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Indication body title
BRAND® (common name), either alone or in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.
WARNING: SYNDROME
Patients treated with BRAND® (common name) have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If syndrome is suspected, initiate therapy and monitoring until symptom resolution.
BRAND® (common name) is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet.
BRAND monotherapy or in combination with solifenacin succinate can increase blood pressure in adults. Periodic blood pressure determinations are recommended, especially in hypertensive patients. BRAND is not recommended for use in patients with severe uncontrolled hypertension (defined as systolic blood pressure ≥ 180mm Hg and/or diastolic blood pressure ≥ 110mm Hg). Worsening of pre-existing hypertension was reported infrequently in patients taking BRAND
Since BRAND is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates is increased when co‐administered with BRAND. Therefore, appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6.
In clinical trials, the most commonly reported adverse reactions in adults (> 2% and > placebo) for BRAND 25mg and 50mg versus placebo, respectively, were hypertension (11.3%, 7.5% vs. 7.6%), nasopharyngitis (3.5%, 3.9% vs. 2.5%), urinary tract infection (4.2%, 2.9% vs. 1.8%), and headache (2.1%, 3.2% vs. 3.0%).
In clinical trials, the most commonly reported adverse reactions in adults (> 2% and > placebo and > comparator) for BRAND in combination with solifenacin succinate 25mg + 5mg and 50mg + 5mg versus BRAND 25mg, BRAND 50mg, solifenacin succinate 5mg, and placebo, respectively, were dry mouth (9.3%, 7.2% vs. 3.8%, 3.6%, 6.5%, 2.2%), urinary tract infection (7.0%, 4.0% vs. 4.0%, 4.2%, 3.6%, 5.3%), constipation (4.2%, 3.9% vs. 1.2%, 2.8%, 2.4%, 1.2%), and tachycardia (2.2%, 0.9% vs. 1.6%, 1.6%, 0.7%, 0.8%).
In postmarketing experience with mirabegron, the following events have also occurred: atrial fibrillation, nausea, diarrhea, and dizziness.
Please refer to prescribing information for solifenacin succinate when prescribing BRAND in combination with solifenacin succinate.
Indication body title
BRAND® (common name), either alone or in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.
WARNING: SYNDROME
Patients treated with BRAND® (common name) have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If syndrome is suspected, initiate therapy and monitoring until symptom resolution.
BRAND® (common name) is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet.
BRAND monotherapy or in combination with solifenacin succinate can increase blood pressure in adults. Periodic blood pressure determinations are recommended, especially in hypertensive patients. BRAND is not recommended for use in patients with severe uncontrolled hypertension (defined as systolic blood pressure ≥ 180mm Hg and/or diastolic blood pressure ≥ 110mm Hg). Worsening of pre-existing hypertension was reported infrequently in patients taking BRAND
Since BRAND is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates is increased when co‐administered with BRAND. Therefore, appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6.
In clinical trials, the most commonly reported adverse reactions in adults (> 2% and > placebo) for BRAND 25mg and 50mg versus placebo, respectively, were hypertension (11.3%, 7.5% vs. 7.6%), nasopharyngitis (3.5%, 3.9% vs. 2.5%), urinary tract infection (4.2%, 2.9% vs. 1.8%), and headache (2.1%, 3.2% vs. 3.0%).
In clinical trials, the most commonly reported adverse reactions in adults (> 2% and > placebo and > comparator) for BRAND in combination with solifenacin succinate 25mg + 5mg and 50mg + 5mg versus BRAND 25mg, BRAND 50mg, solifenacin succinate 5mg, and placebo, respectively, were dry mouth (9.3%, 7.2% vs. 3.8%, 3.6%, 6.5%, 2.2%), urinary tract infection (7.0%, 4.0% vs. 4.0%, 4.2%, 3.6%, 5.3%), constipation (4.2%, 3.9% vs. 1.2%, 2.8%, 2.4%, 1.2%), and tachycardia (2.2%, 0.9% vs. 1.6%, 1.6%, 0.7%, 0.8%).
In postmarketing experience with mirabegron, the following events have also occurred: atrial fibrillation, nausea, diarrhea, and dizziness.
Please refer to prescribing information for solifenacin succinate when prescribing BRAND in combination with solifenacin succinate.
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MAT_ABC_NON_2024_00086 Date of issue of Certificate [28/04/2023]
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