From the Guidelines
Daliresp (Roflumilast) is a prescription medication used to reduce the frequency of flare-ups or exacerbations in people with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations. It works by inhibiting an enzyme called phosphodiesterase-4 (PDE4), which helps reduce inflammation in the lungs, as stated in the 2017 global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease report 1.
Key Points
- Daliresp is typically taken as a 500 mcg tablet once daily, with or without food.
- It's essential to note that Daliresp is not a rescue medication for sudden breathing problems and won't replace other COPD medications like bronchodilators.
- Instead, it's used as part of a comprehensive treatment plan to help prevent COPD flare-ups.
- Common side effects may include diarrhea, nausea, headache, back pain, decreased appetite, and weight loss, as mentioned in the 2015 American College of Chest Physicians and Canadian Thoracic Society guideline 1.
- Patients should be aware that Daliresp may cause psychiatric symptoms like depression, anxiety, and suicidal thoughts in some people, so any mood changes should be reported to a healthcare provider immediately.
Recommendations
- The 2017 European Respiratory Society/American Thoracic Society guideline suggests treatment with roflumilast to prevent future exacerbations in patients who have COPD with severe or very severe airflow obstruction, symptoms of chronic bronchitis, and exacerbations despite optimal inhaled therapy 1.
- Clinicians prescribing roflumilast need to advise their patients of the potential side effects of weight loss and diarrhea, and the decision to prescribe this medication should be informed by the fact that there are limited data for supplemental effectiveness in patients concurrently using inhaled therapies 1.
From the FDA Drug Label
Roflumilast tablet is a selective phosphodiesterase 4 inhibitor 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. Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm Roflumilast tablet is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations).
Daliresp (Roflumilast) is used to:
- Reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
- Decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations) in adults with severe Chronic Obstructive Pulmonary Disease (COPD). It is not indicated for the relief of acute bronchospasm 2 2.
From the Research
Daliresp (Roflumilast) Usage
- Daliresp (Roflumilast) is used for the management of chronic obstructive pulmonary disease (COPD) 3, 4, 5, 6, 7
- It is specifically used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations 3, 5, 7
- Roflumilast is an oral phosphodiesterase-4 (PDE-4) inhibitor that targets inflammatory cells involved in triggering COPD exacerbations 3, 4, 5, 6, 7
Patient Population
- Daliresp (Roflumilast) is effective in patients with moderate to severe COPD, particularly those with chronic bronchitis, frequent exacerbations, or who require frequent rescue inhaler therapy 3, 4, 5, 6, 7
- It is also effective in patients with severe COPD who have a history of frequent exacerbations 5, 7
Administration and Dosage
- Roflumilast is available in 500-μg tablets to be administered once daily 3, 5, 7
- It can be used as monotherapy or in combination with other treatments such as long-acting β2-agonist (LABA) therapy, long-acting β(2)-agonists, or anticholinergic agents 3, 7
Efficacy and Safety
- Roflumilast has been shown to improve lung function and reduce COPD exacerbations in clinical trials 3, 4, 5, 6, 7
- The most common adverse events associated with roflumilast are diarrhea, nausea, and headache 3, 4, 5, 6, 7
- Roflumilast has also been associated with an increased risk of psychiatric events and weight loss 3, 4, 6, 7