Daliresp: Advanced COPD Management with PDE4 Inhibition
| Product dosage: 500 mg | |||
|---|---|---|---|
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| 90 | $1.36 | $175.44 $122.12 (30%) | 🛒 Add to cart |
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| 180 | $1.05
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Daliresp (roflumilast) is a selective phosphodiesterase-4 (PDE4) inhibitor indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. As an oral maintenance treatment, it targets underlying inflammation rather than providing immediate bronchodilation, representing a distinct mechanism of action within the COPD therapeutic arsenal. Its use is reserved for specific patient phenotypes where its anti-inflammatory profile offers a strategic advantage in long-term disease management.
Features
- Contains roflumilast as the active pharmaceutical ingredient
- Selective phosphodiesterase-4 (PDE4) inhibitor mechanism
- 500 mcg tablet formulation
- Oral administration, once daily dosing
- Not indicated for relief of acute bronchospasm
- Requires prescription and medical supervision
Benefits
- Reduces frequency of moderate or severe COPD exacerbations
- Targets underlying airway inflammation in COPD
- Complements bronchodilator therapy without overlapping mechanisms
- Oral administration avoids inhaler technique dependencies
- May reduce systemic corticosteroid exposure through exacerbation prevention
- Suitable for long-term maintenance therapy in appropriate patient populations
Common use
Daliresp is specifically indicated to decrease the frequency of exacerbations or worsening of symptoms in patients with severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis and a history of exacerbations. It is not a bronchodilator and is not indicated for the relief of acute bronchospasm. The medication is prescribed as maintenance treatment in addition to bronchodilator therapy. Clinical use typically involves patients with severe airflow limitation (FEV1 < 50% predicted) who continue to experience exacerbations despite optimized bronchodilator treatment. Physicians may consider Daliresp particularly for patients with a chronic bronchitis phenotype characterized by chronic cough and sputum production.
Dosage and direction
The recommended dosage is one 500 mcg tablet taken orally once daily, with or without food. Administration should occur at approximately the same time each day to maintain consistent plasma concentrations. Tablets should be swallowed whole and not crushed, chewed, or broken. Treatment initiation typically follows a dose escalation period where 250 mcg is administered once daily for 4 weeks before increasing to the maintenance dose of 500 mcg daily. This titration strategy helps improve gastrointestinal tolerability. Patients should be advised that clinical benefit may not be immediately apparent, as the therapeutic effect develops over time through modulation of inflammatory pathways.
Precautions
Patients should be monitored for weight loss during treatment, as Daliresp has been associated with progressive weight decrease in some individuals. Regular weight measurement is recommended, with consideration of treatment discontinuation if unexplained or clinically significant weight loss occurs. Psychiatric events including insomnia, anxiety, nervousness, and depression have been reported; patients with pre-existing psychiatric conditions require careful monitoring. The medication is not recommended for patients with moderate to severe liver impairment (Child-Pugh B or C). Patients should be advised that Daliresp is not for treatment of acute bronchospasm and should not be used as rescue medication. Caution is advised when prescribing to patients with a history of gastrointestinal disorders, particularly those with underlying malabsorption conditions.
Contraindications
Daliresp is contraindicated in patients with severe hypersensitivity to roflumilast or any component of the product formulation. The medication is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C). Use is not recommended in patients under 18 years of age due to lack of safety and efficacy data in pediatric populations. The product is contraindicated in pregnancy unless the potential benefit justifies the potential risk to the fetus, as animal studies have demonstrated fetal harm. Nursing mothers should discontinue either nursing or the drug, taking into account the importance of the drug to the mother.
Possible side effects
The most common adverse reactions include diarrhea (9.5%), weight decrease (7.5%), nausea (4.7%), headache (4.4%), back pain (3.2%), influenza (2.8%), insomnia (2.4%), dizziness (2.1%), and decreased appetite (1.9%). Psychiatric disorders such as anxiety (1.4%) and depression (1.2%) may occur. Less frequent but potentially serious adverse effects include suicidal ideation and behavior. Gastrointestinal symptoms typically occur early in treatment and often resolve with continued therapy. Weight loss tends to be progressive and may require monitoring and potential intervention. Patients should report any mood changes, persistent gastrointestinal symptoms, or significant weight loss to their healthcare provider.
Drug interaction
Strong cytochrome P450 enzyme inducers such as rifampicin, phenobarbital, carbamazepine, and phenytoin may significantly decrease roflumilast exposure and reduce efficacy, requiring consideration of alternative therapy. Coadministration with oral corticosteroids may increase the risk of pneumonia, though this remains an area of ongoing investigation. The potential for interaction with systemic erythromycin and ketoconazole exists, though dose adjustment may not be necessary. Concurrent administration with theophylline requires careful monitoring due to overlapping PDE4 inhibition. While no clinically significant interactions have been observed with salmeterol or tiotropium, comprehensive interaction studies with all COPD medications remain limited.
Missed dose
If a dose is missed, patients should take it as soon as remembered on the same day. However, if the missed dose is not remembered until the next day, the patient should skip the missed dose and resume the regular dosing schedule. Patients should not take a double dose to make up for a missed dose. The long half-life of roflumilast (approximately 17 hours) and its mechanism of action involving gradual modulation of inflammatory pathways mean that occasional missed doses are unlikely to significantly impact therapeutic efficacy. However, consistent daily administration is recommended for optimal clinical outcomes.
Overdose
Experience with Daliresp overdose is limited. In clinical trials, doses up to 2500 mcg daily (five times the recommended dose) have been administered and were associated with increased incidence of adverse effects including headache, gastrointestinal disorders, dizziness, palpitations, and lightheadedness. There is no specific antidote for roflumilast overdose. Management should involve symptomatic and supportive care, including monitoring of vital signs and general supportive measures. Gastric lavage may be considered if performed soon after ingestion. Given the high protein binding of roflumilast, dialysis is unlikely to be effective. Medical toxicology consultation is recommended in cases of significant overdose.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep the medication in its original container with the lid tightly closed to protect from moisture and light. Do not store in bathroom cabinets where humidity levels may fluctuate. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Proper disposal of unused medication should follow local regulations, typically through medication take-back programs rather than flushing or household trash disposal.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made by qualified healthcare professionals based on individual patient circumstances. The prescribing physician should be familiar with the complete prescribing information and latest clinical data. Patients should not initiate or discontinue medication without consulting their healthcare provider. While every effort has been made to ensure accuracy, medical knowledge evolves rapidly and this information may not reflect the most current research or regulatory status.
Reviews
Clinical trials demonstrate that Daliresp reduces the rate of moderate or severe COPD exacerbations by approximately 17% compared to placebo in appropriate patient populations. Pulmonary specialists report value in specific patient phenotypes, particularly those with chronic bronchitis characteristics and frequent exacerbations despite optimized bronchodilator therapy. Many experts note that the benefit-risk profile requires careful patient selection and management of gastrointestinal side effects during treatment initiation. Real-world evidence suggests that appropriate patient education regarding expected onset of action and side effect management improves adherence and treatment success. The distinct mechanism of action provides a valuable addition to the COPD treatment paradigm, particularly for patients who continue to exacerbate on standard therapies.