Safety And Adverse Reactions

Use twice a day for the maintenance treatment of COPD

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)

*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 months.1

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 observed.1

Important Safety Information

  • TUDORZA PRESSAIR 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 prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any worsening of glaucoma or worsening of urinary retention 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. In a long-term cardiovascular safety trial of up to 3 years, the adverse reactions (occurring at a rate of ≥2% and more common than placebo) were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease

INDICATIONS AND USAGE

Tudorza® Pressair® (aclidinium bromide inhalation powder) is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

TUDORZA is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

Please also see the full Prescribing Information, including Patient Information.

ADVERSE REACTIONS

You are encouraged to report any TUDORZA adverse events by calling 1-800-236-9933 or by clicking here. If you prefer to report these to the FDA, either visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Who should not use TUDORZA PRESSAIR?
TUDORZA PRESSAIR is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to aclidinium bromide or any of the excipients

Important Safety Information

  • TUDORZA PRESSAIR 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 prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any worsening of glaucoma or worsening of urinary retention 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. In a long-term cardiovascular safety trial of up to 3 years, the adverse reactions (occurring at a rate of ≥2% and more common than placebo) were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease

INDICATIONS AND USAGE

Tudorza® Pressair® (aclidinium bromide inhalation powder) is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

TUDORZA is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

Please also see the full Prescribing Information, including Patient Information.

ADVERSE REACTIONS

You are encouraged to report any TUDORZA adverse events by calling 1-800-236-9933 or by clicking here. If you prefer to report these to the FDA, either visit www.fda.gov/medwatch or call 1-800-FDA-1088.

REFERENCES: 1. Tudorza® Pressair® (aclidinium bromide inhalation powder) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Kerwin EM, D’Urzo AD, Gelb AF, et al; on behalf of the ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012;9:90-101.