TRELEGY ELLIPTA

Linear pharmacokinetics was observed for fluticasone furoate (200 to 800 mcg), umeclidinium (62.5 to 500 mcg), and vilanterol (25 to 100 mcg). The pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol from TRELEGY ELLIPTA are comparable to the pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol when administered as fluticasone furoate/vilanterol or umeclidinium/vilanterol. Systemic drug levels [steady-state C max and AUC (0-24) ] of fluticasone furoate, umeclidi...

14.1 Chronic Obstructive Pulmonary Disease The clinical efficacy of TRELEGY ELLIPTA has been evaluated in 3 clinical trials in subjects with COPD, including chronic bronchitis and/or emphysema:

Trial 1(NCT01957163),

Trial 2(NCT02119286), and

Trial 3(NCT02164513). Trials 1 and 2 were multicenter, randomized, double-blind, parallel-group, 12-week treatment trials in subjects with COPD. Across both trials, a total of 412 subjects received coadministration of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg, the components of TRELEGY ELLIPTA. Comparative in vitro data (drug del...

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

• Serious Asthma-Related Events – Hospitalizations, Intubations, Death [see Warnings and Precautions ( 5.1 )]
• Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.4 )]
• Increased Risk of Pneumonia in COPD [see Warnings and Precautions ( 5.5 )]
• Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.6 )]
• Hypercorticism and Adrenal Suppression [see Warnings and Precautions (...

TRELEGY ELLIPTA is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] .
• Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, umeclidinium, vilanterol, or any of the excipients [see Warnings and Prec...

• LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 )
• Do not initiate in acutely deteriorating COPD or asthma. 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 )
• Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ...

7 DRUG INTERACTIONS

• Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and 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 ...