Mirabegron

What it is and how it works

Mechanism of Action Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity. Although mirabegron showed very low intrinsic activity for cloned human beta-1 AR and beta-2 AR, results in humans indicate that beta-1 AR stimulation occurred at a mirabegron dose of 200 mg.

Mechanism class: Adrenergic beta3-Agonists · Cytochrome P450 2D6 Inhibitors · Cytochrome P450 3A Inhibitors

Indications

Mirabegron extended-release tablets are a beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. Adult Overactive Bladder (OAB) Mirabegron Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron extended-release tablets are indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.

Dosage and administration (summary)

Mirabegron extended-release tablets and Mirabegron Granules are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (Mirabegron extended-release tablets and Mirabegron Granules) based on the indication and patient's weight. OAB in Adults The recommended starting dose of mirabegron extended-release tablets is 25 mg orally once daily. After 4 to 8 weeks, the mirabegron extended-release tablets dose may be increased to 50 mg orally once daily.

Contraindications

Mirabegron extended-release tablets are contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet . Hypersensitivity to mirabegron or any inactive ingredients.

Warnings and precautions

Increases in Blood Pressure: Can increase blood pressure in adult or pediatric patients. Periodically monitor blood pressure, especially in hypertensive patients. Mirabegron extended-release tablets are not recommended in patients with severe uncontrolled hypertension. Urinary Retention in Patients with Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Drugs for Overactive Bladder: Administer with caution in these patients because of risk of urinary retention. Angioedema: Angioedema of the face, lips, tongue and/or larynx has been reported with mirabegron.

Pregnancy

Pregnancy Risk Summary There are no studies with the use of mirabegron in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes.

Storage and supply

Mirabegron extended-release tablets Mirabegron extended-release tablets, 25mg are peach colored, oval shaped, biconvex, film-coated tablets debossed with "1159" on one side and plain on other side and are supplied as follows: NDC 70710-1159-3 in bottles of 30 tablets with child-resistant closure NDC 70710-1159-9 in bottles of 90 tablets with child-…

Source: Mirabegron (Mirabegron) — US FDA prescribing information, 2024-10-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.