The Food and Drug Administration (FDA) has approved changes to the Myrbetriq (mirabegron; Astellas Pharma) label to include a new contraindication and a new update to the Warnings and Precautions section.
The new label now includes a contraindication for patients who have known hypersensitivity reactions to mirabegron or any component of the tablet. Also, the label includes a warning regarding angioedema of the face, lips, tongue, and/or larynx. There have been reports of angioedema occurring after the first dose, hours after the first dose, and after multiple doses. If there is involvement of the tongue, hypopharynx, or larynx, Myrbetriq should be promptly discontinued and appropriate measures to ensure a patent airway should be initiated.
Myrbetriq is a beta-3 adrenergic receptor agonist approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. It is available as 25mg and 50mg strength extended-release tablets in 30- and 90-count bottles.
For more information call (800) 727-7003 or visit Myrbetriq.com.