Myrbetriq 50 mg/1
mirabegron · TABLET, FILM COATED, EXTENDED RELEASE · Astellas Pharma US, Inc.
Myrbetriq is a tablet, film coated, extended release containing mirabegron at 50 mg/1, taken oral. Manufactured by Astellas Pharma US, Inc..
Key Facts
- Brand Name
- Myrbetriq
- Generic Name
- mirabegron
- NDC Code (Product)
0469-2602- Manufacturer
- Astellas Pharma US, Inc.
- Strength
- 50 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA202611
- Drug Class
- beta3-Adrenergic Agonist [EPC]
- Marketing Start
- 06/28/2012
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) MYRBETRIQ Granules is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older. ( 1.2 ) 1.1 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 …
Dosage & Administration
2 DOSAGE AND A DM INISTRATION • 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 ) 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 ) • After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily. ( 2.2 ) 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 ) • Pediatric Patients weighing 35 kg or more: Use MYRBETRIQ or MYRBETRIQ Granules: o The recommended starting dosage of MYRBETRIQ is…
Contraindications
4 CONTRAINDICATIONS 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 ( 6.1 , 6.2 )] . Hypersensitivity to mirabegron or any inactive ingredients. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of coadministered drugs (e.g., ketoconazole, rifampin, solifenacin succinate, tamsulosin, and oral contraceptives) [see Clinical Pharmacology ( 12.3 )] . No dose adjustment is recommended when these drugs are coadministered with mirabegron. The following are drug interactions for which monitoring is recommended: • Drugs Metabolized by CYP2D6 : Mirabegron is a CYP2D6 inhibitor and, when used concomitantly with drugs metabolized by CYP2D6, especially narrow therapeutic index drugs, appropriate monitoring and possible dose adjustment of those drugs may be necessary. ( 5.4 , 7.1 , 12.3 ) • Digoxin : When initiating a combination of mirabegron and digoxin with or without solifenacin succinate, use the lowest dose of digoxin; monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. ( 7.2 , 12.3 ) 7.1 Drugs Metabolized by CYP2D6 Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure of drugs metabolized by CYP2D6 enzyme is inc…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. • Hypertension [see Warnings and Precautions ( 5.1 )] • Urinary Retention [see Warnings and Precautions ( 5.2 )] • Angioedema [see Warnings and Precautions ( 5.3 )] • Most commonly reported adverse reactions with MYRBETRIQ monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. ( 6.1 ) • Most commonly reported adverse reactions with MYRBETRIQ, in combination with solifenacin succinate in adult patients with OAB (> 2% and > placebo and > comparator), were dry mouth, urinary tract infection, constipation, and tachycardia. ( 6.1 ) • Most commonly reported adverse reactions with MYRBETRIQ/MYRBETRIQ Granules in pediatric patients with NDO (≥ 3%) were UTI, nasopharyngitis, constipation, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical tri…
Frequently Asked Questions
What is Myrbetriq used for?
Myrbetriq contains mirabegron. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Myrbetriq a controlled substance?
Myrbetriq is not classified as a controlled substance by the DEA.
What is the generic name for Myrbetriq?
The generic name for Myrbetriq is mirabegron. There are 11 other brand versions of mirabegron.
What is the NDC code for Myrbetriq 50 mg/1?
The NDC (National Drug Code) for Myrbetriq 50 mg/1 is 0469-2602, listed by Astellas Pharma US, Inc..