Trelegy Ellipta Description

TRELEGY ELLIPTA 100/62.5/25 mcg: Each single inhalation dispenses 100 mcg of fluticasone furoate, 62.5 mcg of umeclidinium (as bromide) and 25 mcg of vilanterol (as trifenatate). Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 mcg of fluticasone furoate, 55 mcg of umeclidinium (as bromide) and 22 mcg of vilanterol (as trifenatate), when tested under standardized in vitro conditions at a flow rate of 60 L/min for 4 seconds.
TRELEGY ELLIPTA 200/62.5/25 mcg: Each single inhalation dispenses 200 mcg of fluticasone furoate, 62.5 mcg of umeclidinium (as bromide) and 25 mcg of vilanterol (as trifenatate). Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 mcg of fluticasone furoate, 55 mcg of umeclidinium (as bromide) and 22 mcg of vilanterol (as trifenatate), when tested under standardized in vitro conditions at a flow rate of 60 L/min for 4 seconds.
In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min).
In adult subjects with very severe COPD (FEV₁/FVC [forced vital capacity] <70% and FEV₁ <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
TRELEGY ELLIPTA consists of an inhaler device with a plastic light grey body, a beige mouthpiece cover and a dose counter. The inhaler device encompasses two double foil blister strips both having 30 blisters each. On one strip, each blister contains a white dry powder mixture of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate. On the other strip, each blister contains a white dry powder mixture of micronized umeclidinium bromide (74.2 mcg, equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), lactose monohydrate and magnesium stearate. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.
Comparative in vitro data for drug delivery and aerodynamic particle size distribution of the delivered drugs fluticasone furoate (100 mcg), umeclidinium (62.5 mcg), and vilanterol (25 mcg) demonstrated that there were no pharmaceutical interactions and each drug was delivered in a comparable manner whether administered via a single ELLIPTA inhaler or from separate inhalers.
Non-medicinal Ingredients: Lactose monohydrate* (which contains milk protein) and magnesium stearate.
*See Contraindications and Precautions.