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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

To reduce 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 COPD exacerbation can lead to another,1

Before one COPD exacerbation can lead to another,1
ADD DALIRESP*

Before one COPD exacerbation can lead to another,1
ADD DALIRESP*

for enhanced exacerbation protection2

SIGNIFICANTLY REDUCED THE RATE OF MODERATE OR SEVERE EXACERBATIONS WHEN ADDED TO CURRENT BRONCHODILATOR THERAPY3*

  • In the two 1-year pivotal studies, DALIRESP 500 mcg significantly reduced the mean rate of moderate or severe exacerbations by 17% vs placebo (P=0.0003)3

  • Mean rate of moderate or severe exacerbations per patient per year was 1.14 for DALIRESP + bronchodilators* vs 1.37 for placebo + bronchodilators* (P=0.0003)3

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

*In the two 1-year pivotal studies, patients were allowed to be on long-acting β2 agonist (LABA) or short-acting muscarinic antagonist (SAMA) at stable doses. Short-acting β2 agonists (SABA) was allowed for rescue use. In the pooled analysis, the use of concomitant bronchodilators in the placebo group vs DALIRESP group were: LABA (51% vs 49%), SAMA (37% vs 35%), and SABA (99% vs 100%).

Moderate exacerbations were defined as those requiring treatment with systemic corticosteroids, and severe exacerbations were defined as those resulting in hospitalization or death.

A NEW 250-MCG STARTING DOSE

An option for the first 4 weeks. Not a therapeutic dose.2Tablet image is a representation and not actual size.

VIEW DOSING »

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 8 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 in these studies 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. In an additional placebo-controlled 1-year clinical trial (Trial 9), which assessed the effect of DALIRESP when added to a fixed-dose combination of an inhaled corticosteroid and long-acting beta agonist, one patient completed suicide while receiving DALIRESP

  • 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 pivotal 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 8 controlled 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%). The safety profile of DALIRESP in Trial 9 was consistent with the key pivotal studies.

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.

Limitations of Use

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

  • DALIRESP 250 mcg is a starting dose for the first 4 weeks of treatment only and is not the effective (therapeutic) dose


Please see full Prescribing Information, including Medication Guide.


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References:

  1. Hurst JR, Donaldson GC, Quint JK, Goldring JJ, 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® (roflumilast) [prescribing information]. Wilmington. DE: AstraZeneca Pharmaceuticals LP; January 2018.

  3. Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 Study Groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009;374:685-694.