Medication Counseling Points for Daliresp (Roflumilast) Oral Tablets
Patients must understand that Daliresp is NOT a rescue inhaler and will not provide immediate relief of breathing problems—they must keep their rescue inhaler available at all times. 1
Critical Safety Warnings
Psychiatric Effects and Suicide Risk
Counsel patients, families, and caregivers to immediately report any new or worsening mood changes, including:
- Suicidal thoughts or behaviors (including completed suicides reported post-marketing)
- New or worsening depression
- New or worsening anxiety
- Insomnia or sleep disturbances
- Acting on dangerous impulses
- Any unusual behavioral changes 1
The risk-benefit ratio must be carefully reconsidered in patients with a history of depression or suicidal ideation. These psychiatric events can occur even in patients without prior psychiatric history.
Weight Loss Monitoring
Patients should monitor their weight regularly (ideally weekly initially, then monthly). 1
- Average weight loss in clinical trials was approximately 2.1 kg 2
- Weight loss is most common in the first 3-4 weeks of therapy 2
- Unexplained or excessive weight loss requires immediate provider notification and may necessitate discontinuation
- Most patients regain some weight after stopping the medication 1
Appropriate Patient Population
Daliresp is specifically indicated for patients with:
- Moderate to severe COPD (FEV₁ <50% predicted) 2, 3
- Chronic bronchitis phenotype 2
- History of at least one exacerbation in the previous year requiring treatment or hospitalization 2
This medication reduces COPD exacerbations but does NOT replace bronchodilators or provide symptom relief. 1
Common Side Effects
Warn patients about expected gastrointestinal symptoms, particularly in the first 3-4 weeks: 2
- Diarrhea (most common)
- Nausea
- Headache
- Decreased appetite
- Back pain
- Flu-like symptoms
- Dizziness
These side effects led to increased study withdrawals, particularly early in treatment. 2 Patients should be counseled that these symptoms often improve with continued use but warrant provider contact if severe or persistent.
Dosing Instructions
Standard dosing: 500 mcg once daily, with or without food 1
Alternative initiation strategy (may improve tolerability): 1
- Start with 250 mcg once daily for 4 weeks
- Then increase to 500 mcg once daily
- This approach reduced discontinuation rates by 6.2% in clinical trials (from 24.6% to 18.4%)
- However, long-term tolerability benefit beyond 12 weeks is not established
Critical Drug Interactions
Avoid strong CYP450 enzyme inducers, as they significantly reduce roflumilast effectiveness: 1
- Rifampicin (rifampin)
- Phenobarbital
- Carbamazepine
- Phenytoin
These medications can reduce roflumilast exposure and therapeutic effectiveness. Alternative therapies should be considered when possible.
Storage and Handling
Store at room temperature: 20°-25°C (68°-77°F), with excursions permitted to 15°-30°C (59°-86°F) 1
Contraindications
Do not use in patients with moderate to severe liver impairment. 1 Patients with liver problems should discuss this with their provider before starting therapy.
Pregnancy and Breastfeeding
- Unknown if harmful to unborn baby—discuss with provider if pregnant or planning pregnancy
- Unknown if passes into breast milk—patients should not both breastfeed and take Daliresp 1
Expected Benefits
Realistic expectations should be set: 2
- Modest improvement in lung function (average 39-80 mL increase in FEV₁)
- Reduction in exacerbation rate (17% reduction in pooled analyses)
- Benefits greatest in patients with severe COPD, chronic bronchitis, and history of hospitalizations for exacerbations
- This is an add-on therapy to existing bronchodilators, not a replacement
Follow-up Requirements
Regular monitoring is essential:
- Weight checks at every visit, especially in first 3 months
- Mental health screening at each visit
- Assessment of medication adherence and side effect tolerance
- Evaluation of exacerbation frequency to determine ongoing benefit