HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DALIRESP safely and effectively. See full prescribing information for DALIRESP.
DALIRESP™ (roflumilast) tablets
Initial U.S. Approval: 2011
INDICATIONS AND USAGE
DALIRESP 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. (1, 14)
Limitations of Use: DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm. (1, 14)
DOSAGE AND ADMINISTRATION
The recommended dosage for patients with COPD is one 500 mcgtablet per day, with or without food. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mcg (3)
CONTRAINDICATIONS
Moderate to severe liver impairment (Child-Pugh B or C) (4)
WARNINGS AND PRECAUTIONS
Acute bronchospasm: Do not use for the relief of acute bronchospasm. (5.1)
Psychiatric Events including Suicidality: Advise patients , their caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully weigh the risks and benefits of treatment with DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior. (5.2)
Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, eva luate weight loss and consider discontinuation of DALIRESP. (5.3)
Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (≥ 2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite. (6.1)
To report SUSPECTED ADVERSE REACTIONS, Contact Forest Laboratories, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Use with inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 (e.g, erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) will increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit. (7.2)
USE IN SPECIFIC POPULATIONS
Nursing Mothers: DALIRESP should not be used by women who are nursing as excretion of roflumilast and/or its metabolites into human milk is probable and there are no human studies that have investigated effects of DALIRESP on breast-fed infants. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide
Revised: 02/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Treatment of Acute Bronchospasm
5.2 Psychiatric Events including Suicidality
5.3 Weight Decrease
5.4 Drug Interactions
