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TUDORZA for the long-term maintenance treatment of COPDCOPD Facts

INTRODUCTION Chronic obstructive pulmonary disease is a progressive lung disease characterized by airflow limitation. COPD is often associated with chronic inflammation of the lungs and airways in response to irritants such as noxious particles or gases.1

US Prevalence

The prevalence of COPD is increasing.2 Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the US.3 Approximately 15 million adult Americans have been diagnosed with COPD, and it is estimated that an additional 12 million remain undiagnosed.4

5 US states with the highest prevalence of COPD*2:

5 US States with the Highest Prevalence of COPD 5 US States with the Highest Prevalence of COPD

*Based on the 2011 Behavioral Risk Factor Surveillance System (BRFSS). Prevalence age-adjusted to the 2000 US standard population aged ≥ 18 years.

At-Risk Groups

COPD typically occurs in people age 40 and above1; prevalence generally increases with age.2,5

  •  
  • The prevalence of COPD is higher in women than in men2,5
 

Prevalence of COPD within different ethnicities*2:

  • 6.3% White, non-Hispanic
  • 6.1% Black, non-Hispanic
  • 4.0% Hispanic
  • 5.8% Other/non-Hispanic

*Based on the 2011 Behavioral Risk Factor Surveillance System (BRFSS). Prevalence age-adjusted to the 2000 US standard population aged ≥ 18 years.

 

Primary Cause6,7

  •  
  • ~85-90% of COPD cases caused by smoking
 

Other risk factors include:

  • Indoor air pollution
  • Outdoor air pollution
  • Occupational dusts and chemicals
  • Secondhand smoke
 
 

IMPORTANT SAFETY INFORMATION

  • TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to aclidinium bromide or any of the excipients
  • TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy)
  • Immediate hypersensitivity reactions, including anaphylaxis, angioedema (swelling of lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have occurred after administration of TUDORZA PRESSAIR. Additionally, inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If any of these occurs, treatment with TUDORZA PRESSAIR should be stopped and other treatments considered
  • TUDORZA PRESSAIR should be used with caution in patients with narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of acute narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop
  • The most common adverse reactions (≥3% incidence and greater than placebo) were headache (6.6% vs 5.0%), nasopharyngitis (5.5% vs 3.9%), and cough (3.0% vs 2.2%), for TUDORZA PRESSAIR vs placebo, respectively

INDICATIONS AND USAGE

TUDORZA PRESSAIR is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Please also see the full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
  
 
 
 

References:

  • Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. http://www.goldcopd.org/uploads/users/files/WatermarkedGlobal%20Strategy%202016(1).pdf. Updated 2016. Accessed April 7, 2016.
  • Centers for Disease Control and Prevention. Chronic Obstructive Pulmonary Disease Among Adults – United States, 2011. MMWR. Nov 2012;61(46);938-943. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6146a2.htm?s_cid=mm6146a2_w. Accessed April 7, 2016.
  • Centers for Disease Control and Prevention. Deaths: Final Data for 2013. National Vital Statistics Reports. 2016;62(2). http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf. Published February 16, 2016. Accessed April 7, 2016.
  • National Heart, Lung, and Blood Institute (NHLBI). Morbidity & Mortality: 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. http://www.nhlbi.nih.gov/files/docs/research/2012_ChartBook_508.pdf. Published February 2012. Accessed April 7, 2016.
  • Ford ES, Croft JB, Mannino DM, Wheaton AG, Zhang X, Giles WH. COPD Surveillance–United States, 1999-2011. CHEST. 2013;144(1):284–305.
  • American Lung Association. What Causes COPD. http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/symptoms-causes-risk-factors/what-causes-copd.html. Published 2016. Accessed April 7, 2016.
  • World Health Organization. Causes of COPD. http://www.who.int/respiratory/copd/causes/en/#. Accessed April 7, 2016.