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Xulane Generic Name & Formulations
Legal Class
Rx
General Description
Norelgestromin 150mcg/day, ethinyl estradiol 35mcg/day; transdermal patch.
Pharmacological Class
Progestin + estrogen.
How Supplied
Patches—3
Manufacturer
Xulane Indications
Indications
Transdermal contraception.
Limitations of Use
May be less effective in patients ≥90kg (198lbs).
Xulane Dosage and Administration
Adult
Apply to abdomen, buttock, upper outer arm, or back; with each new patch, rotate application site (may use same anatomic area). Apply 1 patch once weekly for 3 weeks, then 1 patch-free week; repeat.
Children
Premenarchal: not applicable.
Xulane Contraindications
Contraindications
High risk for arterial or venous thrombotic events (eg, smokers or migraineurs over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Undiagnosed abnormal uterine bleeding. Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic disease or tumors. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Xulane Boxed Warnings
Boxed Warning
Cardiovascular risk associated with smoking. Risk of venous thromboembolism. Pharmacokinetic profile of ethinyl estradiol.
Xulane Warnings/Precautions
Warnings/Precautions
Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Higher estrogen exposure than oral contraceptives (may increase adverse events risk). Gallbladder disease. Uncontrolled dyslipidemia. Hypertriglyceridemia; increased risk of pancreatitis. Diabetes. Obesity. Depression. Hereditary angioedema. Cholasma gravidarum. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Do regular complete physical exams. Use barrier contraception with Sunday starts or postpartum starts (see full labeling). Nursing mothers: not recommended.
Xulane Pharmacokinetics
See Literature
Xulane Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Xulane prior to starting HCV regimen and restart 2wks after completion. Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's Wort, barbiturates, bosentan, carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate), possibly others. May antagonize lamotrigine; consider dosage adjustment. May be affected by HIV protease inhibitors, NNRTIs. May be potentiated by acetaminophen, ascorbic acid, atorvastatin, rosuvastatin, and CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice). May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May antagonize acetaminophen, clofibric acid, morphine, salicyclic acid, temazepam. May affect measurement of clotting factors, thyroid binding globulin, sex hormone binding globulin, lipids, glucose, other serum binding proteins.
Xulane Adverse Reactions
Adverse Reactions
Breast symptoms, nausea, vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding, menstrual disorders, mood, affect, and anxiety disorders; hypertension, amenorrhea, oligomenorrhea, transient delay of ovulation after discontinuation, edema, possible venous thromboembolism; others (see full labeling).
Xulane Clinical Trials
See Literature
Xulane Note
Not Applicable
Xulane Patient Counseling
See Literature
