Myrbetriq
(mirabegron)Dosage & Administration
Adult or Pediatric Patients with Renal or Hepatic Impairment: Refer to the full prescribing information for recommended dosage.
Preparation for MYRBETRIQ Granules: Refer to the full prescribing information.
Administration
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Myrbetriq Prescribing Information
Adult Overactive Bladder (OAB)
MYRBETRIQ Monotherapy
MYRBETRIQ® 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 Succinate
MYRBETRIQ, 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.
1.2 Pediatric Neurogenic Detrusor Overactivity (NDO)
MYRBETRIQ Granules
MYRBETRIQ® Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older.
MYRBETRIQ
MYRBETRIQ is indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.
2 DOSAGE AND ADMINISTRATION
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 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.
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 .
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 .
2.3 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 ], 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 .
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 .
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 .
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 ]. For administration instructions, see Dosage and Administration .
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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 ]. For administration instructions, see Dosage and Administration .
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 ]. For administration instructions, see Dosage and Administration .
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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 ]. For administration instructions, see Dosage and Administration .
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 and Use in Specific Populations ]. For administration instructions, see Dosage and Administration .
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 ]. For administration instructions, see Dosage and Administration .
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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 and Use in Specific Populations ]. For administration instructions, see Dosage and Administration .
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 ]. For administration instructions, see Dosage and Administration .
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 ].
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 ].
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 ]. Take with food to reduce potential exposure-related risks [see Use in Specific Populations ].
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.
MYRBETRIQ (mirabegron extended-release tablets) are supplied in two different strengths as described below:
• 25 mg oval, brown, film-coated tablet, debossed with the 
(Astellas logo) and “325”
• 50 mg oval, yellow, film-coated tablet, debossed with the 
(Astellas logo) and “355”
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.
Pregnancy
Risk Summary
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 [see Data].
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.
Data
Animal Data
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. In utero and lactational exposure did not affect developmental milestones, behavior, or fertility of offspring. No effects were observed at 30 mg/kg/day.
Lactation
Risk Summary
There are no data on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production. Mirabegron-related material was present in rat milk and in the stomach of nursing pups following administrations of a single 10 mg/kg oral dose of 14C-labeled mirabegron to lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MYRBETRIQ/MYRBETRIQ Granules and any potential adverse effects on the breastfed child from mirabegron or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness have been established only for the following pediatric indications:
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- MYRBETRIQ: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older and weighing 35 kg or more.
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- MYRBETRIQ Granules: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older.
The safety and effectiveness of MYRBETRIQ/MYRBETRIQ Granules in pediatric patients aged 3 years and older have been established for the treatment of neurogenic detrusor overactivity (NDO) and the information on this use is discussed throughout the labeling. Use of MYRBETRIQ/MYRBETRIQ Granules for this indication is supported by evidence from a 52-week, open-label, baseline-controlled, multicenter, dose titration trial in pediatric patients 3 years of age and older with NDO (Study 9) [see Adverse Reactions , Clinical Studies ]. Results showed an improvement from baseline in maximum cystometric (bladder) capacity (MCC) with MYRBETRIQ/MYRBETRIQ Granules use [see Clinical Studies ]. The most commonly reported adverse reactions in Study 9 (≥ 3%) were UTI, nasopharyngitis, constipation, and headache. Increased mean systolic and diastolic blood pressures with use of MYRBETRIQ/MYRBETRIQ Granules occurred in patients less than 12 years of age with larger increases in patients younger than 8 years of age [see Adverse Reactions ].
Take MYRBETRIQ/MYRBETRIQ Granules with food to reduce potential exposure-related risks, such as increased heart rate, as predicted by modeling of vital signs data in Study 9 [see Clinical Pharmacology ].
Geriatric Use
Of 5648 patients who received MYRBETRIQ monotherapy in the phase 2 and 3 studies for OAB, 2029 (35.9%) were 65 years of age or older, and 557 (9.9%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients younger than 65 years of age and those 65 years of age or older in these studies.
Renal Impairment
MYRBETRIQ/MYRBETRIQ Granules have not been studied in patients with End-Stage Renal Disease (eGFR < 15 mL/min/1.73 m2) or patients requiring hemodialysis and, therefore, is not recommended for use in these patient populations. No dose adjustment is necessary in patients with mild or moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m2).
In adult patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), the daily dose of MYRBETRIQ should not exceed 25 mg. In pediatric patients with severe renal impairment, the daily dose of MYRBETRIQ/MYRBETRIQ Granules should not exceed the recommended starting dose [see Clinical Pharmacology ].
Hepatic Impairment
MYRBETRIQ/MYRBETRIQ Granules 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 adult patients with moderate hepatic impairment (Child-Pugh Class B), the daily dose of MYRBETRIQ should not exceed 25 mg. In pediatric patients with moderate hepatic impairment (Child-Pugh Class B), the daily dose of MYRBETRIQ/MYRBETRIQ Granules should not exceed the recommended starting dose [see Clinical Pharmacology ].
MYRBETRIQ/MYRBETRIQ Granules is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet or oral suspension [see Adverse Reactions ].
Increases in Blood Pressure
Increases in Blood Pressure in Adults
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) [see Clinical Pharmacology ].
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.
Increases in Blood Pressure in Pediatric Patients 3 Years and Older
MYRBETRIQ/MYRBETRIQ Granules can increase blood pressure in pediatric patients. Blood pressure increases may be larger in children (3 to less than 12 years of age) than in adolescents (12 to less than 18 years of age). Periodic blood pressure determinations are recommended. MYRBETRIQ/MYRBETRIQ Granules is not recommended for use in pediatric patients with severe uncontrolled hypertension, defined as a systolic and/or diastolic blood pressure above the 99th percentile plus 5 mm Hg for age, sex, and stature using appropriate reference values [see Adverse Reactions ].
Urinary Retention in Patients with Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Medications for OAB
In patients taking MYRBETRIQ, urinary retention has been reported to occur in patients with bladder outlet obstruction (BOO) and in patients taking muscarinic antagonist medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with mirabegron; however, MYRBETRIQ should still be administered with caution to patients with clinically significant BOO. For example, monitor these patients for signs and symptoms of urinary retention. MYRBETRIQ should also be administered with caution to patients taking muscarinic antagonist medications for the treatment of OAB, including solifenacin succinate [see Clinical Pharmacology ].
Angioedema
Angioedema of the face, lips, tongue, and/or larynx has been reported with MYRBETRIQ/MYRBETRIQ Granules. In some cases, angioedema occurred after the first dose, however, cases have been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue MYRBETRIQ/MYRBETRIQ Granules and provide appropriate therapy and/or measures necessary to ensure a patent airway [see Adverse Reactions ].
Patients Taking Drugs Metabolized by CYP2D6
Since MYRBETRIQ/MYRBETRIQ Granules is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates is increased when coadministered with MYRBETRIQ/MYRBETRIQ Granules. Therefore, appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6 [see Drug Interactions and Clinical Pharmacology ].