What is Xulane?

Cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with the number of cigarettes smoked and is marked in women over 35 years of age. Women who are over 35 years of age and smoke should not use ethinyl estradiol/norelgestromin. A significantly increased risk of venous thromboembolism was found among women aged 15 to 44 years who used ethinyl estradiol/norelgestromin patch compared with oral contraceptives containing 30 to 35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate. Increased estrogen exposure from the patch may increase the risk of adverse events, including venous thromboembolism, compared with oral contraceptives .

Norelgestromin and ethinyl estradiol combination contraceptive skin patch is used to prevent pregnancy. Hormones from the patch are absorbed through your skin into your body. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

This patch allows more estrogen into the blood than oral birth control containing the same amount of estrogen.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. Discuss with your doctor your options for birth control.

Norelgestromin and ethinyl Estradiol combination does not prevent AIDS or other sexually transmitted diseases. It will not prevent hepatitis B. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have questions.

This transdermal patch system is to be used for 28 days (four-week) cycle. A new patch is applied each week for 3 weeks (21 days), and week four is patch-free.

When you begin using norelgestromin and ethinyl estradiol combination transdermal, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condoms, spermicides, diaphragms) for the first 7 days of your first patch cycle.

To use this patch:

• Keep each patch in the package until you are ready to use it.
• Wash your hands with soap and water before and after applying a patch.
• Apply the patch to clean, dry, and intact skin on the abdomen or stomach, upper body, the upper outside part of the arm, or the buttocks. Avoid touching the sticky surface of the patch.
• Make sure there is no lotion, powder, cream, or make-up on the skin.
• Apply the patch and then press it with the palm of your hand for 10 seconds to make sure it sticks.
• Change the location of the patch each time you apply a new one. Do not apply a patch to skin that is injured, broken, or cut. Do not apply a patch to your breasts. Check the patch every day to make sure it is in place.

If the patch comes off partly or all the way, try to apply it again or apply a new patch. If it becomes loose less than 24 hours, no other form of birth control is needed. If the patch has peeled away for more than 24 hours, apply a new patch and start a new cycle. A second form of birth control should also be used.

If the patch is not sticky or has stuck to material or itself, remove it and apply a new patch. Do not hold the patch in place with tape or wraps.

If you are switching from a contraceptive pill or vaginal ring to using the patch, start the patch on the first day of your period for Ortho Evra® or on the day that you would usually use your next pill or vaginal ring for Xulane®. If your period does not start after 5 days for Ortho Evra® or 1 week for Xulane®, you should see your doctor for a pregnancy test. If you start the patch later than the first day of your period for Ortho Evra® or if you apply Xulane® more than 1 week after using your last pill or vaginal ring, use a second method of birth control with the patch for the first 7 days.

If you have a miscarriage or an abortion in the first trimester of your pregnancy, you may start norelgestromin and ethinyl estradiol combination transdermal right away. You do not need a second form of birth control. If you start this medicine 5 days or more after the miscarriage or abortion, you should use a second form of birth control with the patch for the first 24 hours during the start of your menstrual period or for the first 7 days on the first Sunday of your menstruation. If you have a miscarriage or abortion after the first trimester, you should wait for 4 weeks before starting this medicine.

If you use this patch after giving birth and choose not to breastfeed, you may start after 4 weeks to prevent the risk of having blood clots.

If you have bleeding with the patch in place, continue to use the patches as usual. If the bleeding continues for 2–3 cycles, call your doctor. If you do not have your period during the time the patch is off, stay on your regular schedule and call your doctor.

If the patch is uncomfortable or causes irritation, change to a new patch in a new location. Change the patch again on your regular schedule. Do not use more than one patch at a time.

When you remove a patch, carefully fold it in half so that it sticks to itself and throw it away. There will still be some hormones on the patch. Do not touch the inside of the patch.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may begin your patch on the first day of your menstrual period (called Day-1 start) or on a Sunday (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you forget to change a patch. Do not change your schedule on your own. If the schedule that you have been put on is not convenient, talk to your doctor about changing schedules.

