Umeclidinium Bromide And Vilanterol Trifenatate

1 INDICATIONS AND USAGE Umeclidinium and Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use Umeclidinium and Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of Umeclidinium and Vilanterol ELLIPTA in asthma have not been established. Umeclidinium and Vilanterol ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 ) Limitations of Use: Not indicated for relief of acute bronchospasm or for the treatment of asthma. ( 1 , 5.2 )

6 ADVERSE REACTIONS 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 reactions (incidence ≥1% and more common than placebo) are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.

8.1 Pregnancy Risk Summary There are insufficient data on the use of umeclidinium and vilanterol ELLIPTA or its individual components, umeclidinium and vilanterol, in pregnant women to inform a drug-associated risk. (See Clinical Considerations.) In animal reproduction studies, umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effects on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (MRHDID).

5 WARNINGS AND PRECAUTIONS • 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 Umeclidinium and Vilanterol ELLIPTA and institute alternative therapy. ( 5.5 ) • Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation. ( 5.7 ) • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. ( 5.8 ) • Worsening of narrow-angle glaucoma may occur. 4 CONTRAINDICATIONS Umeclidinium and Vilanterol 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 )] .