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IMPORTANT SAFETY INFORMATION

Contraindications

DALIRESP® (roflumilast) is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Warnings and Precautions

For reducing the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations

DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm

Before one exacerbation can lead to another,1

Before one exacerbation can lead to another,1
Add DALIRESP

Before one exacerbation can lead to another,1
Add DALIRESP

The first and only once-daily tablet to provide enhanced protection against COPD exacerbations*2

  • DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DALIRESP® (roflumilast) is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

  • DALIRESP (roflumilast) is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

*In the two 1-year pivotal studies, DALIRESP was added to bronchodilators, including long-acting β2 agonists (LABAs), or short-acting muscarinic antagonists (SAMAs), and short-acting β2 agonists (SABAs).

 

IMPORTANT SAFETY INFORMATION

Contraindications

DALIRESP® (roflumilast) is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Warnings and Precautions

  • DALIRESP is not a bronchodilator and should not be used for the relief of acute bronchospasm

  • Prescribers should advise patients, their caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur, to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment if such events occur. Before using DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with DALIRESP

    • Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions.
      In controlled clinical trials 5.9% of patients treated with DALIRESP reported psychiatric adverse reactions vs 3.3% treated with placebo. The most common psychiatric adverse reactions were insomnia (2.4% vs 1.0%), anxiety (1.4% vs 0.9%), and depression (1.2% vs 0.9%). Three patients treated with DALIRESP experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) compared to one patient (suicidal ideation) treated with placebo

  • Patients should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated and treatment discontinuation considered

    • In addition to weight loss being reported as a common adverse reaction (7.5% of patients treated with DALIRESP vs 2.1% placebo), weight was prospectively assessed in two 1-year clinical trials. In these studies that compared DALIRESP to placebo, 20% vs 7% experienced moderate weight loss (5-10% of body weight) and 7% vs 2% experienced severe weight loss (>10% body weight). During the follow-up period after discontinuing DALIRESP, the majority of patients regained some of the weight they had lost

  • Use with strong cytochrome P450 enzyme inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended, as they decrease the exposure and may reduce the therapeutic effectiveness of DALIRESP

Adverse Reactions

In clinical trials, the most common adverse reactions (≥2% and greater than placebo) were diarrhea (9.5% vs 2.7%), weight loss (7.5% vs 2.1%), nausea (4.7% vs 1.4%), headache (4.4% vs 2.1%), back pain (3.2% vs 2.2%), influenza (2.8% vs 2.7%), insomnia (2.4% vs 1.0%), dizziness (2.1% vs 1.1%), and decreased appetite (2.1% vs 0.4%).

INDICATION AND USAGE

DALIRESP® (roflumilast) is indicated as a treatment to reduce the risk of Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm.


Please see full Prescribing Information, including Medication Guide.


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:

  1. Hurst JR, Donaldson GC, Quint JK, Goldring JJP, Baghai-Ravary R, Wedzicha JA. Temporal clustering of exacerbations in chronic obstructive pulmonary disease. AM J Respir Crit Care Med. 2009;179:369-374.

  2. DALIRESP Prescribing Information. Wilmington, DE; AstraZeneca Pharmaceuticals LP; November 2015.