Myrbetriq
(Mirabegron)Dosage & Administration
Estimated GFR Estimated GFR using the modification of diet in renal disease (MDRD) formula | 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 m2or requiring dialysis | Not recommended | |
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 | |
Estimated GFR Estimate GFR using a validated eGFR estimating equation for the pediatric age range of the approved indication. | 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 m2or undergoing dialysis | Use is Not Recommended | ||
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 | ||
Estimated GFR Estimate GFR using a validated eGFR estimating equation for the pediatric age range of the approved indication. | 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 m2or undergoing dialysis | 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 | |
• 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
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Myrbetriq Prescribing Information
Indications and Usage (
Dosage and Administration (
• 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. Do not combine MYRBETRIQ and MYRBETRIQ Granules to achieve the total dose. A recommended dosage for MYRBETRIQ Granules for adults has not been determined.OAB in Adults• The recommended starting dose of MYRBETRIQ is 25 mg orally once daily, either alone or in combination with solifenacin succinate 5 mg orally once daily.• After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily.NDO in Pediatric Patients 3 Years and Older• Pediatric Patients weighing less than 35 kg: Use MYRBETRIQ Granules: The recommended starting dose of MYRBETRIQ Granules 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 MYRBETRIQ Granules:o The recommended starting dosage of MYRBETRIQ is 25 mg orally once daily. After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily.o The recommended starting dosage of MYRBETRIQ Granules, 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 MYRBETRIQ Granules 10 mL (80 mg) orally once daily
• MYRBETRIQ:o Adult patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush. Take with or without food.o Pediatric patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush. Take with food.
• MYRBETRIQ Granules:o Pediatric patients: Take MYRBETRIQ Granules prepared as an extended-release oral suspension. Take with food.
• Do not combine MYRBETRIQ and MYRBETRIQ Granules to achieve the total dose.
• A recommended dosage for MYRBETRIQ Granules for adults has not been determined.
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 | |
Estimated GFR Estimated GFR using the modification of diet in renal disease (MDRD) formula | 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 m2or requiring dialysis | Not recommended | |
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 | |
Estimated GFR Estimate GFR using a validated eGFR estimating equation for the pediatric age range of the approved indication. | 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 m2or undergoing dialysis | Use is Not Recommended | ||
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 | ||
Estimated GFR Estimate GFR using a validated eGFR estimating equation for the pediatric age range of the approved indication. | 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 m2or undergoing dialysis | 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 | |
• 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
Warnings and Precautions, Increase in Blood Pressure (
MYRBETRIQ/MYRBETRIQ Granules can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. MYRBETRIQ/MYRBETRIQ Granules is not recommended for use in patients with severe uncontrolled hypertension (defined as systolic blood pressure greater than or equal to 180 mm Hg and/or diastolic blood pressure greater than or equal to 110 mm Hg)
In two, randomized, placebo-controlled, healthy adult volunteer studies, MYRBETRIQ was associated with dose-related increases in supine blood pressure. In these studies, at the maximum recommended dose of 50 mg, the mean maximum increase in systolic/diastolic blood pressure was approximately 3.5/1.5 mm Hg greater than placebo.
In contrast, in adult OAB patients in clinical trials, MYRBETRIQ, taken as monotherapy or in combination with solifenacin succinate 5 mg, the mean increase in systolic and diastolic blood pressure at the maximum recommended mirabegron dose of 50 mg was approximately 0.5 to 1 mm Hg greater than placebo. Worsening of pre-existing hypertension was reported infrequently in patients taking MYRBETRIQ.
MYRBETRIQ is a beta-3 adrenergic agonist indicated for the treatment of:
• Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency, either alone or in combination with the muscarinic antagonist solifenacin succinate. ()1.1 Adult Overactive Bladder (OAB)MYRBETRIQ MonotherapyMYRBETRIQ®is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.
MYRBETRIQ Combination Therapy with Solifenacin SuccinateMYRBETRIQ, in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.
• Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ()1.2 Pediatric Neurogenic Detrusor Overactivity (NDO)MYRBETRIQ GranulesMYRBETRIQ®Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older.MYRBETRIQMYRBETRIQ is indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.
