MIRABEGRON TAB,SA
Clinical Criteria Summary
Exclusion Criteria
- Urinary incontinence due to stress or stress-predominant incontinence
- Severe hepatic impairment (Child-Pugh Class C)
- End-stage renal disease (CrCl/eGFR < 15 ml/min or receiving hemodialysis)
- Systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg
Inclusion Criteria
- History of overactive bladder (OAB), either urge or mixed type
- At least one of the following must be fulfilled:
- Documented history of mental status changes with anticholinergic medication
- 12-week trials with 2 formulary anticholinergic/antimuscarinic OAB drugs OR one formulary and one nonformulary anticholinergic/antimuscarinic OAB drug resulting in treatment failure or intolerable adverse effects
- Diagnosis of Alzheimer’s disease or other dementia, cognitive impairment, gastric retention, xerostomia, uncontrolled narrow-angle glaucoma, or other condition for which an anticholinergic drug is contraindicated or could be harmful