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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MYRBETRIQTM safely and effectively. See full prescribing information for MYRBETRIQ. MYRBETRIQTM (mirabegron) extended-release tablets, for oral use Initial U.S. Approval: 2012 INDICATIONS AND USAGE Myrbetriq is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency (1) DOSAGE AND ADMINISTRATION Recommended starting dose is 25 mg once daily, with or without food (2.1) 25 mg is effective within 8 weeks. Based on individual efficacy and tolerability, may increase dose to 50 mg once daily (2.1, 14) Swallow whole with water, do not chew, divide or crush (2.1) ● Patients with Severe Renal Impairment or Patients with Moderate Hepatic Impairment: Maximum dose is 25 mg once daily (2.2, 8.6, 8.7, 12.3) Patients with End Stage Renal Disease (ESRD) or Patients with Severe Hepatic Impairment: Not recommended (2.2, 8.6, 8.7, 12.3) DOSAGE FORMS AND STRENGTHS Extended-release tablets: 25 mg and 50 mg (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Increases in Blood Pressure: Myrbetriq can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Myrbetriq is not recommended for use in severe uncontrolled hypertensive patients (5.1). Urinary Retention in Patients With Bladder Outlet Obstruction and in Patients Taking Antimuscarinic Drugs for Overactive Bladder: Administer with caution in these patients because of risk of urinary retention (5.2). Patients Taking Drugs Metabolized by CYP2D6: Myrbetriq is a moderate inhibitor of CYP2D6. Appropriate monitoring is recommended and dose adjustment may be necessary for narrow therapeutic index CYP2D6 substrates (5.3, 7.1, 12.3) ADVERSE REACTIONS Most commonly reported adverse reactions ( 2% and placebo) were hypertension