MYRBETRIQ Granules is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older. (
• 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. Do not combine MYRBETRIQ and MYRBETRIQ Granules to achieve the total dose. A recommended dosage for MYRBETRIQ Granules for adults has not been determined. ()2.1 Important Dosage InformationMYRBETRIQ 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 and Dosage and Administration ].
• Do not combine MYRBETRIQ and MYRBETRIQ Granules to achieve the total dose.
• A recommended dosage for MYRBETRIQ Granules for adults has not been determined.OAB in Adults• The recommended starting dose of MYRBETRIQ is 25 mg orally once daily, either alone or in combination with solifenacin succinate 5 mg orally once daily. ()2.2 Recommended Dosage for Adult Patients with OABMYRBETRIQ MonotherapyThe 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.MYRBETRIQ Combination Therapy with Solifenacin SuccinateThe 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.• After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily. ()2.2 Recommended Dosage for Adult Patients with OABMYRBETRIQ MonotherapyThe 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.MYRBETRIQ Combination Therapy with Solifenacin SuccinateThe 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.NDO in Pediatric Patients 3 Years and Older• Pediatric Patients weighing less than 35 kg: Use MYRBETRIQ Granules: The recommended starting dose of MYRBETRIQ Granules 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. ()2.3 Recommended Dosage for Pediatric Patients Aged 3 Years and Older with NDOFor 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 GranulesThe recommendedstarting and maximum doses of MYRBETRIQ Granules, administered as extended-release oralsuspensiononce daily[see Dosage and Administration ], are shown in Table 1. The recommended dosages aredetermined based on patient weight. Evaluate patients periodically for potential dosage adjustment. For administrationinstructions,see Dosage and Administration.Table 1: MYRBETRIQ Granules 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 RangeStarting DoseMaximum Volume11 kg to less than 22 kg3 mL (24 mg)6 mL (48 mg)22 kg to less than 35 kg4 mL (32 mg)8 mL (64 mg)Greater than or equal to 35 kgRefer to information in next sectionPediatric Patients weighing 35 kg or more: Use MYRBETRIQ or MYRBETRIQ GranulesThe 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 .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 .• Pediatric Patients weighing 35 kg or more: Use MYRBETRIQ or MYRBETRIQ Granules:o The recommended starting dosage of MYRBETRIQ is 25 mg orally once daily. After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily. ()2.3 Recommended Dosage for Pediatric Patients Aged 3 Years and Older with NDOFor 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 GranulesThe recommendedstarting and maximum doses of MYRBETRIQ Granules, administered as extended-release oralsuspensiononce daily[see Dosage and Administration ], are shown in Table 1. The recommended dosages aredetermined based on patient weight. Evaluate patients periodically for potential dosage adjustment. For administrationinstructions,see Dosage and Administration.Table 1: MYRBETRIQ Granules 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 RangeStarting DoseMaximum Volume11 kg to less than 22 kg3 mL (24 mg)6 mL (48 mg)22 kg to less than 35 kg4 mL (32 mg)8 mL (64 mg)Greater than or equal to 35 kgRefer to information in next sectionPediatric Patients weighing 35 kg or more: Use MYRBETRIQ or MYRBETRIQ GranulesThe 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 .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 .o The recommended starting dosage of MYRBETRIQ Granules, 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 MYRBETRIQ Granules 10 mL (80 mg) orally once daily ()2.3 Recommended Dosage for Pediatric Patients Aged 3 Years and Older with NDOFor 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 GranulesThe recommendedstarting and maximum doses of MYRBETRIQ Granules, administered as extended-release oralsuspensiononce daily[see Dosage and Administration ], are shown in Table 1. The recommended dosages aredetermined based on patient weight. Evaluate patients periodically for potential dosage adjustment. For administrationinstructions,see Dosage and Administration.Table 1: MYRBETRIQ Granules 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 RangeStarting DoseMaximum Volume11 kg to less than 22 kg3 mL (24 mg)6 mL (48 mg)22 kg to less than 35 kg4 mL (32 mg)8 mL (64 mg)Greater than or equal to 35 kgRefer to information in next sectionPediatric Patients weighing 35 kg or more: Use MYRBETRIQ or MYRBETRIQ GranulesThe 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 .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 .
