Mirabegron

3
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)
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