Norelgestromin/Ethinyl Estradiol, Transdermal

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KEY POINTS

• This medicine is a patch applied to the skin to prevent pregnancy. Use it exactly as directed.
• Keep all appointments for checkups to see how this medicine affects you.
• This medicine may increase your risk for heart attack, stroke, and blood clots. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: contraceptive (birth control)

Generic and brand names: norelgestromin/ethinyl estradiol, transdermal; Ortho Evra; Xulane

What is this medicine used for?

This medicine is a patch applied to the skin to prevent pregnancy. It is a combination of a progestin and estrogen, two female hormones.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergy to any hormones or medicines
• A stroke or transient ischemic attack (TIA)
• Blood clots in your legs, lungs, or eyes
• Cancer of the breast, uterus, cervix, or vagina
• Depression
• Diabetes
• Heart attack or stroke
• Heart disease or a heart attack
• High blood pressure
• High cholesterol
• Liver, gallbladder, or kidney disease
• Migraines or headaches along with vomiting, double vision, unsteadiness, weakness, or personality changes
• Seizures
• Thyroid problems
• Unexplained vaginal bleeding or irregular menstrual periods
• Yellowing of the eyes or skin (jaundice) during pregnancy or during past use of hormonal birth control

Tell your healthcare provider if you have recently had or are scheduled to have a long period of bed rest after major surgery or a broken bone in a cast.

Tell your healthcare provider if you smoke. Smoking while you are using this medicine increases the risk of serious side effects such as heart attack, stroke, and blood clots. The risk increases with age and the number of cigarettes smoked a day. Talk to your healthcare provider about ways to quit smoking.

Females of childbearing age: Do not use this product if you are pregnant, think you may be pregnant, or are breast-feeding because it may harm the baby. Stop taking this medicine at the first sign you may be pregnant and contact your healthcare provider right away.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as prescribed by your healthcare provider on the schedule prescribed. Read the detailed patient information sheet that comes in the medicine package for more information.

Check with your healthcare provider before using this medicine in children who have not reached puberty.

The patch is a weekly form of birth control. You will change your patch once a week for 3 weeks in a row. You will not wear a patch during the fourth week.

Apply the patch on the same day of the week each week. This is your "patch change day". For example, if the first patch is applied on Monday, apply future patches on Monday of each of the 3 weeks in a cycle. Wear only 1 patch at a time.

After 1 week without a patch (week 4), you start a new 4-week cycle by applying a new patch. Never go for more than 7 days without a patch or you will not be protected from getting pregnant.

You can decide with your healthcare provider when to start wearing the patch. This could be either on the first day of your period, or on the first Sunday after your period starts.

If you are starting on the first day of your period, you must apply the first patch during the first 24 hours of your menstrual period. If you start after day 1 of your menstrual period, you need to use another kind of birth control, such as condoms or a diaphragm, for the first 7 days that you wear the patch.

For a Sunday start, apply the first patch on the first Sunday after your period starts. Use another kind of birth control such as condoms or a diaphragm for the first 7 days that you wear the patch.

You can wear your patch on the buttocks, abdomen, upper body (front or back, except the breasts), or upper outer arm. Do not apply the patch on skin that is red, irritated, or cut. Do not apply the patch to your breasts. You can wear it in a different place each week to avoid irritation. Do not wear it under tight clothing. Do not cut or tear the patch.

Do not put make-up, creams, lotions, powders, or other products on the skin where you wear a patch.

If a patch comes off, try to put it back on the same spot, or replace it with a new patch right away. No back-up birth control is needed. Your patch change day will stay the same.

Do not reapply a patch if:

• It is no longer sticky.
• It has becomes stuck to itself or another surface.
• It has another material stuck to it.
• It has become loose or fallen off more than once.

If you cannot reapply the same patch, apply a new patch right away. Do not use tape, bandages, or wraps to hold a patch in place.

If the patch comes off and stays off for more than 24 hours, or you are not sure how long the patch has been off, you may not be protected against pregnancy. You must start a new patch cycle by applying a new patch. This will be a new day 1 and a new patch change day. You must use a back-up method of birth control for the first week of the new cycle.

Check with your healthcare provider if you:

• Forget to change a patch
• Wish to change your patch change day
• Are switching from birth control pills, rings, or shots
• Are using the patch after childbirth
• Are using the patch after an abortion or miscarriage
• Are having bleeding or spotting between periods
• Have problems with skin irritation
• Miss a menstrual period

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

Hormones from patches put on the skin get into the blood stream. You will be exposed to more estrogen if you use this medicine than if you use a birth control pill. Increased estrogen exposure may increase the risk of side effects, including blood clots. Talk with your provider about this.

See your healthcare provider at least once a year for checkups while you are receiving this medicine. Keep all appointments.

If you need any lab tests, tell your healthcare provider you are using the patch. Birth control hormones may change some blood test results. If you need an MRI, remove the patch before the test. The patch may interfere with the MRI.

This product does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

If you wear contact lenses your vision might change. You may not be able to wear contact lenses. Talk to your healthcare provider about this.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using birth control hormones. You may have a greater risk of blood clots. The patch may need to be removed before certain tests or procedures such as MRIs.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.):

• Allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing)
• Sharp chest pain, coughing blood, or sudden shortness of breath
• Sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking

Serious (Report these to your healthcare provider right away.):

• Yellowing of the skin or eyes, especially with fever, tiredness, loss of appetite, dark urine, or light-colored bowel movements
• Pain, redness, or swelling in the calf
• Severe pain, swelling, or tenderness in the abdomen
• Breast lumps or tenderness
• Irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days
• Swelling of your hands or ankles
• Trouble sleeping, weakness, lack of energy, fatigue, or depression
• Vision changes or trouble wearing contact lenses

Other: Vaginal or urinary infection, vaginal discharge or itching, weight gain, headache, nausea, vomiting, bloating, dizziness, abnormal taste, acne, diarrhea, mood swings, darkening of skin on the face, skin irritation where you apply the patch.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Acetaminophen and medicines that contain acetaminophen
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), flurazepam, and triazolam (Halcion)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin)
• Antidepressants such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), nefazodone, and nortriptyline (Pamelor)
• Antifungal medicines such as fluconazole (Diflucan), griseofulvin (Grifulvin V, Gris-PEG), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ethotoin (Peganone), felbamate (Felbatol), fosphenytoin (Cerebyx), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend)
• Artemether/lumefantrine (Coartem)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac) and verapamil (Calan, Covera, Verelan)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), lovastatin (Altoprev), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Corticosteroids such as cortisone, dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Dantrolene (Dantrium)
• Diabetes medicines such as acarbose (Precose), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Doxepin (Silenor)
• Enzalutamide (Xtandi)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat breathing or lung problems such as aminophylline and theophylline
• Morphine (Kadian, MS Contin)
• Natural remedies such as black cohosh, chasteberry, dong quai, evening primrose oil, ginseng, red clover, soy, St. John's wort, topical progesterone, and wild yam
• Retinoid medicines such as acitretin (Soriatane), bexarotene (Targretin), isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane), and tretinoin (Atralin, Renova, Retin-A)
• Selegiline (Eldepryl, Emsam, Zelapar)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Tizanidine (Zanaflex)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Do not place in refrigerator or freezer. Keep the patches tightly sealed until ready to use. Protect them from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.