Estimated GFR Estimated GFR using the modification of diet in renal disease (MDRD) formula | 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 m2or requiring dialysis | Not recommended | |
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 | |
Estimated GFR Estimate GFR using a validated eGFR estimating equation for the pediatric age range of the approved indication. | 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 m2or undergoing dialysis | Use is Not Recommended | ||
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 | ||
Estimated GFR Estimate GFR using a validated eGFR estimating equation for the pediatric age range of the approved indication. | 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 m2or undergoing dialysis | 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 | |
• 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
• MYRBETRIQ:o Adult patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush. Take with or without food. ()2.7 Administration InstructionsAdministration instructions for MYRBETRIQ and MYRBETRIQ Granules differ based on the patient population.MYRBETRIQAdult 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 ].MYRBETRIQ GranulesAdult 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 ]. Take with food to reduce potential exposure-related risks[see Use in Specific Populations ].o Pediatric patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush. Take with food. ()2.7 Administration InstructionsAdministration instructions for MYRBETRIQ and MYRBETRIQ Granules differ based on the patient population.MYRBETRIQAdult 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 ].MYRBETRIQ GranulesAdult 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 ]. Take with food to reduce potential exposure-related risks[see Use in Specific Populations ].
• MYRBETRIQ Granules:o Pediatric patients: Take MYRBETRIQ Granules prepared as an extended-release oral suspension. Take with food. ()2.7 Administration InstructionsAdministration instructions for MYRBETRIQ and MYRBETRIQ Granules differ based on the patient population.MYRBETRIQAdult 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 ].MYRBETRIQ GranulesAdult 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 ]. Take with food to reduce potential exposure-related risks[see Use in Specific Populations ].
MYRBETRIQ (mirabegron extended-release tablets) are supplied in two different strengths as described below:
• 25 mg oval, brown, film-coated tablet, debossed with the 
• 50 mg oval, yellow, film-coated tablet, debossed with the 
MYRBETRIQ Granules (mirabegron for extended-release oral suspension): Each bottle is filled with approximately 8.3 g of yellowish white granules, which contain 830 mg of mirabegron. After reconstitution with 100 mL water, the oral suspension is pale brownish yellow to yellow with 8 mg/mL of mirabegron.
There are no studies with the use of MYRBETRIQ/MYRBETRIQ Granules in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. Mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the MRHD. At maternally-toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed
No embryo-fetal lethality or morphological fetal developmental abnormalities were produced in pregnant rats following daily oral administration of mirabegron during the period of organogenesis (Days 7 to 17 of gestation) at 0, 10, 30, 100, or 300 mg/kg, doses which were associated with systemic exposures (AUC) 0, 1, 6, 22, and 96-fold the MRHD. Skeletal variations (wavy ribs, delayed ossification) were observed in fetuses at doses 22-fold the systemic exposure at the MRHD and were reversible during development. Exposures 96-fold the MRHD were maternally-toxic (mortality, decreased body weight gain) and associated with fetal growth reduction.
Pregnant rabbits were treated with daily oral doses of mirabegron at 0, 3, 10, or 30 mg/kg/day during the period of organogenesis (Days 6 to 20 of gestation), which resulted in plasma exposures that were 0, 1, 14, or 36-fold the MRHD based on AUC. At 10 mg/kg/day (14-fold the MRHD) and higher, fetal body weights were reduced. At 30 mg/kg/day, maternal toxicity (increased heart rate, mortality, reduced body weight gain, reduced food consumption) occurred, and fetal deaths, fetal cardiomegaly and fetal dilated aortae were observed at systemic exposure levels (AUC) 36-fold the MRHD.
