6 ADVERSE REACTIONS
6.1 Adverse Reactions in Clinical Studies
7 DRUG INTERACTIONS
7.1 Drugs That Induce Cytochrome P450 (CYP) Enzymes
7.2 Drugs That Inhibit Cytochrome P450 (CYP) Enzymes
7.3 Oral Contraceptives Containing Gestodene and Ethinyl Estradiol
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
10.1 Human Experience
10.2 Management of Overdose
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Chronic Obstructive Pulmonary Disease (COPD)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
17.1 Bronchospasm
17.2 Psychiatric Events including Suicidality
17.3 Weight Decrease
17.4 Drug Interactions
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FULL PRESCRIBING INFORMATION
1 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.
Limitations of Use
DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
2 DOSAGE AND ADMINISTRATION
The recommended dose of DALIRESP is one 500 microgram (mcg) tablet per day, with or without food.
3 DOSAGE FORMS AND STRENGTHS
DALIRESP is supplied as white to off-white, round tablets, embossed with “D” on one side and “500” on the other side. Each tablet contains 500 mcg of roflumilast.
4 CONTRAINDICATIONS
The use of DALIRESP is contraindicated in the following conditions:
Moderate to severe liver impairment (Child-Pugh B or C) [see Clinical Pharmacology (12.3) and Use in Special Populations (8.6)].
5 WARNINGS AND PRECAUTIONS
5.1 Treatment of Acute Bronchospasm
DALIRESP is not a bronchodilator and should not be used for the relief of acute bronchospasm.
5.2 Psychiatric Events including Suicidality
Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions. In 8 controlled clinical trials 5.9% (263) of patients treated with DALIRESP 500 mcg daily reported psychiatric adverse reactions compared to 3.3% (137) treated with placebo. The most commonly reported psychiatric adverse reactions were insomnia, anxiety, and depression which were reported at higher rates in those treated with DALIRESP 500 mcg daily (2.4%, 1.4%, and 1.2% for DALIRESP versus 1.0%, 0.9%, and 0.9% for placebo, respectively) [see Adverse Reactions (6.1)]. Instances of suicidal ideation and behavior, including completed suicide, have been observed in clinical trials. Three patients experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) while receiving DALIRESP compared to one patient (suicidal ideation) who received placebo.
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. Patients, their caregivers, an
