Azelastine and fluticasone and Umeclidinium and vilanterol interaction
Azelastine and fluticasone and Umeclidinium and vilanterol: the Umeclidinium and vilanterol prescribing label flags this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.
Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.
What the FDA labels say
From the Umeclidinium and vilanterol (Umeclidinium and Vilanterol Ellipta) label · effective 2024-11-22
…conditions, non-fatal myocardial infarction, non-fatal acute myocardial infarction, and adjudicated on-treatment death due to cardiovascular events, was 2.2 per 100 patient-years for fluticasone furoate/umeclidinium/vilanterol 100/62.5/25 mcg (n = 4,151), 1.9 per 100 patient-years for fluticasone furoate/vilanterol 100/25 mcg (n = 4,134), and 2.2 per 100 patient-years…
Adjudicated on‑treatment deaths due to cardiovascular events occurred in 20 of 4,151 patients (0.54 per 100 patient-years) receiving fluticasone furoate/umeclidinium/vilanterol, 27 of 4,134 patients (0.78 per 100 patient-years) receiving fluticasone furoate/vilanterol, and 16 of 2,070 patients (0.94 per 100 patient-years) receiving umeclidinium and vilanterol…
• use of a long-acting beta 2 -adrenergic agonist (LABA), including vilanterol, one of the active ingredients in Umeclidinium and Vilanterol ELLIPTA, without an inhaled corticosteroid (ICS), in patients with asthma [see Warnings and Precautions ( 5.1 )] .
• Use of a LABA, including Umeclidinium and Vilanterol ELLIPTA, without an inhaled corticosteroid is contraindicated in patients with asthma.
• LABA monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events.
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