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Mirabegron

    Brands

    DEA Class;  Rx

    Common Brand Names; Myrbetriq, Myrbetriq Granules

    • Beta3 Agonists

    Oral beta-3 adrenoreceptor agonist
    Used for overactive bladder (OAB) in adults as monotherapy or in combination with bladder-specific antimuscarinics and for neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older
    May increase blood pressure; do not use in patients with severe uncontrolled hypertension

    Indicated for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency

    Indicated in combination with the muscarinic antagonist solifenacin succinate for treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency

    Indicated for neurogenic detrusor overactivity (NDO) in children aged 3 years and older

    Hypersensitivity

    Adults

    • Elevated BP occurring predominantly in patients with preexisting hypertension (7.5-11.5%)

    Children aged 3-17 years

    • Urinary tract infection (24.4%)

    1-10%

    Adults

    • Monotherapy
      • Dry mouth (3-9%)
      • Urinary tract infection (UTI) (2.9-4.2%)
      • Nasopharyngitis (3.5-3.9%)
      • Headache (2.1-3.2%)
      • Back pain (2.8%)
      • Sinusitis (2.7%)
      • Arthralgia (1.3-2.1%)
      • Cystitis (2.1%)
      • Dizziness (2%)
      • Constipation (1.6%)
      • Tachycardia (1.2-1.6%)
      • Diarrhea (1.2-1.5%)
      • Fatigue (1.2-1.4%)
      • Reports of neoplasms (0-1%)
    • Combination with solifenacin
      • Dry mouth (7.2-9.3%)
      • UTI (4-8.4%)
      • Constipation (3.9-4.2%)
      • Tachycardia (0.9-2.2%)
      • Dyspepsia (1.1-1.3%)
      • Dizziness (0.4-1.3%)
      • Blurred vision (0.7-1.1%)
      • Arthralgia (0.5-1.1%)

    Angioedema of the face, lips, tongue, and/or larynx reported; may occur after the first dose or following multiple doses; promptly discontinue and initiate appropriate therapy to ensure a patent airway

    Increased blood pressure

    • May increase blood pressure (BP); monitor BP periodically, especially in hypertensive patients
    • Not recommended for use in severe uncontrolled hypertensive patients (ie, systolic BP ≥180 mm Hg and/or diastolic BP ≥110 mm Hg for adults; systolic and/or diastolic BP >99th percentile plus 5 mm Hg for age, sex, and stature for children)
    • BP increases may be larger in children aged 3 to <12 years compared with adolescents

    There are no studies with the use in pregnant women to inform drug-associated risk for birth defects or miscarriage

    There is no information on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production

    Adults

    Overactive Bladder

    Monotherapy

    25 mg PO qDay

    25 mg dose is typically effective within 8 weeks

    May increase to 50 mg PO qDay based on individual efficacy and tolerability

    Combination with muscarinic antagonist

    Combination regimen: 25 mg PO qDay plus solifenacin succinate 5 mg PO qDay

    May increase mirabegron to 50 mg PO qDay after 4-8 weeks based on individual efficacy and tolerability

    Pediatric

    <3 years: Safety and efficacy not established

    Aged ≥3 years, weight <35 kg

    • Granules for oral suspension

      • 11 kg to <22 kg: 24 mg (3 mL) PO qDay initially; may increase to maximum of 48 mg/day (6 mL)
      • 22 kg to <35 kg: 32 mg (4 mL) PO qDay initially; may increase to maximum of 64 mg/day (8 mL)

    Aged ≥3 years, weight ≥35 kg

    • Tablets: 25 mg PO qDay initially; may increase to maximum of 50 mg/day after 4-8 weeks
    • Granules for oral suspension: 48 mg (6 mL) PO qDay initially; may increase to maximum of 80 mg/day (10 mL) after 4-8 weeks

    Mirabegron

    tablet, extended-release

    • 25mg (Myrbetriq, generic)
    • 50mg (Myrbetriq, generic)