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Select Product Brochure New 02 Select Product Catalog Mylan offers an expansive and growing portfolio to help OB-GYNs manage the unique health concerns of their patients at every stage of their lives. For more information about our extensive product offerings, please contact your Mylan Sales Representative, or visit Mylan.com. A comprehensive line of Not actual patients Contraceptives available from Mylan Click on the Mylan product name(s) for Full Prescribing Information, including Boxed WARNING(s). • Risk of liver enzyme elevations with concomitant hepatitis sex hormone-binding globulin and cortisol-binding globulin. The MYLAN PRODUCT NAME ROUTE OF ADMINISTRATION/ MYLAN NDC/ STRENGTH C treatment: ALT elevations greater than 5 times the upper limit dose of replacement thyroid hormone or cortisol therapy may DOSAGE FORM PACK SIZE of normal (ULN), were significantly more frequent in women using need to be increased. (5.13) ethinyl estradiol medications. Discontinue Xulane prior to starting TRANSDERMAL CONTRACEPTIVE • Monitoring: A woman who is taking hormonal contraceptive therapy [(See Contraindication (4)]. Xulane can be restarted should have a yearly visit with her healthcare provider for a blood approximately 2 weeks after hepatitis C combination drug regimen BW Transdermal 0378-3340-53 150 mcg/35 mcg pressure check and for other indicated healthcare. (5.14) (norelgestromin/ethinyl estradiol Extended Release Film 3 systems per day ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. (5.4)] • Hereditary Angioedema: In women with hereditary angioedema, transdermal system) • High blood pressure: Do not prescribe Xulane for women with exogenous estrogens may induce or exacerbate symptoms of uncontrolled hypertension or hypertension with vascular angioedema. (5.15) disease. (5.5) BW Boxed Warning – This drug has a boxed warning. • Chloasma: Chloasma may occasionally occur, especially in • Gallbladder Disease: Studies suggest a small increased relative women with a history of chloasma gravidarum. Women with a risk of developing gallbladder disease among CHC users. (5.6) INDICATION AND USAGE norelgestromin and ethinyl estradiol transdermal system tendency of chloasma should avoid exposure to the sun or compared with women using oral contraceptives containing 30 Xulane® is indicated for the prevention of pregnancy in women who • Carbohydrate and lipid metabolic effects: Monitor prediabetic ultraviolet radiation while using Xulane. (5.16) mcg to 35 mcg of EE. Increased estrogen exposure may increase and diabetic women taking Xulane. Consider an alternate elect to use a transdermal patch as a method of contraception. ADVERSE REACTIONS the risk of adverse events, including VTE. contraceptive method for women with uncontrolled Limitation of Use: Xulane may be less effective in preventing dyslipidemia. (5.7) The most frequent adverse reactions reported during clinical trials pregnancy in women at or above 198 lbs (90 kg). (≥ 5%) were breast symptoms, nausea/vomiting, headache, CONTRAINDICATIONS • Headache: Evaluate significant change in headaches and SELECTED IMPORTANT RISK HIGHLIGHTS OF PRESCRIBING application site disorder, abdominal pain, dysmenorrhea, vaginal Do not prescribe Xulane to women who are known to have the discontinue Xulane if indicated. (5.8) INFORMATION: These selected highlights do not include all the bleeding and menstrual disorders, and mood, affect and anxiety following conditions: information needed to use XULANE safely and effectively. See the • Uterine bleeding: Evaluate irregular bleeding or amenorrhea. (5.9) disorders. (6.1) full Prescribing Information for XULANE. • A high risk of arterial or venous thrombotic diseases. Examples • Hormonal Contraceptive Use Before or During Early DRUG INTERACTIONS include women who are known to: Pregnancy: Discontinue Xulane if pregnancy is confirmed. NUMBERS IN THE PARENTHESES INDICATE RESPECTIVE SECTIONS IN THE FULL Drugs or herbal products that induce certain enzymes (for example PRESCRIBING INFORMATION. o Smoke, if over age 35 Administration of CHCs should not be used as a test for o Have deep vein thrombosis or pulmonary embolism, CYP3A4) may decrease the effectiveness of CHCs or increase WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH pregnancy. (5.10) now or in the past breakthrough bleeding. Counsel patients to use a back-up or SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND o Have inherited or acquired hypercoagulopathies • Depression: Carefully observe women with a history of depression alternative method of contraception when enzyme inducers are used PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL o Have cerebrovascular disease and discontinue Xulane if depression recurs to a serious degree. with CHCs. (7.1) (5.11) Cigarette Smoking and Serious