Recommended Dosage for Maintenance Treatment of Chronic Obstructive Pulmonary Disease

The recommended dosage of BREO ELLIPTA 100/25 mcg (containing fluticasone furoate 100 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation.

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be used for immediate relief.

Recommended Dosage for Maintenance Treatment of Asthma

​Adult Patients Aged 18 Years and Older

​The recommended dosage of BREO ELLIPTA 100/25 mcg (containing fluticasone furoate 100 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation or BREO ELLIPTA 200/25 mcg (containing fluticasone furoate 200 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation.

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​When choosing the starting dosage strength of BREO ELLIPTA, consider the patients’ disease severity, their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage, as well as the patients’ current control of asthma symptoms and risk of future exacerbation.

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​The median time to onset, defined as a 100-mL increase from baseline in mean forced expiratory volume in 1 second (FEV1), was approximately 15 minutes after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

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​For patients who do not respond adequately to BREO ELLIPTA 100/25 mcg once daily, increasing the dose to BREO ELLIPTA 200/25 mcg once daily may provide additional improvement in asthma control. For patients who do not respond adequately to BREO ELLIPTA 200/25 mcg once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options.

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​The maximum recommended dosage is 1 inhalation of BREO ELLIPTA 200/25 mcg once daily.

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​If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be used for immediate relief.

​Pediatric Patients Aged 12 to 17 Years

​The recommended dosage of BREO ELLIPTA 100/25 mcg (containing fluticasone furoate 100 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation [see Warnings and Precautions (5.14​)]​.

​Pediatric Patients Aged 5 to 11 Years

​The recommended dosage of BREO ELLIPTA 50/25 mcg (containing fluticasone furoate 50 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation [see Warnings and Precautions (5.14​)]​.

Administration Information

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After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis [see Warnings and Precautions (5.4)].

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BREO ELLIPTA should be used at the same time every day. Do not use BREO ELLIPTA more than 1 time every 24 hours.

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More frequent administration or a greater number of inhalations (more than 1 inhalation daily) of the prescribed strength of BREO ELLIPTA is not recommended as some patients are more likely to experience adverse effects with higher doses.