Mirabegron
Dosing in kidney impairment
Recommended Dosage in Pediatric Patients with Renal or Hepatic Impairment For pediatric patients 3 years of age and older, select the appropriate product (MYRBETRIQ or mirabegron for extended-release oral suspension) based on the patient’s weight. Pediatric Patients Weighing Less Than 35 kg with Renal or Hepatic Impairment: Use Mirabegron for Extended-Release Oral Suspension Dosage in Pediatric Patients with Renal Impairment The recommended dosage of mirabegron for extended-release oral suspension in pediatric patients with renal impairment (administered orally once daily) is described in Table 4 [see Use in Specific Populations].
For administration instructions, see Dosage and Administration. Table 4: Mirabegron for Extended-Release Oral Suspension Recommended Dosage in Pediatric Patients Aged 3 Years and Older Weighing Less Than 35 kg with Renal Impairment (Administered Orally Once Daily) [See table below.] 1. Estimate GFR using a validated eGFR estimating equation for the pediatric age range of the approved indication.
Dosage in Pediatric Patients with Hepatic Impairment The recommended dosage of mirabegron for extended-release oral suspension in pediatric patients with hepatic impairment (administered orally once daily) is described in Table 5 [see Use in Specific Populations] . For administration instructions, see Dosage and Administration.
Table 5: Mirabegron for Extended-Release Oral Suspension Recommended Dosage in Pediatric Patients Aged 3 Years and Older Weighing Less Than 35 kg with Hepatic Impairment (Administered Orally Once Daily) [See table below.] Pediatric Patients weighing 35 kg or more with renal or hepatic impairment: Use MYRBETRIQ or Mirabegron for Extended-Release Oral Suspension Dosage in Pediatric Patients with Renal Impairment The recommended dosage of mirabegron for extended-release oral suspension in pediatric patients with renal impairment weighing 35 kg or more (administered orally once daily) is described in Table 6 [see Use in Specific Populations] .
For administration instructions, see Dosage and Administration. Table 6: Mirabegron for Extended-Release Oral Suspension Recommended Dosage in Pediatric Patients Aged 3 Years and Older with Renal Impairment Weighing 35 kg or More (Administered Orally Once Daily) [See table below.] 1. Estimate GFR using a validated eGFR estimating equation for the pediatric age range of the approved indication.
Dosage in Pediatric Patients with Hepatic Impairment The recommended dosage of mirabegron for extended-release oral suspension in pediatric patients with hepatic impairment weighing 35 kg or more (administered orally once daily) is described in Table 7 [see Use in Specific Populations]. For administration instructions, see Dosage and Administration.
Table 7: Mirabegron for Extended-Release Oral Suspension Recommended Dosage in Pediatric Patients Aged 3 Years and Older with Hepatic Impairment Weighing 35 kg or More (Administered Orally Once Daily) [See table below.]
| Estimated GFR1 | Body Weight Range | Starting Dose | Maximum Dose |
| eGFR 30 to 89 mL/min/1.73 m2 | 11 kg to less than 22 kg | 3 mL (24 mg) | 6 mL (48 mg) |
| 22 kg to less than 35 kg | 4 mL (32 mg) | 8 mL (64 mg) | |
| eGFR 15 to 29 mL/min/1.73 m2 | 11 kg to less than 22 kg | 3 mL (24 mg) | 3 mL (24 mg) |
| 22 kg to less than 35 kg | 4 mL (32 mg) | 4 mL (32 mg) | |
| eGFR < 15 mL/min/1.73 m2 or undergoing dialysis | Use is Not Recommended | ||
| Estimated GFR1 | Starting Dose | Maximum Dose |
| eGFR 30 to 89 mL/min/1.73 m2 | 6 mL (48 mg) | 10 mL (80 mg) |
| eGFR 15 to 29 mL/min/1.73 m2 | 6 mL (48 mg) | 6 mL (48 mg) |
| eGFR < 15 mL/min/1.73 m2 or undergoing dialysis | Use is Not Recommended | |
Dosing in liver impairment
Hepatic Impairment Mirabegron have not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, is not recommended for use in this patient population. No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). In pediatric patients with moderate hepatic impairment (Child-Pugh Class B), the daily dose of mirabegron should not exceed the recommended starting dose [see Clinical Pharmacology] .
| Hepatic Impairment Classification | Body Weight Range | Starting Dose | Maximum Dose |
| Child-Pugh Class A (Mild hepatic impairment) | 11 kg to less than 22 kg | 3 mL (24 mg) | 6 mL (48 mg) |
| 22 kg to less than 35 kg | 4 mL (32 mg) | 8 mL (64 mg) | |
| Child-Pugh Class B (Moderate hepatic impairment) | 11 kg to less than 22 kg | 3 mL (24 mg) | 3 mL (24 mg) |
| 22 kg to less than 35 kg | 4 mL (32 mg) | 4 mL (32 mg) | |
| Child-Pugh Class C (Severe hepatic impairment) | Use is Not Recommended | ||
| Hepatic Impairment Classification | Starting Dose | Maximum Dose |
| Child-Pugh Class A (Mild hepatic impairment) | 6 mL (48 mg) | 10 mL (80 mg) |
| Child-Pugh Class B (Moderate hepatic impairment) | 6 mL (48 mg) | 6 mL (48 mg) |
| Child-Pugh Class C (Severe hepatic impairment) | Use is Not Recommended | |
Preparation and administration
Preparation and Storage Instructions for Mirabegron for Extended-Release Oral Suspension The required dose for mirabegron for extended-release oral suspension is calculated based on the weight of the patient. Prepare oral suspension at the time of dispensing. Keep the bottle in the pouch up until the time of reconstitution.
Discard the pouch and desiccant prior to reconstitution. Do not dispense. Tap the closed bottle several times to loosen the granules. Measure 100 mL of water, add the total amount to the bottle, and immediately shake vigorously for 1 minute, then let it stand for 10 to 30 minutes. Shake vigorously again for 1 minute. If granules have not dispersed, shake vigorously for another 1 minute.
Record the 28-day expiration date on the container and carton based on the reconstitution date. Give the patient an appropriate dosing device. Store the reconstituted suspension at 20°C to 25°C (68°F to 77°F) for up to 28 days. Discard the unused portion after 28 days [see How Supplied/Storage and Handling] . After reconstitution with 100 mL water, the suspension contains 8 mg/mL of mirabegron.
Administration Instructions Administration instructions for MYRBETRIQ and mirabegron for extended-release oral suspension differ based on the patient population. Mirabegron for Extended-Release Oral Suspension Adult patients: A recommended dosage for mirabegron for extended-release oral suspension for adults has not been determined.
Pediatric patients: Take mirabegron for extended-release oral suspension prepared as an extended-release oral suspension [see Dosage and Administration]. Take with food to reduce potential exposure-related risks [see Use in Specific Populations].
| Body Weight Range | Starting Dose | Maximum Volume |
| 11 kg to less than 22 kg | 3 mL (24 mg) | 6 mL (48 mg) |
| 22 kg to less than 35 kg | 4 mL (32 mg) | 8 mL (64 mg) |
| Greater than or equal to 35 kg | Refer to information in next section | |