defects when used by accident during pregnancy.
have had breast cancer or any cancer that is sensitive to female hormones

Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control.

Tell your healthcare provider if you have ever had any of the above conditions. Your healthcare provider may recommend another method of birth control.

Before you use XULANE tell your healthcare provider:

about all your medical conditions
if you are pregnant or think you are pregnant
if you are scheduled for surgery. XULANE may increase your risk of blood clots after surgery. You should stop using your XULANE patch at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery.
if you are scheduled for any laboratory tests. Certain blood tests may be affected by hormonal birth control methods.
are breastfeeding or plan to breastfeed. Hormonal birth control methods that contain estrogen, like XULANE, may decrease the amount of milk you make. A small amount of hormones from the XULANE patch may pass into your breast milk. Consider another method of birth control until you are ready to stop breastfeeding.

Tell your healthcare provider about all medicines and herbal products that you take.

Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:

certain seizure medicines (carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, and topiramate)
aprepitant
barbiturates
bosentan
griseofulvin
certain combinations of HIV medicines (nelfinavir, ritonavir, ritonavir-boosted protease inhibitors)
certain non-nucleoside reverse transcriptase inhibitors (nevirapine)
rifampin and rifabutin
St. John’s wort

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, including:

acetaminophen
ascorbic acid
medicines that affect how your liver breaks down other medicines (itraconazole, ketoconazole, voriconazole, and fluconazole)
certain HIV medicines (atazanavir, indinavir)
atorvastatin
rosuvastatin
etravirine

Hormonal birth control methods may interact with lamotrigine, an anti-seizure medicine used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

Women on thyroid replacement therapy may need increased doses of thyroid hormone.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use XULANE?

For detailed instructions, see the step-by-step instructions for using XULANE at the end of this Patient Information.
Use XULANE exactly as your healthcare provider tells you to use it.
Wear 1 XULANE patch at a time. Make sure you remove your old XULANE patch before applying your new XULANE patch.
Do not skip using any XULANE patches, even if you do not have sex often.
XULANE is applied in a 4-week cycle.
Apply your XULANE patch 1 time each week for 3 weeks (21 total days).
Apply each new XULANE patch on the same day of the week. This day will be your “Patch Change Day.” For example, if you apply your first XULANE patch on a Monday, all of your XULANE patches should be applied on a Monday.
Do not apply your XULANE patch during Week 4. Make sure you remove your old XULANE 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 XULANE patch on the day after Week 4 ends. Repeat the cycle of 3 weekly applications followed by a patch-free week.
Patch Calendar
(click image for full-size original)
Your XULANE patch should never be off for more than 7 days in a row. If your XULANE 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 1 period and have not used your XULANE patch every day or you miss 2 periods in a row.

What are the possible side effects of XULANE?

See “What is the most important information I should know about XULANE?”

XULANE may cause serious side effects, including:

blood clots. Like pregnancy, hormonal birth control methods increase the risk of serious blood clots (see following graph), especially in women who have other risk factors such as smoking, high blood pressure, high levels of fat in the blood, diabetes, obesity, a family history of blood clots, or age greater than 35. This increased risk is highest when you first start using hormonal birth control and when you restart the same or different hormonal birth control after not using it for 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 provider about your risk of getting a blood clot before using XULANE or deciding which type of birth control is right for you.
It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:
legs (deep vein thrombosis)
lungs (pulmonary embolus)
eyes (loss of eyesight)
heart (heart attack)
brain (stroke)

To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use hormonal birth control are followed for one year, between 1 and 5 of these women will develop a blood clot. The figure below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use hormonal birth control, for women who use hormonal birth control, for pregnant women, and for women in the first 12 weeks after delivering a baby.

Likelihood of Developing a Serious Blood Clot (Venous Thromboembolism [VTE])

Likelihood of Developing a Serious Blood Clot (Venous Thromboembolism [VTE])
(click image for full-size original)

Call your healthcare provider 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

The most common side effects of XULANE are:

breast symptoms (discomfort, swelling, or pain)
nausea
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
mood, affect and anxiety disorders

Some women have spotting or light bleeding, breast tenderness, or feel sick to their stomach during norelgestromin and ethinyl estradiol transdermal system use. If these symptoms occur, do not stop using the XULANE patch. The problem will usually go away. If it does not go away, check with your healthcare provider.

Less common side effects are:

acne
less sexual desire
bloating or fluid retention
blotchy darkening of your skin, especially your face
high blood sugar, especially in women with diabetes
high fat (cholesterol, triglycerides) levels in the blood
depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
problems tolerating contact lenses
weight gain

Tell your healthcare provider 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 provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store and throw away used XULANE patches?

Store at room temperature between 20°C to 25°C (68°F to 77°F).
Do not store XULANE patches outside of their pouches. Apply immediately upon removal from the protective pouch.
Do not store in the refrigerator or freezer.
Used XULANE patches still contain some active hormones. To throw away the XULANE patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Do not flush used XULANE patches down the toilet.
Return unused, unneeded, or expired patches to your pharmacist.

Keep XULANE and all medicines out of the reach of children.

General information about the safe and effective use of XULANE.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information. Do not use XULANE for a condition for which it was not prescribed. Do not give XULANE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XULANE that is written for health professionals.

For more information, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in XULANE?

Active ingredient: norelgestromin and ethinyl estradiol

Inactive ingredient: crospovidone, dipropylene glycol, fluoropolymer coated polyester film, light mineral oil, non-woven polyester fabric, oleyl alcohol, polyethylene/polyester film and polyisobutene adhesive. Each patch is printed with brown ink.

Do hormonal birth control methods cause cancer?

Hormonal birth control methods do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use hormonal birth control methods because some breast cancers are sensitive to hormones.

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 should I know about my period when using XULANE?

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 the patch for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue using the patch 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.

What if I miss my scheduled period when using XULANE?

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.

What if I want to become pregnant?

You may stop using XULANE whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop using the patch.

Instructions for Use
XULANE® [zhoo’ lane]
(norelgestromin and ethinyl estradiol transdermal system)

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:
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 changing from the pill or vaginal contraceptive ring to the XULANE patch:
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.
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.
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:
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:
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.
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.

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 Step 1
(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 Step 2 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 throw away the additional pieces of film above and below the XULANE patch, being careful not to separate the patch from the clear plastic cover.
Instructions for Use Step 2 Figure 2
Peel away half of the clear plastic. Avoid touching the sticky surface with your fingers.
Instructions for Use Step 2 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 Step 2 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:
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.
If your XULANE patch does not stick completely, remove it and apply a new XULANE patch.
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:
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.
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.
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:
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.
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.
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:
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.
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: 4/2020
NEETS:R15/PL:NEETS:R14

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