Drug Detail:Myrbetriq (Mirabegron [ mir-a-beg-ron ])
Generic Name: MIRABEGRON 25mg
Dosage Form: tablet, film coated, extended release
Drug Class: Urinary antispasmodics
2.1 Important Dosage Information
MYRBETRIQ and MYRBETRIQ Granules are two different products and they are not substitutable on a milligram-per-milligram basis:
• Select the recommended product (MYRBETRIQ or MYRBETRIQ Granules) based on the indication and patient’s weight [see Indications and Usage (1) and Dosage and Administration (2.2, 2.3, 2.4, 2.5)].
• Do not combine MYRBETRIQ and MYRBETRIQ Granules to achieve the total dose.
• A recommended dosage for MYRBETRIQ Granules for adults has not been determined.
2.2 Recommended Dosage for Adult Patients with OAB
MYRBETRIQ Monotherapy
The recommended starting dosage of MYRBETRIQ is 25 mg orally once daily. If needed, increase to the maximum dosage of MYRBETRIQ 50 mg orally once daily after 4 to 8 weeks. For administration instructions, see Dosage and Administration (2.7).
MYRBETRIQ Combination Therapy with Solifenacin Succinate
The recommended starting dosage for combination treatment is MYRBETRIQ 25 mg orally once daily and solifenacin succinate 5 mg orally once daily. If needed, increase to the maximum dosage of MYRBETRIQ 50 mg orally once daily after 4 to 8 weeks. Refer to the Prescribing Information for solifenacin succinate for additional information. For administration instructions, see Dosage and Administration (2.7).
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 MYRBETRIQ Granules) based on the patient’s weight.
Pediatric Patients weighing less than 35 kg: Use MYRBETRIQ Granules
The recommended starting and maximum doses of MYRBETRIQ Granules, administered as extended-release oral suspension once daily [see Dosage and Administration (2.6)], 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 (2.7).
|
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 MYRBETRIQ Granules
The recommended starting dosage of MYRBETRIQ is 25 mg orally once daily. If needed, increase to a maximum dosage of MYRBETRIQ 50 mg orally once daily after 4 to 8 weeks. For administration instructions, see Dosage and Administration (2.7).
The recommended starting dosage of MYRBETRIQ Granules is 6 mL (48 mg) orally once daily. If needed, increase to a maximum dosage of MYRBETRIQ Granules 10 mL (80 mg) orally once daily after 4 to 8 weeks. For administration instructions, see Dosage and Administration (2.7).
Recommended Dosage in Adult Patients with Renal or Hepatic Impairment
Dosage in Adults with Renal Impairment
The recommended dosage of MYRBETRIQ (administered orally once daily) in adult patients with renal impairment is described in Table 2 [see Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.7).
|
||
|
Estimated GFR* |
Starting Dose |
Maximum Dose |
|
eGFR 30 to 89 mL/min/1.73 m2 |
25 mg |
50 mg |
|
eGFR 15 to 29 mL/min/1.73 m2 |
25 mg |
25 mg |
|
eGFR < 15 mL/min/1.73 m2 or requiring dialysis |
Not recommended |
|
Dosage in Adults with Hepatic Impairment
The recommended dosage of MYRBETRIQ (administered orally once daily) in adult patients with hepatic impairment is described in Table 3 [see Use in Specific Populations (8.7)]. For administration instructions, see Dosage and Administration (2.7).
|
Hepatic Impairment Classification |
Starting Dose |
Maximum Dose |
|
Child-Pugh Class A (Mild hepatic impairment) |
25 mg |
50 mg |
|
Child-Pugh Class B (Moderate hepatic impairment) |
25 mg |
25 mg |
|
Child-Pugh Class C (Severe hepatic impairment) |
Not Recommended |
|
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 MYRBETRIQ Granules) based on the patient’s weight.
Pediatric Patients Weighing Less Than 35 kg with Renal or Hepatic Impairment: Use MYRBETRIQ Granules
Dosage in Pediatric Patients with Renal Impairment
The recommended dosage of MYRBETRIQ Granules in pediatric patients with renal impairment (administered orally once daily) is described in Table 4 [see Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.7).
|
|||
|
Estimated GFR* |
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 |
||
Dosage in Pediatric Patients with Hepatic Impairment
The recommended dosage of MYRBETRIQ Granules in pediatric patients with hepatic impairment (administered orally once daily) is described in Table 5 [see Use in Specific Populations (8.7)]. For administration instructions, see Dosage and Administration (2.7).
|
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 MYRBETRIQ Granules
Dosage in Pediatric Patients with Renal Impairment
The recommended dosage of MYRBETRIQ in pediatric patients with renal impairment weighing 35 kg or more (administered orally once daily) is described in Table 2 (above). Note that the dosage is the same as for adult patients with renal impairment [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.7).
The recommended dosage of MYRBETRIQ Granules 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 (8.6)]. For administration instructions, see Dosage and Administration (2.7).
|
||
|
Estimated GFR* |
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 |
|
Dosage in Pediatric Patients with Hepatic Impairment
The recommended dosage of MYRBETRIQ in pediatric patients with hepatic impairment weighing 35 kg or more (administered orally once daily) is described in Table 3 (above). Note that the dosage is the same as for adult patients with hepatic impairment [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.7).
The recommended dosage of MYRBETRIQ Granules 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 (8.7)]. For administration instructions, see Dosage and Administration (2.7).
|
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 MYRBETRIQ Granules
The required dose for MYRBETRIQ Granules (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 (16.2)].
After reconstitution with 100 mL water, the suspension contains 8 mg/mL of mirabegron.
2.7 Administration Instructions
Administration instructions for MYRBETRIQ and MYRBETRIQ Granules differ based on the patient population.
MYRBETRIQ
Adult patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush. Take with or without food.
Pediatric patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush. Take with food [see Use in Specific Populations (8.4)].
MYRBETRIQ Granules
Adult patients: A recommended dosage for MYRBETRIQ Granules for adults has not been determined.
Pediatric patients: Take MYRBETRIQ Granules prepared as an extended-release oral suspension [see Dosage and Administration (2.6)]. Take with food to reduce potential exposure-related risks [see Use in Specific Populations (8.4)].