Cardiovascular Risks o Have coronary artery disease Do not co-administer Xulane with HCV drug combinations containing Cigarette smoking increases the risk of serious cardiovascular o Have thrombogenic valvular or thrombogenic rhythm diseases • Carcinoma of Breasts and Cervix: Xulane is contraindicated in ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to events from hormonal contraceptive use. This risk increases with of the heart (for example, subacute bacterial endocarditis with women who currently have or have had breast cancer because potential for ALT elevations. (7.3) age, particularly in women over 35 years of age, and with the valvular disease, or atrial fibrillation) breast cancer may be hormonally sensitive. (5.12) [See Use In Specific Populations number of cigarettes smoked. For this reason, hormonal o Have uncontrolled hypertension Contraindications (4)]. contraceptives, including Xulane, should not be used by women o Have diabetes mellitus with vascular disease • Nursing mothers: Not recommended; can decrease milk • Effect on Binding Globulins: The estrogen component of CHCs who are over 35 years of age and smoke. o Have headaches with focal neurological symptoms or have production. (8.3) migraine headaches with aura may raise the serum concentrations of thyroxine-binding globulin, Risk of Venous Thromboembolism • Women over age 35 with any migraine headaches The risk of venous thromboembolism (VTE) among women aged • Liver tumors, benign or malignant, or liver disease 15 to 44 who used the norelgestromin and ethinyl estradiol • Undiagnosed abnormal uterine bleeding transdermal system compared to women who used several • Pregnancy, because there is no reason to use hormonal different oral contraceptives was assessed in five U.S. contraceptives during pregnancy epidemiologic studies using electronic healthcare claims data. • Breast cancer or other estrogen- or progestin-sensitive cancer, The relative risk estimates ranged from 1.2 to 2.2; one of the now or in the past studies found a statistically significant increased relative risk of • Do not prescribe Xulane to women using Hepatitis C drug VTE for current users of norelgestromin and ethinyl estradiol combinations containing ombitasvir/paritaprevir/ritonavir, with or transdermal system. without dasabuvir, due to the potential for ALT elevations Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE) WARNINGS AND PRECAUTIONS The PK profile for norelgestromin and ethinyl estradiol transdermal system is different from the PK profile for oral • Vascular risks: Stop Xulane if a thrombotic event occurs. Stop at contraceptives in that it has a higher steady state concentration least 4 weeks before and through 2 weeks after major surgery. and a lower peak concentration. Area under the Start no earlier than 4 weeks after delivery, in women who are not time-concentration curve (AUC) and average concentration at breastfeeding. (5.1) steady state (C ) for EE are approximately 60% higher in women ss • PK Profile: AUC and average Css for EE are approximately 60% using norelgestromin and ethinyl estradiol transdermal system higher in women using norelgestromin and ethinyl estradiol compared with women using an oral contraceptive containing 35 transdermal system compared with women using an oral mcg of EE. In contrast, the peak concentration (C ) for EE is max contraceptive containing 35 mcg [See Boxed WARNING and approximately 25% lower in women using norelgestromin and Clinical Pharmacology (12.3) found in Full Prescribing Information.] ethinyl estradiol transdermal system. It is not known whether there are changes in the risk of serious adverse events based on • Liver Disease: Discontinue Xulane if jaundice occurs. (5.3) the differences in PK profiles of EE in women using 2 A comprehensive line of Not actual patients Contraceptives available from Mylan Important Safety Information (Cont’d) • Risk of liver enzyme elevations with concomitant hepatitis sex hormone-binding globulin and cortisol-binding globulin. The C treatment: ALT elevations greater than 5 times the upper limit dose of replacement thyroid hormone or cortisol therapy may of normal (ULN), were significantly more frequent in women using need to be increased. (5.13) ethinyl estradiol medications. Discontinue Xulane prior to starting • Monitoring: A woman who is taking hormonal contraceptive therapy [(See Contraindication (4)]. Xulane can be restarted should have a yearly visit with her healthcare provider for a blood approximately 2 weeks after hepatitis C combination drug regimen pressure check and for other indicated healthcare. (5.14) ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. (5.4)] • Hereditary Angioedema: In women with hereditary angioedema, • High blood pressure: Do not prescribe Xulane for women with exogenous
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