Mirabegrondosage

2 DOSAGE & ADMINISTRATION MYRBETRIQ and mirabegron for extended-release oral suspension are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (MYRBETRIQ or mirabegron for extended-release oral suspension) based on the indication and patient’s weight. Do not combine MYRBETRIQ and mirabegron for extended-release oral suspension to achieve the total dose. A recommended dosage for mirabegron for extended-release oral suspension for adults has not been determined. NDO in Pediatric Patients 3 Years and Older Pediatric Patients weighing less than 35 kg: Use mirabegron for extended-release oral suspension: The recommended starting dose of mirabegron for extended-release oral suspension is weight-based and administered as an extended-release oral suspension once daily. After 4 to 8 weeks, increase to the lowest effective dose without exceeding the maximum recommended dose. Pediatric Patients weighing 35 kg or more: Use MYRBETRIQ or mirabegron for extended-release oral suspension: The recommended starting dosage of mirabegron for extended-release oral suspension, administered as an extended-release oral suspension, is 6 mL (48 mg) orally once daily. After 4 to 8 weeks, increase to a maximum dosage of mirabegron for extended-release oral suspension 10 mL (80 mg) orally once daily Pediatric Patients with Renal or Hepatic Impairment: Refer to the full prescribing information for recommended dosage. Preparation for Mirabegron for Extended-Release Oral Suspension: Refer to the full prescribing information. Administration Mirabegron for Extended-Release Oral Suspension: Pediatric patients: Take mirabegron for extended-release oral suspension prepared as an extended-release oral suspension. Take with food.

2.1 Important

Dosage Information MYRBETRIQ and mirabegron for extended-release oral suspension are two different products and they are not substitutable on a milligram-per-milligram basis: Select the recommended product (MYRBETRIQ or Mirabegron for extended-release oral suspension) based on the indication and patient’s weight. Do not combine MYRBETRIQ and mirabegron for extended-release oral suspension to achieve the total dose. A recommended dosage for mirabegron for extended-release oral suspension for adults has not been determined.

2.3 Recommended

Dosage for Pediatric Patients Aged 3 Years and Older with NDO 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: Use Mirabegron for Extended-Release Oral Suspension The recommended starting and maximum doses of mirabegron for extended-release oral suspension, administered as extended-release oral suspension once daily, are shown in Table 1. The recommended dosages are determined based on patient weight. Evaluate patients periodically for potential dosage adjustment. For administration instructions, see Dosage and Administration.

Table 1: Mirabegron for Extended-Release Oral Suspension Recommended Dosage for Pediatric Patients Aged 3 Years and Older Weighing Less Than 35 kg as an Extended-Release Oral Suspension (Administered Orally Once Daily) 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 Pediatric Patients weighing 35 kg or more: Use MYRBETRIQ or Mirabegron for Extended-Release Oral Suspension The recommended starting dosage of mirabegron for extended-release oral suspension is 6 mL (48 mg) orally once daily. If needed, increase to a maximum dosage of mirabegron for extended-release oral suspension 10 mL (80 mg) orally once daily after 4 to 8 weeks. For administration instructions, see Dosage and Administration.

2.5 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. 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) Estimated GFR1 Body Weight Range Starting Dose Maximum Dose eGFR 30 to 89 mL/min/1.73 m 2 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 m 2 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 m 2 or undergoing dialysis Use is Not Recommended 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. 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) 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 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. 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) Estimated GFR 1 Starting Dose Maximum Dose eGFR 30 to 89 mL/min/1.73 m 2 6 mL (48 mg) 10 mL (80 mg) eGFR 15 to 29 mL/min/1.73 m 2 6 mL (48 mg) 6 mL (48 mg) eGFR < 15 mL/min/1.73 m 2 or undergoing dialysis Use is Not Recommended 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. 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) 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

2.6 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. After reconstitution with 100 mL water, the suspension contains 8 mg/mL of mirabegron.

2.7 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. Take with food to reduce potential exposure-related risks.

2.8 Missed Dose

Instruct patients to take any missed doses as soon as they remember, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped, and the next dose should be taken at the usual time.