Comment
Author: Admin | 2025-04-28
Of TRELEGY, (and placebo + FF/VI) were: headache, 4% (3%); back pain, 4% (2%); dysgeusia, 2% ( Additional adverse reactions (≥1% incidence) reported in subjects with COPD taking TRELEGY in a 52-week trial included upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia. ADVERSE REACTIONS: TRELEGY FOR ASTHMA In subjects with asthma, the most common adverse reactions (≥2% incidence with TRELEGY) reported in a 24-week to 52-week clinical trial with: TRELEGY 100/62.5/25 mcg (or FF/VI 100/25 mcg) were: pharyngitis/nasopharyngitis, 17% (16%); headache, 9% (7%); upper respiratory tract infection/viral upper respiratory tract infection, 5% (7%); respiratory tract infection/viral respiratory tract infection, 4% (4%); bronchitis, 4% (3%); influenza, 4% (3%); back pain, 3% (4%); sinusitis/acute sinusitis, 2% (3%); rhinitis, 2% (3%). TRELEGY 200/62.5/25 mcg (or FF/VI 200/25 mcg) were: pharyngitis/nasopharyngitis, 15% (16%); upper respiratory tract infection/viral upper respiratory tract infection, 7% (6%); headache, 5% (6%); bronchitis, 5% (5%); sinusitis/acute sinusitis, 3% (2%); respiratory tract infection/viral respiratory tract infection, 3% (2%); back pain, 2% (1%); urinary tract infection, 2% ( DRUG INTERACTIONS TRELEGY should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system. Use beta‐blockers with caution, as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD or asthma. Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists. Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects. USE IN SPECIFIC POPULATIONS TRELEGY is not indicated for use in children and adolescents. The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established. Use TRELEGY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects. Please see full Prescribing Information, including Patient Information, for TRELEGY.
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