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Indication-OnPage-MAX
Indication-OnPage-MIN
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-Sticky-MIN
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.
It’s easy. Here’s how it works:
You are now leaving VEOZAH.com. The third-party website you are linking to is neither owned nor controlled by Astellas. Astellas is not responsible for the content or services on this site. The third-party website is subject to its own Terms of Use and Privacy Policy.
Astellas makes no representations as to the accuracy of the information contained on third-party websites. By clicking CONTINUE, you acknowledge that Astellas does not endorse or recommend any HCP associated with the third-party website, nor do we make any representations about the quality of medical care those professionals can provide.
Astellas makes no guarantee that using the third-party website will result in the outcome you desire. The physician has no obligation to prescribe VEOZAH and may instead prescribe another medication or no medication. It is wholly and solely your responsibility to assess the qualifications of a potential healthcare professional, and to discuss with them your symptoms as well as the risks and benefits of any potential treatment. You are responsible for any charges associated with services offered by the third-party website and should be aware that the third party may not accept medical insurance. ASTELLAS AND ITS AFFILIATES DISCLAIM ANY LIABILITY ARISING FROM YOUR USE AND/OR RELIANCE ON INFORMATION PROVIDED TO YOU BY ANY HEALTHCARE PROFESSIONAL OR THE THIRD-PARTY WEBSITE.
Note: The cost of a telehealth consultation is determined by and paid directly to the third-party telehealth company.
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MAT_ABC_NON_2024_00086 Date of issue of Certificate [28/04/2023]
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