In a pre- and postnatal developmental study, rats were treated with daily oral doses of mirabegron at 0, 10, 30, or 100 mg/kg/day (0, 1, 6, or 22-fold the MRHD) from day 7 of gestation until day 20 after birth. Decreased maternal body weight was observed along with decreased pup survival in the first few days after birth (92.7% survival) compared to the control group (98.8% survival), at 100 mg/kg/day (22-fold the MRHD). Pup body weight gain was reduced until postnatal day 7 but not further affected throughout the remainder of the lactation period.
The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
MYRBETRIQ/MYRBETRIQ Granules is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet or oral suspension
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In three, 12-week, double-blind, placebo-controlled, safety and efficacy studies in patients with OAB (Studies 1, 2, and 3), MYRBETRIQ was evaluated for safety in 2736 patients
MYRBETRIQ was also evaluated for safety in 1632 patients who received MYRBETRIQ 50 mg once daily (n=812 patients) or MYRBETRIQ 100 mg (n=820 patients) in a 1-year, randomized, fixed-dose, double-blind, active-controlled, safety study in patients with OAB (Study 4). Of these patients, 731 received MYRBETRIQ in a previous 12-week study. In Study 4, 1385 patients received MYRBETRIQ continuously for at least 6 months, 1311 patients received MYRBETRIQ for at least 9 months, and 564 patients received MYRBETRIQ for at least 1 year.
The most frequent adverse events (0.2%) leading to discontinuation in Studies 1, 2, and 3 for the 25 mg or 50 mg dose were nausea, headache, hypertension, diarrhea, constipation, dizziness, and tachycardia.
Atrial fibrillation (0.2%) and prostate cancer (0.1%) were reported as serious adverse events by more than 1 patient and at a rate greater than placebo.
Table 8lists the adverse reactions, derived from all adverse events, that were reported in Studies 1, 2, and 3 at an incidence greater than placebo and in 1% or more of patients treated with MYRBETRIQ 25 mg or 50 mg once daily for up to 12 weeks. The most commonly reported adverse reactions (greater than 2% of MYRBETRIQ patients and greater than placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache.
Adverse Reaction | Placebo (%) | MYRBETRIQ 25 mg (%) | MYRBETRIQ 50 mg (%) |
Number of Patients | 1380 | 432 | 1375 |
HypertensionIncludes reports of blood pressure above the normal range, and BP increased from baseline, occurring predominantly in subjects with baseline hypertension. | 7.6 | 11.3 | 7.5 |
Nasopharyngitis | 2.5 | 3.5 | 3.9 |
Urinary Tract Infection | 1.8 | 4.2 | 2.9 |
Headache | 3.0 | 2.1 | 3.2 |
Constipation | 1.4 | 1.6 | 1.6 |
Upper Respiratory Tract Infection | 1.7 | 2.1 | 1.5 |
Arthralgia | 1.1 | 1.6 | 1.3 |
Diarrhea | 1.3 | 1.2 | 1.5 |
Tachycardia | 0.6 | 1.6 | 1.2 |
Abdominal Pain | 0.7 | 1.4 | 0.6 |
Fatigue | 1.0 | 1.4 | 1.2 |
Other adverse reactions reported by less than 1% of patients treated with MYRBETRIQ in Studies 1, 2, or 3 included:
Table 9lists the rates of the most commonly reported adverse reactions, derived from all adverse events in patients treated with MYRBETRIQ 50 mg for up to 52 weeks in Study 4. The most commonly reported adverse reactions (> 3% of MYRBETRIQ patients) were hypertension, urinary tract infection, headache, and nasopharyngitis.