• For transdermal dosage form (skin patch):
  • For contraception (to prevent pregnancy):
    • Adults—Apply one patch to the skin and keep it in place for 1 week. Apply a new patch at the beginning of week 2 and again at week 3. Always change the patch on the same day of the week. Do not use a patch during week 4. This is when you will have your period. Start a new patch 7 days after the last patch was removed.
    • Children—Use and dose must be determined by your doctor.

Call your doctor or pharmacist for instructions.

Follow your doctor's orders or the directions on the label if you forget to change your patch. This includes only some of the ways to handle this medicine. Your doctor may want you to stop using this medicine and use other birth control methods for the rest of the month until you have your menstrual period. Then your doctor can tell you how to begin using your medicine again.

If you forget to apply your patch during the 1st week, apply it as soon as possible and start a new cycle. Use a second form of birth control for the first week of the new cycle. You will now have a new patch start day.

If you forget to change your patch in the 2nd or 3rd week for one or two days, change it as soon as you remember. No other form of birth control is needed. If you forget to change your patch in the 2nd or 3rd week for more than two days, change to a new patch and start a new cycle. Use a second form of birth control for the first week of the new cycle. If you forget to remove your patch at the end of the 3rd week, remove it as soon as possible and then start a new patch on your regular start day. You should never have the patch off for more than 7 days in a row.

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold the patch in half with the sticky sides together. Place it in a child-resistant container or a sealed bag. Make sure to dispose of it out of the reach of children and pets.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies on the relationship of age to the effects of norelgestromin and ethinyl estradiol combination transdermal have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Appropriate studies on the relationship of age to the effects of norelgestromin and ethinyl estradiol combination transdermal have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anagrelide
• Aprepitant
• Boceprevir
• Bosentan
• Bupropion
• Carbamazepine
• Ceritinib
• Dabrafenib
• Darunavir
• Dexamethasone
• Donepezil
• Encorafenib
• Enzalutamide
• Fosaprepitant
• Fosphenytoin
• Glecaprevir
• Griseofulvin
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Nafcillin
• Nevirapine
• Oxcarbazepine
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenobarbital
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisone
• Primidone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Amprenavir
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Colesevelam
• Cyclosporine
• Efavirenz
• Eslicarbazepine Acetate
• Etoricoxib
• Fosamprenavir
• Ginseng
• Lamotrigine
• Levothyroxine
• Licorice
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Parecoxib
• Prednisolone
• Rifapentine
• Ritonavir
• Roflumilast
• Rufinamide
• Selegiline
• Telaprevir
• Tipranavir
• Troglitazone
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, or history of or
• Cervical cancer, or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), now or in the past or
• Hypertension (high blood pressure), uncontrolled or
• Liver disease, including tumors or cancer or
• Major surgery with a long period of inactivity or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Depression, history of or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Edema (fluid retention or body swelling) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Obesity—Use of the transdermal patch may be less effective in women with body weight greater than or equal to 198 pounds (90 kilograms).

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while using this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine.

Norelgestromin and ethinyl estradiol transdermal may not work as well for you if you weigh more than 198 pounds (98 kilograms). Talk to your doctor about the kind of birth control that is best for you.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when light, or breakthrough bleeding when heavier. If this should occur:

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been using hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

This medicine will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begin to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.

Check with your doctor if you miss a menstrual period so that the cause may be determined. Missed periods may occur if you have not used the patch exactly as scheduled or the medicine is not the right strength or type for your needs. You might need a pregnancy test.

If you suspect that you may have become pregnant, stop using this medicine immediately and check with your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using this birth control, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about the type of diet and exercise to control your weight and blood cholesterol level.

You will be exposed to more estrogen if you use this medicine than if you use a typical birth control pill. Increased estrogen exposure may increase the risk of side effects. Talk to your doctor about this risk.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Using this medicine may increase your risk of breast cancer or cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if you experience abnormal vaginal bleeding.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine may increase your risk for gallbladder disease. Talk with your doctor about this risk.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Use with caution around small children. The contraceptive patch may be a choking hazard if swallowed by a child.

Make sure any doctor who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.