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. 

DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

DALIRESP is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions. Instances of suicidal ideation and behavior, including completed suicide, have been observed in clinical trials. Before using DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with DALIRESP in such patients.

Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions. The most commonly reported psychiatric adverse reactions were insomnia, anxiety, and depression.

Weight loss was a common adverse reaction in DALIRESP clinical trials. Patients treated with DALIRESP should have their weight monitored regularly.

Use with strong cytochrome P450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended.

Co-administration of DALIRESP (500 mcg) with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast systemic exposure and may result in increased adverse reactions.

Co-administration of DALIRESP (500 mcg) with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.

There are no randomized clinical studies of DALIRESP in pregnant women. DALIRESP should not be used during labor and delivery.

DALIRESP should not be used by women who are nursing.

GoToSource

• Dosage greater than one 500 mcg tablet per day. GoToSource

• Use in patients under the age of 18. GoToSource

• Asthma and cystic fibrosis. GoToSource

• Emphysema and pulmonary hypertension. GoToSource

• Acute bronchospasm. GoToSource 

• Psoriasis, psoriatic arthritis, granulomatous skin diseases, chronic eczema and cutaneous lupus erythematosus. GoToSource

• Diabetes. GoToSource

• Inflammatory bowel disease. GoToSource

• Myeloid and lymphoid malignancies, multiple sclerosis, infection-induced preterm labor and alzheimer’s disease. GoToSource

Psychiatric disorders including insomnia, anxiety, nervousness, depression and suicidal ideation and behavior. GoToSource

Mesenteric vasculitis (arterial disease). GoToSource

Intractable diarrhea and severe weight loss. GoToSource

Atrial fibrillation. GoToSource

Prostate, lung, colorectal cancers and pancreatitis. GoToSource

Lawsuits filed for suicide and cancer.