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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
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INDICATIONS AND USAGE
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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)
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DOSAGE AND ADMINISTRATION
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The recommended dosage for patients with COPD is one 500 mcgtablet per day, with or without food. (2)
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DOSAGE FORMS AND STRENGTHS
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Tablets: 500 mcg (3)
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CONTRAINDICATIONS
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Moderate to severe liver impairment (Child-Pugh B or C) (4)
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WARNINGS AND PRECAUTIONS
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Acute bronchospasm: Do not use for the relief of acute bronchospasm. (5.1)
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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)
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Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, eva luate weight loss and consider discontinuation of DALIRESP. (5.3)
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Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended. (5.4)
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ADVERSE REACTIONS
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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.
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DRUG INTERACTIONS
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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)
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USE IN SPECIFIC POPULATIONS
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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)
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See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide |
Revised: 02/2011 |
Back to Highlights and Tabs
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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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
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:
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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, and families should be advised of the need 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. Prescribers should carefully eva luate the risks and benefits of continuing treatment with DALIRESP if such events occur.
5.3 Weight Decrease
Weight loss was a common adverse reaction in DALIRESP clinical trials and was reported in 7.5% (331) of patients treated with DALIRESP 500 mcg once daily compared to 2.1% (89) treated with placebo [see Adverse Reactions (6.1)]. In addition to being reported as adverse reactions, weight was prospectively assessed in two placebo-controlled clinical trials of one year duration. In these studies, 20% of patients receiving roflumilast experienced moderate weight loss (defined as between 5-10% of body weight) compared to 7% of patients who received placebo. In addition, 7% of patients who received roflumilast compared to 2% of patients receiving placebo experienced severe (>10% body weight) weight loss. During follow-up after treatment discontinuation, the majority of patients with weight loss regained some of the weight they had lost while receiving DALIRESP. Patients treated with DALIRESP sh