Adverse Reaction | MYRBETRIQ 50 mg (%) | Active Control (%) |
Number of Patients | 812 | 812 |
Hypertension | 9.2 | 9.6 |
Urinary Tract Infection | 5.9 | 6.4 |
Headache | 4.1 | 2.5 |
Nasopharyngitis | 3.9 | 3.1 |
Back Pain | 2.8 | 1.6 |
Constipation | 2.8 | 2.7 |
Dry Mouth | 2.8 | 8.6 |
Dizziness | 2.7 | 2.6 |
Sinusitis | 2.7 | 1.5 |
Influenza | 2.6 | 3.4 |
Arthralgia | 2.1 | 2.0 |
Cystitis | 2.1 | 2.3 |
In Study 4, in patients treated with MYRBETRIQ 50 mg once daily, adverse reactions leading to discontinuation reported by more than 2 patients and at a rate greater than active control included: constipation (0.9%), headache (0.6%), dizziness (0.5%), hypertension (0.5%), dry eyes (0.4%), nausea (0.4%), vision blurred (0.4%), and urinary tract infection (0.4%). Serious adverse events reported by at least 2 patients and exceeding active control included cerebrovascular accident (0.4%) and osteoarthritis (0.2%). Serum ALT/AST increased from baseline by greater than 10-fold in 2 patients (0.3%) taking MYRBETRIQ 50 mg; and these markers subsequently returned to baseline while both patients continued MYRBETRIQ.
In Study 4, serious adverse events of neoplasm were reported by 0.1%, 1.3%, and 0.5% of patients treated with MYRBETRIQ 50 mg, MYRBETRIQ 100 mg, and active control once daily, respectively. Neoplasms reported by 2 patients treated with MYRBETRIQ 100 mg included breast cancer, lung neoplasm malignant, and prostate cancer. A causal relationship between mirabegron and these reported neoplasms has not been established.
In a separate clinical study in Japan, a single case was reported as Stevens-Johnson syndrome with increased serum ALT, AST, and bilirubin in a patient taking MYRBETRIQ 100 mg as well as an herbal medication (Kyufu Gold).
In three, 12-week, double-blind, randomized, active-controlled safety and efficacy studies in patients with OAB (Studies 5, 6, and 7), combination treatment of MYRBETRIQ and solifenacin succinate was evaluated for safety in 6818 patients
MYRBETRIQ 50 mg and solifenacin succinate 5 mg coadministration was also evaluated for safety in 1814 patients in a 52-week, double-blind, randomized, active-controlled study in patients with OAB (Study 8)
In Studies 5, 6, and 7, the most commonly reported adverse reactions (greater than 2% of patients treated with combination therapy of MYRBETRIQ and solifenacin succinate 5 mg, and greater than placebo and/or MYRBETRIQ or solifenacin succinate comparator at the same dose as in the combination treatment) were dry mouth, urinary tract infection, constipation, and tachycardia. The most frequent adverse reactions (≥ 0.2%) leading to discontinuation in the coadministration trials were dry mouth and urinary retention.
Table 10lists the adverse reactions, derived from all adverse events that were reported in Studies 5, 6, and 7 in 1% or more of patients treated with MYRBETRIQ 25 mg or 50 mg coadministered with solifenacin succinate 5 mg and at an incidence greater than placebo and mirabegron or solifenacin succinate comparator at the same dose as in the combination treatment when administered once daily for up to 12 weeks.
Adverse Reaction | Placebo (%) | MYRBETRIQ 25 mg (%) | MYRBETRIQ 50 mg (%) | Solifenacin Succinate 5 mg (%) | MYRBETRIQ 25 mg + Solifenacin Succinate 5 mg (%) | MYRBETRIQ 50 mg + Solifenacin Succinate 5 mg (%) |
Number of Patients | 510 | 500 | 500 | 1288 | 997 | 1706 |
Dry Mouth | 2.2 | 3.8 | 3.6 | 6.5 | 9.3 | 7.2 |
Urinary Tract InfectionsIncludes any recorded treatment-emergent UTI. | 5.3 | 4.0 | 4.2 | 3.6 | 7.0 | 4.0 |
Constipation | 1.2 | 1.2 | 2.8 | 2.4 | 4.2 | 3.9 |
Tachycardia | 0.8 | 1.6 | 1.6 | 0.7 | 2.2 | 0.9 |
Dyspepsia | 0.6 | 0.4 | 0.2 | 0.7 | 1.1 | 1.3 |
Dizziness | 0.4 | 0.8 | 1.2 | 1.2 | 1.3 | 0.4 |
Vision Blurred | 0.4 | 0.2 | 0.2 | 0.9 | 0.7 | 1.1 |
Arthralgia | 0.8 | 0.8 | 0.8 | 0.8 | 0.5 | 1.1 |
In Study 8, the most common adverse reactions (more than 2% of patients treated with coadministration of MYRBETRIQ and solifenacin succinate and exceeding comparator rate) were UTI, dry mouth, constipation, and headache. The most frequent adverse reactions leading to discontinuation in the trial were constipation (0.2%), urinary retention (0.2%), urinary hesitation (0.2%), and vision blurred (0.2%).
