"The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary di"...
Breo Ellipta Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Breo Ellipta (fluticasone furoate and vilanterol) is a combination inhaled corticosteroid (ICS) and long-acting beta2-adrenergic agonists (LABA) used to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also used to reduce exacerbations (sudden worsening) of COPD in patients with a history of exacerbations. Common side effects from use of Breo Ellipta are upper respiratory tract infection, headache, and oral candidiasis (thrush).
Breo Ellipta is dosed as 100 mcg/25 mcg once daily. Breo Ellipta is a dry powder for oral inhalation only. Patients with allergies to milk or milk proteins and patients with sensitivities to any component of Breo Ellipta should not use it. Breo Ellipta may interact with antifungal medications containing ketoconazole, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, beta-blockers, or diuretics. Breo Ellipta should only be used in pregnant women if the potential benefit justifies the potential risk to the fetus. Contact your physician if you become pregnant while taking Breo Ellipta. It is not known if Breo Ellipta is excreted in human breast milk. Consult your doctor before breastfeeding.
Breo Ellipta (fluticasone furoate and vilanterol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Breo Ellipta FDA Prescribing Information: Side Effects
LABA, such as vilanterol, one of the active ingredients in BREO ELLIPTA, increase the risk of asthma-related death. BREO ELLIPTA is not indicated for the treatment of asthma. [See BOXED WARNINGS and WARNINGS AND PRECAUTIONS]
Systemic and local corticosteroid use may result in the following:
- Increased risk of pneumonia in COPD [see WARNINGS AND PRECAUTIONS]
- Increased risk for decrease in bone mineral density [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical program for BREO ELLIPTA included 7,700 subjects with COPD in two 6-month lung function trials, two 12-month exacerbation trials, and 6 other trials of shorter duration. A total of 2,034 subjects have received at least 1 dose of BREO ELLIPTA 100 mcg/25 mcg, and 1,087 subjects have received higher doses of fluticasone furoate/vilanterol. The safety data described below are based on the confirmatory 6-month and 12-month trials. Adverse reactions observed in the other trials were similar to those observed in the confirmatory trials.
The incidence of adverse reactions associated with BREO ELLIPTA in Table 1 is based on 2 placebo-controlled, 6-month clinical trials (Trials 1 and 2; n = 1,224 and n = 1,030, respectively). Of the 2,254 subjects, 70% were male and 84% were Caucasian. They had a mean age of 62 years and an average smoking history of 44 pack years, with 54% identified as current smokers. At screening, the mean postbronchodilator percent predicted FEV1 was 48% (range: 14% to 87%), the mean postbronchodilator FEV1/forced vital capacity (FVC) ratio was 47% (range: 17% to 88%), and the mean percent reversibility was 14% (range: -41% to 152%).
Subjects received 1 inhalation once daily of the following: BREO ELLIPTA 100 mcg/25 mcg, fluticasone furoate/vilanterol 50 mcg/25 mcg, fluticasone furoate/vilanterol 200 mcg/25 mcg, fluticasone furoate 100 mcg, fluticasone furoate 200 mcg, vilanterol 25 mcg, or placebo.
Table 1: Adverse Reactions With ≥ 3% Incidence
and More Common Than Placebo With BREO ELLIPTA in Subjects With Chronic
Obstructive Pu monary Disease
|Adverse Event||BREO ELLIPTA 100 mcg/25 mcg
(n = 410) %
|Vilanterol 25 mcg
(n = 408) %
|Fluticasone Furoate 100 mcg
(n = 410) %
(n = 412) %
|Infections and infestations|
|Upper respiratory tract infection||7||5||4||3|
|Nervous system disorders|
|a Includes terms oral candidiasis, oropharyngeal candidiasis, candidiasis, and oropharyngitis fungal.|
Long-term safety data is based on two 12-month trials (Trials 3 and 4; n = 1,633 and n = 1,622, respectively). Trials 3 and 4 included 3,255 subjects, of which 57% were male and 85% were Caucasian. They had a mean age of 64 years and an average smoking history of 46 pack years, with 44% identified as current smokers. At screening, the mean postbronchodilator percent predicted FEV1 was 45% (range: 12% to 91%), and the mean postbronchodilator FEV1/FVC ratio was 46% (range: 17% to 81%), indicating that the subject population had moderate to very severely impaired airflow obstruction. Subjects received 1 inhalation once daily of the following: BREO ELLIPTA 100 mcg/25 mcg, fluticasone furoate/vilanterol 50 mcg/25 mcg, fluticasone furoate/vilanterol 200 mcg/25 mcg, or vilanterol 25 mcg. In addition to the events shown in Table 1, adverse reactions occurring in greater than or equal to 3% of the subjects treated with BREO ELLIPTA (N = 806) for 12 months included COPD, back pain, pneumonia [see WARNINGS AND PRECAUTIONS], bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia.
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of BREO ELLIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to BREO ELLIPTA or a combination of these factors.
Immune System Disorders
Read the entire FDA prescribing information for Breo Ellipta (Fluticasone Furoate and Vilanterol Inhalation Powder)
Additional Breo Ellipta Information
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