Xulane

Aug 1, 2022

Generic name:  ethinyl estradiol and norelgestromin
Dosage form: transdermal patch
Drug class:  Contraceptives

What is Xulane?

Xulane is a  birth control patch  you wear on your skin to stop you getting pregnant. Xulane contains two hormones – an estrogen and progestin – which are absorbed through the skin. It prevents pregnancy by stopping your ovaries from ovulating and releasing eggs.

Xulane is a generic version of a patch called Ortho Evra, which has been discontinued.

What is Xulane used for?

Xulane is a birth control patch for women with a BMI less than 30 kg/m2. It is used to prevent pregnancy.

Your chances of getting pregnant while using Xulane depend on how well you follow the directions for using it. 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.

Xulane and other birth control patches are as effective at preventing pregnancy as birth control pills and vaginal rings with hormones. Birth control patches are more effective then condoms and diaphragms.

Important information

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.

Who should not use Xulane?

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.

What should I tell my doctor before using Xulane?

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.

How should I use Xulane?

  • For detailed instructions, see the step-by-step instructions for using Xulane below.
  • 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.
  • 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 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.

Dosage

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

Detailed Xulane dosage information

What are the side effects of Xulane?

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.

See “Important information” above.

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 likelihood of developing a serious blood clot for women who use hormonal birth control is between 3 and 12, for pregnant women is between 5 and 20, and for women in the first 12 weeks after delivering a baby (postpartum) is between 40 and 65.

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.

Does hormonal birth control cause cancer?

It is not known if hormonal birth control causes breast 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.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control 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.

Xulane side effects  (more detail)

Interactions

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.

Xulane drug interactions  (more detail)

Pregnancy and breastfeeding

Xulane is not known to cause birth defects when used by accident during pregnancy.

Tell your doctor if you 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.

Storage

  • 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.

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.

Xulane is manufactured for Mylan Pharmaceuticals Inc, Morgantown, WV 26505 USA.

Instructions for use for Xulane

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

  • 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 oral hormone birth control pills, a vaginal contraceptive ring or another contraceptive transdermal patch to the Xulane 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 contraception.
    • 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 contraceptive transdermal patch, use a non-hormonal contraceptive method, such as a condom and spermicide or diaphragm and spermicide, 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.

Step 1. Choose a place on your body for your Xulane patch

  • 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

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

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