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.

Dosing Information

The recommended starting dose of Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily [see Clinical Studies].

Myrbetriq should be taken with water, swallowed whole and should not be chewed, divided, or crushed.

Dose Adjustments in Specific Populations

The daily dose of Myrbetriq should not exceed 25 mg once daily in the following populations:

• Patients with severe renal impairment (CLcr 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m²) [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
• Patients with moderate hepatic impairment (Child-Pugh Class B) [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Myrbetriq is not recommended for use in patients with end stage renal disease (ESRD), or in patients with severe hepatic impairment (Child-Pugh Class C) [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Dosage Forms And Strengths

Myrbetriq extended-release tablets are supplied in two different strengths as described below:

• 25 mg oval, brown, film coated tablet, debossed with the (Astellas logo) and “325”
• 50 mg oval, yellow, film coated tablet, debossed with the (Astellas logo) and “355”

Storage And Handling

Myrbetriq is supplied as oval, film coated extended-release tablets, available in bottles and blister units as follows

Store at 25°C (77°) with excursions permitted from 15°C to 30°C (59°F to 86°). {see USP controlled Room Temperature}

Manufactured by: Astellas Pharma Technologies, Inc., Norman, Oklahoma 73072. Marketed and Distributed by: Astellas Pharma US, Inc., Northbrook, Illinois 60062. Revised: September 2012

Last reviewed on RxList: 3/25/2013
This monograph has been modified to include the generic and brand name in many instances.