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MIRABEGRON is a brand name for Mirabegron. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Mirabegron extended-release tablets are 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. ( 1.1 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Extended-Release Tablets…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Mirabegron extended-release tablets 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 (mirabegron extended-release tablets or mirabegron for extended-release oral suspension) based on the indication.
OAB in Adults The recommended starting dose of mirabegron extended-release tablets is 25 mg orally once daily. 2 ) After 4 to 8 weeks, the mirabegron extended-release tablets dose may be increased to 50 mg orally once daily. 2 ) Adult Patients with Renal or Hepatic Impairment: Refer to the full prescribing information for recommended dosage.
4 ) Administration Mirabegron Extended-Release Tablets: Adult patients: Swallow mirabegron extended-release tablets whole with water. Do not chew, divide, or crush. Take with or without food. 1 Important Dosage Information Mirabegron extended-release tablets 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 (mirabegron extended-release tablets or mirabegron for extended-release oral suspension) based on the indication [see Indications and Usage ( 1 )] .
2 Recommended Dosage for Adult Patients with OAB Mirabegron Extended-Release Tablets Monotherapy The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to the maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks.
7 ) . 's MYRBETRIQ (mirabegron extended-release tablets). 6 )]. 7 ).
Table 2:
Mirabegron Extended-Release Tablets Recommended Dosage in Adult Patients with Renal Impairment (Administered Orally Once Daily) Estimated GFR Estimated GFR using the modification of diet in renal disease (MDRD) formula. 7 )]. 7 ). 's MYRBETRIQ (mirabegron extended-release tablets).
's marketing exclusivity rights, this drug product is not labeled with that information. 7 Administration Instructions Mirabegron Extended-Release Tablets Adult patients: Swallow mirabegron extended-release tablets whole with water.
Do not chew, divide, or crush. Take with or without food. 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.
6 ADVERSE REACTIONS Most commonly reported adverse reactions with mirabegron monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
gov/medwatch. The following adverse reactions are discussed in more detail in other sections of the labeling. 1 Clinical Trials Experience 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.
1 )] . Study 1 also included an active control. For the combined Studies 1, 2, and 3, 432 patients received mirabegron extended-release tablets 25 mg, 1375 received mirabegron extended-release tablets 50 mg, and 929 received mirabegron extended-release tablets 100 mg once daily.
In these studies, the majority of the patients were Caucasian (94%) and female (72%) with a mean age of 59 years (range 18 to 95 years). Mirabegron extended-release tablets were also evaluated for safety in 1632 patients who received mirabegron extended-release tablets 50 mg once daily (n=812 patients) or mirabegron extended-release tablets 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 mirabegron extended-release tablets in a previous 12-week study. In Study 4, 1385 patients received mirabegron extended-release tablets continuously for at least 6 months, 1311 patients received mirabegron extended-release tablets for at least 9 months, and 564 patients received mirabegron extended-release tablets for at least 1 year.
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. 1%) were reported as serious adverse events by more than 1 patient and at a rate greater than placebo.
5 WARNINGS AND PRECAUTIONS Increases in Blood Pressure : Can increase blood pressure in adult patients. Periodically monitor blood pressure, especially in hypertensive patients. Mirabegron extended-release tablets are not recommended in patients with severe uncontrolled hypertension.
1 ) Urinary Retention in Patients With Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Drugs for Overactive Bladder : Administer with caution in these patients because of risk of urinary retention. 2 ) Angioedema : Angioedema of the face, lips, tongue, and/or larynx has been reported with mirabegron.
1 Increases in Blood Pressure Increases in Blood Pressure in Adults Mirabegron extended-release tablets can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. 2 )]. In two, randomized, placebo-controlled, healthy adult volunteer studies, mirabegron extended-release tablets were associated with dose-related increases in supine blood pressure.
5 mm Hg greater than placebo. 5 to 1 mm Hg greater than placebo. Worsening of pre-existing hypertension was reported infrequently in patients taking mirabegron extended-release tablets. Increases in Blood Pressure in Pediatric Patients 3 Years and Older Mirabegron extended-release tablets 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. Mirabegron extended-release tablets is not recommended for use in pediatric patients with severe uncontrolled hypertension, defined as a systolic and/or diastolic blood pressure above the 99 th percentile plus 5 mm Hg for age, sex, and stature using appropriate reference values.
's MYRBETRIQ (mirabegron extended-release tablets). 's marketing exclusivity rights, this drug product is not labeled with that information. 2 Urinary Retention in Patients with Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Medications for OAB In patients taking mirabegron extended-release tablets, 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.
4 CONTRAINDICATIONS Hypersensitivity to mirabegron or any inactive ingredients. 2 )] .
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Table 8 lists 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 mirabegron extended-release tablets 25 mg or 50 mg once daily for up to 12 weeks.
The most commonly reported adverse reactions (greater than 2% of mirabegron extended-release tablets patients and greater than placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache.
Table 8:
Percentages of Patients with Adverse Reactions, Derived from All Adverse Events, Exceeding Placebo Rate and Reported in ≥ 1% of OAB Patients Treated with Mirabegron Extended-Release Tablets, 25 mg or 50 mg Once Daily in Studies 1, 2, and 3 Adverse Reaction Placebo (%) Mirabegron Extended- Release Tablets 25 mg (%) Mirabegron Extended- Release Tablets 50 mg (%) Number of Patients 1380 432 1375 Hypertension Includes reports of blood pressure above the normal range, and BP increased from baseline, occurring predominantly in subjects with baseline hypertension.
2 )] Gastrointestinal disorders: Dyspepsia, gastritis, abdominal distension Infections and Infestations: Sinusitis, rhinitis Investigations: GGT increased, AST increased, ALT increased, LDH increased Renal and urinary disorders: Nephrolithiasis, bladder pain Reproductive system and breast disorders: Vulvovaginal pruritus, vaginal infection Skin and subcutaneous tissue disorders: Urticaria, leukocytoclastic vasculitis, rash, pruritus, purpura, lip edema Table 9 lists the rates of the most commonly reported adverse reactions, derived from all adverse events in patients treated with mirabegron extended-release tablets 50 mg for up to 52 weeks in Study 4.
The most commonly reported adverse reactions (>3% of mirabegron extended-release tablets patients) were hypertension, urinary tract infection, headache, and nasopharyngitis. 4%). 2%). 3%) taking mirabegron extended-release tablets 50 mg; and these markers subsequently returned to baseline while both patients continued mirabegron extended-release tablets.
5% of patients treated with mirabegron extended-release tablets 50 mg, mirabegron extended-release tablets 100 mg, and active control once daily, respectively. Neoplasms reported by 2 patients treated with mirabegron extended-release tablets 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 mirabegron extended-release tablets 100 mg as well as an herbal medication (Kyufu Gold).
's MYRBETRIQ (mirabegron extended-release tablets). 's marketing exclusivity rights, this drug product is not labeled with that information. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of mirabegron extended-release tablets.
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: Cardiac disorders: Atrial fibrillation Gastrointestinal disorders: Nausea, constipation, diarrhea Nervous system disorders: Dizziness, headache 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.
2 )]
A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with mirabegron; however, mirabegron extended-release tablets should still be administered with caution to patients with clinically significant BOO.
For example, monitor these patients for signs and symptoms of urinary retention. 2 )] . 3 Angioedema Angioedema of the face, lips, tongue, and/or larynx has been reported with mirabegron extended-release tablets. 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. 2 )] . 4 Patients Taking Drugs Metabolized by CYP2D6 Since mirabegron extended-release tablet is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates is increased when coadministered with mirabegron extended-release tablet.
3 )] .