BEVESPI AEROSPHERE

Linear pharmacokinetics were observed for glycopyrrolate (dose range: 18 to 144 mcg) and formoterol fumarate (dose range: 2.4 to 19.2 mcg) after oral inhalation.

AbsorptionGlycopyrrolate: Following inhaled administration of BEVESPI AEROSPHERE in subjects with COPD, C max occurred at 5 minutes. Steady state is expected to be achieved within 2-3 days of repeated dosing of BEVESPI AEROSPHERE and the extent of exposure is approximately 2.3 times higher than after the first dose. Formoterol Fumarate...

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical program for BEVESPI AEROSPHERE included 4,911 subjects with COPD in two 24-week lung function trials, one long-term safety extension study of 28 weeks, and 10 other trials of shorter duration. A total of 1,302 subjects have received at least 1 dose of BEVESPI AEROSPHERE. The safety data de...

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 re...

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.
• patients with hypersensitivity to glycopyrrolate, f...

• 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 disorde...

7 DRUG INTERACTIONS No formal drug interaction studies have been performed with BEVESPI AEROSPHERE.

• Other adrenergic drugs may potentiate effect: Use with caution ( 5.3 , 7.1 )
• Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 7.2 , 7.3 )
• Diuretics: Use with caution. Electrocardiographic changes and/or ...