Daliresp

Daliresp (roflumilast) is a selective phosphodiesterase-4 (PDE4) 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. It represents a distinct class of maintenance therapy that targets underlying inflammation, not merely symptom relief. By modulating inflammatory pathways, Daliresp offers a novel mechanism for long-term disease modification in appropriate patient populations, complementing existing bronchodilator therapies.

Features

• Active ingredient: Roflumilast 500 mcg
• Pharmaceutical form: Film-coated tablet
• Mechanism: Selective inhibition of phosphodiesterase-4 (PDE4)
• Prescription status: Rx-only
• Packaging: Blister packs of 10, 30, or 90 tablets

Benefits

• Reduces frequency of moderate-to-severe COPD exacerbations
• Targets underlying airway inflammation rather than only providing symptomatic relief
• Does not interact with cytochrome P450 system, minimizing pharmacokinetic drug interactions
• Convenient once-daily dosing supports adherence
• May help preserve lung function over time in indicated populations
• Non-steroidal anti-inflammatory mechanism avoids corticosteroid-related side effects

Common use

Daliresp is prescribed as maintenance treatment in patients with severe Chronic Obstructive Pulmonary Disease (COPD) (post-bronchodilator FEV₁/FVC <0.7 and FEV₁ <50% predicted) associated with chronic bronchitis, particularly those with a history of frequent exacerbations. It is not indicated for the relief of acute bronchospasm and should not be used as rescue medication. Clinical trials demonstrate particular efficacy in patients with chronic cough and sputum production who experience repeated exacerbations requiring antibiotics or systemic corticosteroids.

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 steady plasma concentrations. Tablets should be swallowed whole and not crushed, chewed, or broken. Dose titration is not required when initiating therapy. No dosage adjustment is necessary for elderly patients or those with mild-to-moderate hepatic impairment. Treatment response should be evaluated periodically, with continued therapy based on exacerbation reduction benefit versus tolerability.

Precautions

Patients should be monitored for weight loss during treatment, as Daliresp is associated with dose-dependent weight decrease. Regular weight monitoring is recommended, with consideration of discontinuation if unexplained or clinically significant weight loss occurs. Psychiatric events including insomnia, anxiety, and depression have been reported; patients with pre-existing depression should be monitored closely. Use with caution in patients with moderate hepatic impairment (Child-Pugh B); not recommended in severe impairment (Child-Pugh C). Not for use in patients under 18 years of age.

Contraindications

Daliresp is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Concomitant use with strong cytochrome P450 enzyme inducers (such as rifampicin, phenobarbital, carbamazepine, phenytoin) is contraindicated due to significantly reduced roflumilast exposure. History of hypersensitivity to roflumilast or any component of the formulation. Not recommended during pregnancy unless potential benefit justifies potential risk to fetus.

Possible side effects

Most common adverse reactions (≥2% and greater than placebo) 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 (2.1%). Less frequent but clinically significant effects may include psychiatric disorders (depression, anxiety), gastrointestinal symptoms, and rash. Side effects often occur early in treatment and may diminish with continued therapy.

Drug interaction

Strong CYP450 inducers (rifampicin, phenobarbital, carbamazepine, phenytoin) significantly decrease roflumilast exposure and are contraindicated. Coadministration with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast exposure by approximately 38%. No clinically significant interactions with CYP450 inhibitors. No expected interactions with common COPD medications including short-acting and long-acting bronchodilators, corticosteroids, or theophylline.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If missed entirely for that day, the patient should resume the regular dosing schedule the following day. Do not double the dose to make up for a missed dose. Consistent daily administration is important for maintaining therapeutic effect.

Overdose

Limited experience with overdose. Single doses up to 2500 mcg have been administered without significant adverse effects. In case of suspected overdose, symptomatic and supportive treatment is recommended. Roflumilast is not dialyzable due to high protein binding. Monitor for gastrointestinal effects and provide appropriate supportive care.

Storage

Store at room temperature (20-25°C/68-77°F) with excursions permitted between 15-30°C (59-86°F). Keep in original container to protect from moisture and light. Keep out of reach of children. Do not use after expiration date printed on packaging.

Disclaimer

This information is provided for educational purposes only and does not replace professional medical advice. Treatment decisions should be made in consultation with a qualified healthcare provider based on individual patient characteristics. The prescriber should be familiar with the complete prescribing information and latest clinical guidelines for COPD management.

Reviews

Clinical trials demonstrate Daliresp reduces moderate-to-severe exacerbation rates by approximately 17% compared to placebo in severe COPD patients with chronic bronchitis history. Pulmonary specialists report particular value in frequent exacerbators despite optimal bronchodilator therapy. Real-world evidence suggests best outcomes in motivated patients with adequate education about expected therapeutic onset (typically several weeks) and management of transient gastrointestinal side effects. Patient-reported outcomes indicate satisfaction with reduced exacerbation frequency despite initial adjustment period.