Drug Detail:Mirabegron (Mirabegron [ mir-a-beg-ron ])
Drug Class: Urinary antispasmodics
Usual Adult Dose for Urinary Incontinence
Monotherapy:
Initial dose: 25 mg orally once a day
Maintenance dose: 25 to 50 mg orally once a day based on individual patient efficacy and tolerability
Combination therapy with solifenacin (muscarinic antagonist)
Initial dose: 25 mg orally once a day plus solifenacin 5 mg orally once a day
- After 4 to 8 weeks, may increase mirabegron to 50 mg per day based on individual patient efficacy and tolerability
Comments:
- Adults dosage for the granules has not been determined.
- The tablet and the granules formulation are not substitutable on a milligram-per-milligram basis.
- In clinical trials, mirabegron 25 mg was effective within 8 weeks, while the 50 mg dose showed efficacy within 4 weeks.
- In a clinical trial with combination mirabegron and solifenacin, combination therapy demonstrated greater improvements from baseline compared either drug alone; improvements were demonstrated at 3 months and maintained throughout the 1-year trial.
Uses: As monotherapy or in combination with a muscarinic antagonist (solifenacin) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
Usual Adult Dose for Urinary Frequency
Monotherapy:
Initial dose: 25 mg orally once a day
Maintenance dose: 25 to 50 mg orally once a day based on individual patient efficacy and tolerability
Combination therapy with solifenacin (muscarinic antagonist)
Initial dose: 25 mg orally once a day plus solifenacin 5 mg orally once a day
- After 4 to 8 weeks, may increase mirabegron to 50 mg per day based on individual patient efficacy and tolerability
Comments:
- Adults dosage for the granules has not been determined.
- The tablet and the granules formulation are not substitutable on a milligram-per-milligram basis.
- In clinical trials, mirabegron 25 mg was effective within 8 weeks, while the 50 mg dose showed efficacy within 4 weeks.
- In a clinical trial with combination mirabegron and solifenacin, combination therapy demonstrated greater improvements from baseline compared either drug alone; improvements were demonstrated at 3 months and maintained throughout the 1-year trial.
Uses: As monotherapy or in combination with a muscarinic antagonist (solifenacin) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
Usual Adult Dose for Overactive Bladder Syndrome
Monotherapy:
Initial dose: 25 mg orally once a day
Maintenance dose: 25 to 50 mg orally once a day based on individual patient efficacy and tolerability
Combination therapy with solifenacin (muscarinic antagonist)
Initial dose: 25 mg orally once a day plus solifenacin 5 mg orally once a day
- After 4 to 8 weeks, may increase mirabegron to 50 mg per day based on individual patient efficacy and tolerability
Comments:
- Adults dosage for the granules has not been determined.
- The tablet and the granules formulation are not substitutable on a milligram-per-milligram basis.
- In clinical trials, mirabegron 25 mg was effective within 8 weeks, while the 50 mg dose showed efficacy within 4 weeks.
- In a clinical trial with combination mirabegron and solifenacin, combination therapy demonstrated greater improvements from baseline compared either drug alone; improvements were demonstrated at 3 months and maintained throughout the 1-year trial.
Uses: As monotherapy or in combination with a muscarinic antagonist (solifenacin) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
Usual Pediatric Dose for Bladder Muscle Dysfunction - Overactive
Pediatric Patients weighing less than 35 kg (Granules):
Starting Dose:
- For 11 kg to less than 22 kg: 3 mL (24 mg)
- Maximum Dose: 6 mL (48 mg)
- For 22 kg to less than 35 kg: 4 mL (32 mg)
- Maximum Dose: 8 mL (64 mg)
Pediatric Patients weighing 35 kg or more (Tablets or Granules):
Tablets:
Initial dose: 25 mg orally once a day
Maintenance dose: After 4 to 8 weeks, may increase to 50 mg orally once a day based on individual patient efficacy and tolerability
Granules:
Initial dose: 6 mL (48 mg) orally once
Maintenance dose: After 4 to 8 weeks, may increase to 10 mL (80 mg) orally once a day based on individual patient efficacy and tolerability
Comments:
- The granules recommended dosages are determined based on patients' weight.
- The tablet and the granules formulations are not substitutable on a milligram-per-milligram basis.
- Do not combine the tablets with the granules to achieve the total dose.
- It is recommended to assess patients periodically for potential dosage adjustment.
