ANORO ELLIPTA

Linear pharmacokinetics was observed for umeclidinium (62.5 to 500 mcg) and vilanterol (25 to 100 mcg).

AbsorptionUmeclidinium: Umeclidinium plasma levels may not predict therapeutic effect. Following inhaled administration of umeclidinium in healthy subjects, C max occurred at 5 to 15 minutes. Umeclidinium is mostly absorbed from the lung after inhaled doses with minimum contribution from oral absorption. Following repeat dosing of inhaled ANORO ELLIPTA, steady state was achieved within 14 day...

The safety and effectiveness of ANORO ELLIPTA were evaluated in a clinical development program that included 6 dose-ranging trials, 4 lung function trials of 6 months’ duration (2 placebo controlled and 2 active controlled), two 12-week crossover trials, and a 12-month long‑term safety trial. The efficacy of ANORO ELLIPTA is based primarily on the dose-ranging trials in 1,908 subjects with COPD or asthma [see Clinical Studies ( 14.1 )] and the 2 placebo-controlled confirmatory trials, with additional support from the 2 active-controlled and 2 crossover trials in 5,388 subjects with COPD, inclu...

The following clinically significant adverse reactions are described elsewhere in labeling:

• Serious asthma-related events–hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )]
• Paradoxical bronchospasm [see Warnings and Precautions ( 5.5 )]
• Cardiovascular effects [see Warnings and Precautions ( 5.7 )]
• Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.9 )]
• Worsening of urinary retention [see Warnings and Precautions ( 5.10 )] Most common adverse r...

ANORO ELLIPTA is contraindicated in:

• patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients [see Warnings and Precautions (5.6), Description (11)] .
• use of a long-acting beta 2 -adrenergic agonist (LABA), including vilanterol, one of the active ingredients in ANORO ELLIPTA, without an inhaled cortic...

• LABA monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 )
• Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms. ( 5.2 )
• Do not use in combination with additional therapy containing a LABA because of risk of overdose. ( 5.3 )
• If paradoxical bronchospasm occurs, discontinue ANORO ELLIPTA and institute alternative therapy. ( 5.5 )
• Use with caution in patients with cardiovascular disorders becau...

7 DRUG INTERACTIONS

• Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause cardiovascular effects. ( 7.1 )
• Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on cardiovascular system. ( 7.2 )
• Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce se...