Reducing the Risk of Exacerbations
In clinical studies, DALIRESP significantly reduced the rate of moderate or severe exacerbations vs placebo in the indicated population.
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DALIRESP Patients
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For patients with severe COPD associated with chronic bronchitis and a history of exacerbations

DALIRESP offers once-daily oral dosing

The recommended dose of DALIRESP is one 500 mcg tablet once per day, with or without food.1

Also, there is no dosage adjustment necessary for adults based on age, gender, or race,
or those with renal impairment1

  • DALIRESP should not be used during pregnancy, labor and delivery, or by nursing mothers because excretion of
    roflumilast and/or its metabolites into human milk is probable
  • Greater sensitivity of some older individuals cannot be ruled out

DALIRESP is contraindicated in patients with moderate to severe liver impairment
(Child-Pugh B or C)1

  • Clinicians should consider the risk-benefit of administering DALIRESP to patients with mild liver impairment
    (Child-Pugh A)
dosing image

“Appropriate treatment and measures to prevent further exacerbations should be implemented as quickly as possible.”

– 2010 GOLD Guidelines

For patient-related materials, visit Patient Types Overview

Indications and Usage

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

Important Safety Information
Contraindications

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

Warnings and Precautions
  • DALIRESP is not a bronchodilator and should not be used for the relief of acute bronchospasm.
  • Prescribers should 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. Prescribers should carefully evaluate the risks and benefits of continuing treatment if such events occur. 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.
    • Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions. In controlled clinical trials 5.9% of patients treated with DALIRESP reported psychiatric adverse reactions vs 3.3% treated with placebo. The most common psychiatric adverse reactions were insomnia (2.4% vs 1.0%), anxiety (1.4% vs 0.9%), and depression (1.2% vs 0.9%). Three patients treated with DALIRESP experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) compared to one patient (suicidal ideation) treated with placebo.
  • Patients should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated and treatment discontinuation considered.
    • In addition to weight loss being reported as a common adverse reaction (7.5% of patients treated with DALIRESP vs 2.1% placebo), weight was prospectively assessed in two 1-year clinical trials. In these studies that compared DALIRESP to placebo, 20% vs 7% experienced moderate weight loss (5-10% of body weight) and 7% vs 2% experienced severe weight loss (>10% body weight). During the follow-up period after discontinuing DALIRESP, the majority of patients regained some of the weight they had lost.
  • Use with strong cytochrome P450 enzyme inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended, as they decrease the exposure and may reduce the therapeutic effectiveness of DALIRESP.
Adverse Reactions

In clinical trials the most common adverse reactions (≥2% and greater than placebo) were diarrhea (9.5% vs 2.7%), weight loss (7.5% vs 2.1%), nausea (4.7% vs 1.4%), headache (4.4% vs 2.1%), back pain (3.2% vs 2.2%), influenza (2.8% vs 2.7%), insomnia (2.4% vs 1.0%), dizziness (2.1% vs 1.1%), and decreased appetite (2.1% vs 0.4%).

Please see full Prescribing Information.

References:
  1. DALIRESP (roflumilast) Prescribing Information. Forest Pharmaceuticals, Inc. St. Louis, MO.
  2. US Food and Drug Administration. FDA news release. March 1, 2011. http://www.fda.gov/NewsEvents/newsroom/PressAnnouncements/ucm244989.htm. Accessed April 11, 2013.
  3. Data on file. Forest Laboratories, Inc.
  4. Calverley PMA, Rabe KF, Goehring U-M, Kristiansen S, Fabbri LM, Martinez FJ; for the M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009;374:685-694.
  5. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2013. http://www.goldcopd.org/uploads/users/files/GOLD_Report_2013_Feb20.pdf. Accessed April 11, 2013.
  6. US Food and Drug Administration. Atrovent approval history (NDA 019085, 1986). Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed July 16, 2012.
  7. Burge S, Wedzicha JA. COPD exacerbations: definitions and classifications. Eur Respir J. 2003;(Suppl. 41);46s-53s.
  8. Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000;117:398S-401S.
  9. Foreman MG, DeMeo DL, Hersh CP, Reilly JJ, Silverman EK. Clinical determinants of exacerbations in severe, early-onset COPD. Eur Respir J. 2007;30:1124-1130.
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