In Study 8, serious adverse events of neoplasm were reported by 0.7%, 0.3%, and 0% of patients who received coadministration of MYRBETRIQ 50 mg and solifenacin succinate 5 mg, MYRBETRIQ 50 mg monotherapy, and solifenacin succinate 5 mg monotherapy, respectively. Neoplasms reported by more than 1 patient who received coadministration with MYRBETRIQ 50 mg and solifenacin succinate 5 mg included basal cell carcinoma (n=3), breast cancer (n=2), melanoma (n=2), and squamous cell carcinoma (n=2). A causal relationship between the coadministration of mirabegron and solifenacin succinate and these reported neoplasms has not been established.
Table 11lists the adverse reactions, derived from all adverse events that were reported at an incidence greater than comparator and in 2% or more of patients treated with MYRBETRIQ 50 mg coadministered with solifenacin succinate 5 mg once daily for up to 52 weeks in Study 8.
Adverse Reaction | MYRBETRIQ 50 mg (%) | Solifenacin Succinate 5 mg (%) | MYRBETRIQ 50 mg + Solifenacin Succinate 5 mg (%) |
Number of Patients | 305 | 303 | 1206 |
Urinary Tract InfectionsIncludes any recorded treatment-emergent UTI. | 6.2 | 5.9 | 8.4 |
Dry Mouth | 3.9 | 5.9 | 6.1 |
Constipation | 1.0 | 2.3 | 3.3 |
Headache | 1.6 | 1.7 | 2.9 |
The safety of MYRBETRIQ/MYRBETRIQ Granules was evaluated in a 52-week, open-label, baseline-controlled, multicenter, dose titration study (Study 9)
The most commonly reported adverse reactions were UTI, nasopharyngitis, constipation, and headache.
Table 12lists the adverse reactions that were reported in 2% or more of patients treated with MYRBETRIQ/MYRBETRIQ Granules for oral suspension in Study 9.
Adverse Reaction | Percentage (%) of Patients Reporting Adverse Reactions N=86 |
Number of Patients | 51 (59.3) |
Urinary Tract InfectionIncludes any recorded UTI while patient was on treatment with MYRBETRIQ/MYRBETRIQ Granules. | 24.4 |
Nasopharyngitis | 5.8 |
Constipation | 4.7 |
Headache | 3.5 |
Nausea | 2.3 |
Gastroenteritis | 2.3 |
Rhinitis | 2.3 |
Cough | 2.3 |
Mean systolic and diastolic blood pressures increased in Study 9 by 4.3 mm Hg and 1.7 mm Hg, respectively, in patients less than 12 years of age on MYRBETRIQ/MYRBETRIQ Granules at a dose equivalent of MYRBETRIQ 50 mg daily dose in adults. The blood pressure increases were larger in patients less than 8 years of age with mean systolic and diastolic blood pressure increases of 5.9 mm Hg and 2.3 mm Hg, respectively. Ten (24%) patients less than 12 years of age who were normotensive at baseline had at least one blood pressure measured at or above the 95thpercentile for age, sex, and stature during Study 9. Stage 1 hypertension, defined as repeated blood pressure measurements at or above the 95thpercentile for age, sex, and stature, was sustained in six of these 10 patients (60%) at the end of the study.
The following adverse reactions have been identified during post-approval use of MYRBETRIQ/MYRBETRIQ Granules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following events have been reported in association with mirabegron use in worldwide postmarketing experience:
There have been postmarketing reports of confusion, hallucinations, insomnia, and anxiety in patients taking mirabegron. The majority of these patients had pre-existing medical conditions or concomitant medications that may cause confusion, hallucinations, insomnia, and anxiety. A causal relationship between mirabegron and these disorders has not been established.