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Follow all directions on your prescription label. Do not use more skin patches or wear them for longer than recommended by your doctor. You will apply your first patch on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).
Place the patch on your skin and press it into place firmly for 10 seconds. Make sure the edges stick well. You will wear the patch for a full week.
Apply the patch to clean, dry skin on any of these areas: the outside of your upper arm, your stomach, your buttocks, or your upper back. Do not apply the patch to skin that is broken or irritated, or to a skin area that may be rubbed by tight clothing (such as a waistband).
Remove the patch and apply a new one on the same day each week for three weeks in a row. At the end of the third week, remove the patch and do not apply a new one for 7 full days. Your period should start during this time Do not allow more than 7 days to pass before starting your next 3-week patch cycle..
Check your patch every day to make sure it is sticking well. If a patch comes loose or falls off, throw it away and apply a new one. You may need to use back-up birth control, such as condoms or a spermicide, if a patch has been off for more than 24 hours. Follow your doctor's instructions.
You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.
While using ethinyl estradiol and norelgestromin transdermal, you will need to visit your doctor regularly.
After removing a skin patch fold it in half, sticky side in, and throw it away in a place where children and pets cannot get to it. Do not flush a used patch down the toilet.
Store the skin patches at room temperature away from moisture and heat. Do not freeze or refrigerate. Keep each patch in its foil pouch until you are ready to apply it.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
If you forget to change your patch at the end of the week, change it as soon as you remember. If it has been 24 hours or longer since your scheduled patch change, apply a new patch and start the cycle over (3 weeks wearing a weekly patch,1 week off). Do not use extra patches to make up the missed dose.
Missing a dose increases your risk of becoming pregnant and you may need to use back-up birth control. Follow the weekly patch schedule closely.
Uses of Xulane
- It is used to prevent pregnancy.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Xulane?
- If you have an allergy to ethinyl estradiol, norelgestromin, or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer, diseased arteries in the brain, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, high cholesterol, a pancreas problem (pancreatitis) due to high blood triglycerides, liver disease, liver tumor, very bad headache or migraine, diabetes that affects blood flow, or tumor where estrogen makes it grow.
- If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
- If you have surgery and need bedrest.
- If you are pregnant or may be pregnant. Do not take Xulane if you are pregnant.
- If you are breast-feeding or plan to breast-feed.
- If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xulane with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some other side effects of Xulane?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Weight gain.
- Upset stomach or throwing up.
- Enlarged breasts.
- Breast soreness.
- Period (menstrual) changes. These include lots of bleeding, spotting, or bleeding between cycles.
- Lowered interest in sex.
- Skin irritation.
- This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Indications and Usage for Xulane
Xulane is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.
Limitation of Use:• Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Effects of Other Drugs on Combined Hormonal ContraceptivesSubstances Decreasing the Plasma Concentrations of CHCs and Potentially Diminishing the Efficacy of CHCs
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.Substances Increasing the Plasma Concentrations of CHCs
Co-administration of atorvastatin or rosuvastatin and certain CHCs containing EE increase AUC values for EE by approximately 20% to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritnoavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).
Effects of Combined Hormonal Contraceptives on Other Drugs
CHCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of CHCs [see Warnings and Precautions (5.13)].
Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation
Do not co-administer Xulane with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.4)].
Interference with Laboratory Tests
The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
Use in specific populations
There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose hormonal contraceptives prior to conception or during early pregnancy.
The administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
The effects of Xulane in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of contraceptive steroids and/or metabolites are present in breast milk.
Safety and efficacy of norelgestromin and ethinyl estradiol transdermal system have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
Xulane has not been studied in postmenopausal women and is not indicated in this population.
No studies with Xulane have been conducted in women with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptive use until markers of liver function return to normal and combined hormonal contraceptive causation has been excluded. [See Contraindications (4) and Warnings and Precautions (5.3).]
No studies with Xulane have been conducted in women with renal impairment.
Women with Weight ≥ 198 lbs (90 kg)
Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.
Xulane® [zhoo’ lane]
(norelgestromin and ethinyl estradiol transdermal system)
150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol
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.
Women 15 to 44 years of age who use Xulane may have an increased risk of blood clots compared to women who use certain 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, including blood clots.
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. 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 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.
Fewer than 1 pregnancy per 100 women in one year
|• Implants • Injections • Intrauterine devices • Sterilization|
|• Birth control pills • Skin patch • Vaginal rings with hormones|
|• Condoms • Diaphragm|
10 to 20 pregnancies per 100 women in one year
|• No sex during the most fertile days of the monthly cycle • Spermicide • Withdrawal|
85 or more pregnancies per 100 women in one year
|• No birth control|
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 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 healthcare provider 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. • 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 one 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. o Apply your Xulane patch 1 time each week for 3 weeks (21 total days). o 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. o 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. o 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 one period and have not used your Xulane patch every day or you miss two 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, obesity, 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])
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 doesn't 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° to 25°C (68° 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.
This leaflet summarizes the most important information about Xulane. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Xulane that is written for health professionals.
For more information, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
What are the ingredients in Xulane?
Active ingredient: norelgestromin and ethinyl estradiol
Inactive ingredient: polyethylene, polyester, polyisobutene adhesive, crospovidone, mineral oil, non-woven polyester fabric, oleyl alcohol, dipropylene glycol, and a polyester film with a fluoropolymer coating.
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.