Use:
- Tablets: For the treatment of neurogenic detrusor overactivity in pediatric patients aged 3 years and older and weighing 35 kg or more
- Granules: For the treatment of neurogenic detrusor overactivity in pediatric patients aged 3 years and older
Renal Dose Adjustments
Adults:
- Mild or moderate renal dysfunction [Estimated glomerular filtration rate (eGFR) 30 to 89 mL/min/1.73 m2]: No adjustment recommended
- Severe renal dysfunction (eGFR 15 to 29 mL/min/1.73 m2): 25 mg orally once a day
- End-Stage renal dysfunction (eGFR less than 15 mL/min/1.73 m2 or undergoing hemodialysis): Not recommended
Pediatrics:
Pediatric Patients Aged 3 Years or Older Weighing Less Than 35 kg:
- Mild or moderate renal dysfunction (eGFR 30 to 89 mL/min/1.73 m2): No adjustment recommended
- Severe renal dysfunction (eGFR 15 to 29 mL/min/1.73 m2):
22 kg to less than 35 kg 4 mL (32 mg): 4 mL (32 mg) orally once a day
- End-Stage renal dysfunction (eGFR less than 15 mL/min/1.73 m2 or undergoing hemodialysis): Not recommended
Pediatric Patients Aged 3 Years or Older Weighing 35 kg or more:
Tablets:
- Mild or moderate renal dysfunction (eGFR 30 to 89 mL/min/1.73 m2): No adjustment recommended
- Severe renal dysfunction (eGFR 15 to 29 mL/min/1.73 m2): 25 mg orally once a day
- End-Stage renal dysfunction (eGFR less than 15 mL/min/1.73 m2 or undergoing hemodialysis): Not recommended
Granules:
- Mild or moderate renal dysfunction (eGFR 30 to 89 mL/min/1.73 m2): No adjustment recommended
- Severe renal dysfunction (eGFR 15 to 29 mL/min/1.73 m2): 6 mL (48 mg) orally once a day
- End-Stage renal dysfunction (eGFR less than 15 mL/min/1.73 m2 or undergoing hemodialysis): Not recommended
Liver Dose Adjustments
Adults:
- Mild liver dysfunction (Child-Pugh A): No adjustment recommended
- Moderate liver dysfunction (Child-Pugh B): 25 mg orally once a day
- Severe liver dysfunction (Child-Pugh C): Not recommended
Pediatrics:
Pediatric Patients Aged 3 Years or Older Weighing Less Than 35 kg:
- Mild liver dysfunction (Child-Pugh A): No adjustment recommended
- Moderate liver dysfunction (Child-Pugh B):
22 kg to less than 35 kg 4 mL (32 mg): 4 mL (32 mg) orally once a day
- Severe liver dysfunction (Child-Pugh C): Not recommended
Pediatric Patients Aged 3 Years or Older Weighing 35 kg or more:
Tablets:
- Mild liver dysfunction (Child-Pugh A): No adjustment recommended
- Moderate liver dysfunction (Child-Pugh B): 25 mg orally once a day
- Severe liver dysfunction (Child-Pugh C): Not recommended
Granules:
- Mild liver dysfunction (Child-Pugh A): No adjustment recommended
- Moderate liver dysfunction (Child-Pugh B): 6 mL (48 mg)
- Severe liver dysfunction (Child-Pugh C): Not recommended
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to the active substance or any product excipients
Safety and efficacy have not been established in patients younger than 3 years.
Consult WARNINGS section for additional precautions.
Dialysis
Hemodialysis: Not recommended
Peritoneal dialysis: Data not available
Other Comments
Administration advice:
- Adults may take the tablets orally with or without food and swallow whole with water; do not chew, divide, or crush
- Pediatric patients should take the tablets and reconstituted granules formulation with food to reduce potential exposure-related risks, such as increased heart rate
- Pediatrics patients should take the reconstituted granules formulation within 1 hour after preparation and not save the dose for later
- Shake the reconstituted granules formulation for 1 minute each day if the suspension is not used for 2 or more days
- When the suspension is ready to use, shake the bottle vigorously for 1 minute then let it stand until the foam on top of the suspension is gone (approximately 1 to 2 minutes)
- If you miss a dose, take the missed dose as soon as possible. Skip that dose if more than 12 hours have passed and resume with the next scheduled dose; do not take 2 doses on the same day
Storage requirements:
- Tablets: 20°C to 25°C (68°F to 77°F); excursions 15°C to 30°C (59°F to 86°F)
- Granules: 20°C to 25°C (68°F to 77°F); excursions 15°C to 30°C (59°F to 86°F)
- Reconstituted suspension: 20°C to 25°C (68°F to 77°F) for up to 28 days. Discard unused portion after 28 days
Reconstitution/preparation techniques: The manufacturer product information should be consulted.
Monitor:
- Periodic blood pressure measurements, especially in patients with hypertension
- Monitor for urinary retention
- Monitor for angioedema
Patient advice:
- Read the US approved Patient Information.
- Patients should be advised to contact their healthcare provider if they have a high blood pressure reading if they are unable to empty their bladder or experiencing angioedema.
- Pediatric patients and/or their caregivers should be advised to use an appropriate measuring device for measuring the correct dose.
- Pediatrics patients should take the reconstituted granules formulation within 1 hour after preparation and not save the dose for later.
- Shake the reconstituted granules formulation for 1 minute each day if the suspension is not used for 2 or more days
- When the suspension is ready to use, shake the bottle vigorously for 1 minute then let it stand until the foam on top of the suspension is gone (approximately 1 to 2 minutes)
- If you miss a dose, take the missed dose as soon as possible. Skip that dose if more than 12 hours have passed and resume with the next scheduled dose; do not take 2 doses on the same day
