Glycopyrrolate And Formoterol Fumarate

1 INDICATIONS AND USAGE BEVESPI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions ( 5.1 , 5.2 )] . BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, 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 the relief of acute bronchospasm or for the treatment of asthma. ( 1 , 5.1 , 5.2 )

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail elsewhere in the labeling: • Paradoxical bronchospasm [see Warnings and Precautions (5.4) ] • Hypersensitivity reactions including Anaphylaxis [see Contraindications (4) , Warnings and Precautions (5.5) ] • Cardiovascular effects [see Warnings and Precautions (5.6) ] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.7) ] • Worsening of urinary retention [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥2% and more common than with placebo) include: urinary tract infection and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary There are no adequate and well-controlled trials of BEVESPI AEROSPHERE or its individual components, glycopyrrolate and formoterol fumarate, in pregnant women to inform a drug-associated risk. In animal reproduction studies, glycopyrrolate alone, administered by the subcutaneous route in rats and rabbits, did not cause structural abnormalities or affect fetal survival at exposures approximately 2700 and 5400 times from the maximum recommended human daily inhalation dose (MRHDID), respectively.

5 WARNINGS AND PRECAUTIONS • LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) • Do not initiate in acutely deteriorating COPD or to treat acute symptoms. ( 5.2 ) • Do not use in combination with an additional therapy containing a LABA because of risk of overdose. ( 5.3 , 7.1 ) • If paradoxical bronchospasm occurs, discontinue BEVESPI AEROSPHERE and institute alternative therapy. ( 5.4 ) • Use with caution in patients with cardiovascular disorders. ( 5.6 ) • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur. ( 5.7 ) • Worsening urinary retention may occur. 4 CONTRAINDICATIONS BEVESPI AEROSPHERE is contraindicated in: • use of a long-acting beta 2 -adrenergic agonist (LABA), including formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, without an inhaled corticosteroid, in patients with asthma [see Warnings and Precautions (5.1) ]. BEVESPI AEROSPHERE is not indicated for the treatment of asthma.