From the Guidelines
Roflumilast is a medication used to treat severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis in adults who have frequent exacerbations, typically prescribed as a 500 microgram tablet taken once daily. Roflumilast works by reducing inflammation in the lungs, as a phosphodiesterase-4 (PDE4) inhibitor, which helps prevent the breakdown of cyclic AMP, a molecule that plays a role in reducing inflammation 1. By maintaining higher levels of cyclic AMP, roflumilast helps decrease inflammation in the airways, reducing COPD symptoms and exacerbations.
It's essential to note that roflumilast is not a rescue medication and should not be used for acute bronchospasm, but rather as a maintenance treatment 2. Patients should continue their other COPD medications as prescribed by their doctor. Common side effects may include diarrhea, weight loss, and nausea, and patients should be monitored for changes in weight and mood, as depression and suicidal thoughts have been reported in some cases 3.
The use of roflumilast is recommended in patients with severe or very severe airflow obstruction, symptoms of chronic bronchitis, and exacerbations despite optimal inhaled therapy, to prevent future exacerbations 4. The medication has been shown to decrease the number of moderate or severe exacerbations per patient-year and increase time to next exacerbation 1. However, it's crucial to weigh the benefits against the potential side effects and consider the individual patient's needs and medical history.
Key points to consider when prescribing roflumilast include:
- Patient selection: severe COPD with chronic bronchitis and frequent exacerbations
- Dosage: 500 microgram tablet taken once daily
- Side effects: diarrhea, weight loss, nausea, and potential mood changes
- Concomitant therapy: continue other COPD medications as prescribed
- Monitoring: regular follow-up to assess efficacy and tolerability.
From the FDA Drug Label
Roflumilast tablet 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. 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).
Roflumilast is used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It is not a bronchodilator and should not be used for treating sudden breathing problems. [5] [6]
From the Research
Roflumilast Usage
Roflumilast is used for the treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations 7, 8, 9, 10, 11.
Key Indications
- Maintenance treatment of severe COPD (FEV1 postbronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment 7
- Reduction of exacerbations in patients with severe COPD, especially those with chronic bronchitis, frequent exacerbations, or who require frequent rescue inhaler therapy 7, 8, 9, 10, 11
Benefits
- Improves lung function and reduces exacerbations in patients with severe COPD 7, 8, 9, 10, 11
- Offers an oral tablet formulation with once-daily dosing, providing an alternative to inhaler therapy 7
- Can be used as an add-on to bronchodilator treatment or as an alternative to other COPD medications 8, 9, 10, 11