What is the dosing for Myrbetriq (mirabegron)?

From the Guidelines

Myrbetriq (mirabegron) should be initiated at a dose of 25 mg once daily for adults with overactive bladder, and may be increased to 50 mg once daily after 8 weeks if needed for better symptom control, as supported by the 2019 AUA/SUFU guideline amendment 1. The medication should be taken with water and can be taken with or without food.

• For patients with severe kidney impairment (eGFR 15-29 mL/min) or moderate liver impairment, the maximum recommended dose is 25 mg daily.
• Myrbetriq is not recommended for patients with end-stage renal disease or severe hepatic impairment. The medication works by relaxing the detrusor muscle in the bladder by activating beta-3 adrenergic receptors, which increases bladder capacity and reduces symptoms like urgency, frequency, and urge incontinence, as shown in a randomized double-blind, active-controlled phase 3 study [@99@]. Patients should swallow the tablet whole without crushing or chewing it.
• Common side effects include increased blood pressure, urinary tract infection, and headache.
• Blood pressure should be monitored regularly while taking this medication, especially in patients with hypertension, as noted in a study analyzing the cardiovascular safety of mirabegron [@98@]. It is essential to consider the potential benefits and risks of mirabegron, including its efficacy and safety in combination with other medications, such as solifenacin, as evaluated in the BESIDE trial 1.
• The SYNERGY II trial also demonstrated the safety and efficacy of combination therapy with solifenacin and mirabegron over 12 months 1. Overall, the dosing of Myrbetriq should be individualized based on the patient's response and tolerability, with consideration of the latest evidence and guidelines, such as the 2023 European Association of Urology guidelines on the management of non-neurogenic male lower urinary tract symptoms 4.

From the FDA Drug Label

2.2 Recommended Dosage for Adult Patients with OAB Mirabegron Monotherapy The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to the maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks. 2.3 Recommended Dosage for Pediatric Patients Aged 3 Years and Older with NDO For pediatric patients 3 years of age and older, select the appropriate product (Mirabegron extended-release tablets and Mirabegron Granules) based on the patient's weight Pediatric Patients weighing 35 kg or more: Use mirabegron extended-release tablets The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to a maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks.

The recommended dosing for Myrbetriq (mirabegron) is as follows:

• Adult patients with OAB: 25 mg orally once daily, increasing to 50 mg orally once daily after 4 to 8 weeks if needed.
• Pediatric patients aged 3 years and older with NDO weighing 35 kg or more: 25 mg orally once daily, increasing to 50 mg orally once daily after 4 to 8 weeks if needed. 5

From the Research

Myrbetriq Dosing

• Myrbetriq, also known as mirabegron, is a medication used to treat overactive bladder (OAB) symptoms 6, 7, 8, 9, 10.
• The recommended dosing for Myrbetriq is 25mg or 50mg once daily 7, 8, 9.
• Studies have shown that mirabegron 50mg is as efficacious as antimuscarinics in reducing the frequency of micturition, incontinence, and urgency urinary incontinence (UUI) episodes 6, 9.
• Mirabegron has a favorable safety and tolerability profile, particularly compared with antimuscarinics, with a lower incidence of dry mouth, constipation, and central nervous system effects 6, 7, 8, 9, 10.

Efficacy and Tolerability

• Mirabegron 50mg has been shown to be significantly more efficacious than placebo for all efficacy endpoints, including micturition frequency, UUI, and dry rate 9.
• Combination treatment of solifenacin 5mg plus mirabegron 25 or 50mg appears to provide an efficacy benefit compared with mirabegron 50mg alone, but with more anticholinergic side effects 9.
• Mirabegron has a more favorable tolerability profile than antimuscarinics, with a lower incidence of anticholinergic adverse events, including dry mouth and constipation 6, 8, 9, 10.

Persistence and Adherence

• Studies have shown that persistence and adherence with mirabegron are statistically significantly greater than with tolterodine ER and other antimuscarinics prescribed for OAB 10.
• The median time-to-discontinuation was significantly longer for mirabegron compared to tolterodine ER and other antimuscarinics 10.
• The 12-mo persistence rates and medication possession ratio (MPR) were also significantly greater with mirabegron than with all the antimuscarinics 10.