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TUDORZA for the long-term maintenance treatment of COPDSafety

Adverse reactions

Adverse reactions in placebo-controlled COPD clinical studies:

Adverse reactions occurring in the TUDORZA group at a frequency of ≥1% and
exceeding placebo*1

Adverse Reaction TUDORZA 400 mcg BID (n=636) n (%) Placebo (n=640) n (%)
Headache 42 (6.6) 32 (5.0)
Nasopharyngitis 35 (5.5) 25 (3.9)
Cough 19 (3.0) 14 (2.2)
Diarrhea 17 (2.7) 9 (1.4)
Sinusitis 11 (1.7) 5 (0.8)
Rhinitis 10 (1.6) 8 (1.2)
Toothache 7 (1.1) 5 (0.8)
Fall 7 (1.1) 3 (0.5)
Vomiting 7 (1.1) 3 (0.5)

Adverse Reaction

TUDORZA 400 mcg BID (n=636) n (%) 42 (6.6) 35 (5.5) 19 (3.0) 17 (2.7) 11 (1.7) 10 (1.6) 7 (1.1) 7 (1.1) 7 (1.1)
Placebo (n=640)
n (%)
32 (5.0) 25 (3.9) 14 (2.2) 9 (1.4) 5 (0.8) 8 (1.2) 5 (0.8) 3 (0.5) 3 (0.5)

*Pooled safety analysis from two 12-week and one 24-week placebo-controlled studies in patients with COPD.

  • The incidence of common anticholinergic adverse events was <1%, including dry mouth (0.8% vs 0.6%), constipation (0.0% vs 0.9%), and urinary retention (0.2% vs 0.0%), for TUDORZA vs placebo, respectively2
  • Fewer patients discontinued treatment with TUDORZA (n=29, 4.6%) due to adverse events compared to placebo (n=33, 5.1%)2
  • The adverse event most commonly leading to discontinuation was COPD exacerbation (1.9% for TUDORZA vs 2.5% for placebo)2

Long-term safety

  • TUDORZA PRESSAIR 400 mcg twice BID was assessed in 3 long-term safety studies, 2 double-blind and 1 open-label, ranging from 40 to 52 weeks in patients with moderate to severe COPD. The adverse events reported in the long-term safety studies were similar to those occurring in the placebo-controlled studies of 3 and 6 months1

Postmarketing experience

  • In postmarketing experience with TUDORZA PRESSAIR, immediate hypersensitivity reactions, including anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have been reported. Additionally, nausea, dysphonia, blurred vision, urinary retention, tachycardia and stomatitis have been observed1

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:

  • Prescribing Information for TUDORZA PRESSAIR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
  • Data on File, 3122907, AZPLP.