Indications and Usage
DALIRESP (roflumilast) 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 is not a
bronchodilator and is not indicated for the relief of acute bronchospasm.
Important Safety Information
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.
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%).
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