"I love Exacerbation Treatment for Severe COPD | DALIRESP®(roflumilast) | For HCPs"

2022-07-13 15:13:39

Exacerbation Treatment for Severe COPD | DALIRESP®(roflumilast) | For HCPs Error 404 Search Results | DALIRESP® (roflumilast) Health Care Professional Site Important Safety Information | DALIRESP® (roflumilast) | For HCPs Contact US | DALIRESP®(roflumilast) | For HCPs DALIRESP® (roflumilast) Dosing | For HCPs DALIRESP®(roflumilast) Efficacy | For HCPs Safety and Adverse Reactions | DALIRESP®(roflumilast) | For HCPs DALIRESP® (roflumilast) Mechanism of Action | For HCPs Sitemap for HCPs | DALIRESP®(roflumilast) | For HCPs print_label | resize_label For US Health Care Professionals Visit Patient Site | AZ Medical Information Support Important Safety Information | Indication | Prescribing Information | Medication Guide MENU CLOSE MENU HOME EFFICACY DOSING SAFETY MECHANISM OF ACTION To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations PATIENT SAVINGS OFFER SEE MORE 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 is not indicated for the relief of acute bronchospasm HELP PREVENT COPD EXACERBATIONS ADD DALIRESP* In the two 1-year placebo-controlled pivotal studies… Without DALIRESP, patients had a 20% higher rate of moderate or severe exacerbations1† *In the two 1-year pivotal studies, patients were allowed to be on long-acting β2 agonist (LABA) or short-acting muscarinic antagonist (SAMA) at stable doses. Short-acting β2 agonist (SABA) was allowed for rescue use. In the pooled analysis, the use of concomitant bronchodilators in the placebo group vs DALIRESP 500-mcg group were LABA (51% vs 49%), SAMA (37% vs 35%), and SABA (99% vs 100%). †Moderate exacerbations were defined as those requiring treatment with systemic corticosteroids, and severe exacerbations were defined as those resulting in hospitalization or death. Study design: A pooled analysis of two identical, 1-year, double-blind, placebo-controlled studies of 3091 patients with severe COPD associated with chronic bronchitis and a history of exacerbations compared DALIRESP 500 mcg and placebo. The studies were designed to assess the rate of moderate or severe COPD exacerbations and the change from baseline in pre-bronchodilator FEV1. RR=rate ratio. *In the two 1-year pivotal studies, patients were allowed to be on long-acting β2 agonist (LABA) or short-acting muscarinic antagonist (SAMA) at stable doses. Short-acting β2 agonist (SABA) was allowed for rescue use. In the pooled analysis, the use of concomitant bronchodilators in the placebo group vs DALIRESP 500-mcg group were LABA (51% vs 49%), SAMA (37% vs 35%), and SABA (99% vs 100%). †Moderate exacerbations were defined as those requiring treatment with systemic corticosteroids, and severe exacerbations were defined as those resulting in hospitalization or death. Study design: A pooled analysis of two identical, 1-year, double-blind, placebo-controlled studies of 3091 patients with severe COPD associated with chronic bronchitis and a history of exacerbations compared DALIRESP 500 mcg and placebo. The studies were designed to assess the rate of moderate or severe COPD exacerbations and the change from baseline in pre-bronchodilator FEV1. RR=rate ratio. NUMBER NEEDED TO TREAT LEARN MORE » VIEW DALIRESP EFFICACY DATA FIND OUT ABOUT DALIRESP DOSING VIEW DALIRESP SAFETY PROFILE HELP YOUR PATIENTS SAVE ON DALIRESP 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 8 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 in these studies 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. In an additional placebo-controlled 1-year clinical trial (Trial 9), which assessed the effect of DALIRESP when added to a fixed-dose combination of an inhaled corticosteroid and long-acting beta agonist, one patient completed suicide while receiving DALIRESP 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 pivotal 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 8 controlled 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%). The safety profile of DALIRESP in Trial 9 was consistent with the key pivotal studies. INDICATION AND USAGE DALIRESP® (roflumilast) is indicated as a treatment to reduce the risk of chronic obstructive pulmonary disease (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 DALIRESP 250 mcg is a starting dose for the first 4 weeks of treatment only and is not the effective (therapeutic) dose Please read full Prescribing Information, including Medication Guide. You may report side effects related to AstraZeneca products by clicking here. References: Data on File, REF-50379, AZPLP. Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 Study Groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009;374:685-694. Contact Us | AstraZeneca US Corporate Site | Privacy Notice | Cookie Notice | Legal Statement | Site Map | Prescribing Information This product information is intended for US Health Care Professionals only. DALIRESP is a registered trademark and AZ&Me is a trademark of the AstraZeneca group of companies. DALIRESP is a registered trademark and AZ&Me is a trademark of the AstraZeneca group of companies. ©2019 AstraZeneca. All rights reserved. US-31742 Last Updated 8/19 YOU ARE LEAVING THIS SITE This link will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to Web site visitors. AstraZeneca is not responsible for the privacy policy of any third-party Web sites. We encourage you to read the privacy policy of every Web site you visit. BACK CONTINUE