![]() ![]() Advise patients to rinse their mouths with water without swallowing after inhalation. Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate.Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA. TRELEGY should not be used more often or at higher doses than recommended or with another LABA for any reason, as an overdose may result.Acute symptoms should be treated with an inhaled, short-acting beta 2-agonist. TRELEGY is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms.TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.TRELEGY is not indicated for use in pediatric patients aged 17 years and younger. When LABA are used in fixed-dose combination with inhaled corticosteroids (ICS), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. These findings are considered a class effect of LABA monotherapy. Long-acting beta 2-adrenergic agonist (LABA) monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization.Patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients.Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required. ![]() TRELEGY is contraindicated in the following: ![]()
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