ADVAIR DISKUS

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma ADVAIR DISKUS is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. ADVAIR DISKUS should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated. Important Limitation of Use ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm. Dosage and administration 2 DOSAGE AND ADMINISTRATION ADVAIR DISKUS should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of ADVAIR DISKUS is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using ADVAIR DISKUS should not use additional LABA for any reason. [See Warnings and Precautions ( 5.3 , 5.12 ).] • For oral inhalation only. ( 2 ) • Treatment of asthma in patients aged 12 years and older: 1 inhalation of ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, or ADVAIR DISKUS 500/50 twice daily. Starting dosage is based on asthma severity. ( 2.1 ) • Treatment of asthma in patients aged 4 to 11 years: 1 inhalation of ADVAIR DISKUS 100/50 twice daily. ( 2.1 ) • Maintenance treatment of COPD: 1 inhalation of ADVAIR DISKUS 250/50 twice daily. ( 2.2 ) 2.1 Asthma If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. Adult and Adolescent Patients Aged 12 Years and Older For patients aged 12 years and older, the dosage is 1 inhalation twice daily, approximately 12 hours apart. When choosing the starting dosage strength of ADVAIR DISKUS, consider the patients’ disease severity, based on their previous asthma therapy, including the ICS dosage, as well as the patients’ current control of asthma symptoms and risk of future exacerbation. The maximum recommended dosage is ADVAIR DISKUS 500/50 twice daily. Improvement in asthma control following inhaled administration of ADVAIR DISKUS can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of ADVAIR DISKUS with a higher strength may provide additional improvement in asthma control. If a previously effective dosage regimen fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the current strength of ADVAIR DISKUS with a higher strength, adding additional ICS, initiating oral corticosteroids) should be considered. Pediatric Patients Aged 4 to 11 Years For patients with asthma aged 4 to 11 years who are not controlled on an ICS, the dosage is 1 inhalation of ADVAIR DISKUS 100/50 twice daily, approximately 12 hours apart. 2.2 Chronic Obstructive Pulmonary Disease The recommended dosage for patients with COPD is 1 inhalation of ADVAIR DISKUS 250/50 twice daily, approximately 12 hours apart. If shortness of breath occurs in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. Warnings and cautions 5 WARNINGS AND PRECAUTIONS • LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 ) • Do not initiate in acutely deterio