May 4, 2016
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Breo Ellipta

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Breo Ellipta




Breo Ellipta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/19/2015

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. Breo Ellipta is also used to reduce exacerbations (sudden worsening) of COPD in patients with a history of exacerbations. Common side effects of Breo Ellipta include upper respiratory tract infection, runny nose, sore throat, headache, and oral candidiasis (thrush in your mouth or throat).

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
(Adverse Reactions)

SIDE EFFECTS

LABA, such as vilanterol, one of the active ingredients in BREO ELLIPTA, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. [See WARNINGS AND PRECAUTIONS]

Systemic and local corticosteroid use may result in the following:

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.

Clinical Trials Experience In Chronic Obstructive Pulmonary Disease

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 with COPD received at least 1 dose of BREO ELLIPTA 100/25, and 1,087 subjects received a higher strength of fluticasone furoate/vilanterol. The safety data described below are based on the confirmatory 6-and 12-month trials. Adverse reactions observed in the other trials were similar to those observed in the confirmatory trials.

6-Month Trials

The incidence of adverse reactions associated with BREO ELLIPTA 100/25 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 white. 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 100/25, BREO ELLIPTA 200/25, fluticasone furoate/vilanterol 50 mcg/25 mcg, fluticasone furoate 100 mcg, fluticasone furoate 200 mcg, vilanterol 25 mcg, or placebo.

Table 1: Adverse Reactions with BREO ELLIPTA 100/25 with ≥ 3% Incidence and More Common than Placebo in Subjects with Chronic Obstructive Pulmonary Disease

Adverse Reaction BREO ELLIPTA 100/25
(n = 410) %
Vilanterol 25 mcg
(n = 408) %
Fluticasone Furoate 100 mcg
(n = 410) %
Placebo
(n = 412) %
Infections and infestations
  Nasopharyngitis 9 10 8 8
  Upper respiratory tract infection 7 5 4 3
  Oropharyngeal candidiasisa 5 2 3 2
Nervous system disorders
  Headache 7 9 7 5
aIncludes oral candidiasis, oropharyngeal candidiasis, candidiasis, and fungal oropharyngitis.

12-Month Trials

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 white. 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 100/25, BREO ELLIPTA 200/25, fluticasone furoate/vilanterol 50 mcg/25 mcg, or vilanterol 25 mcg. In addition to the reactions shown in Table 1, adverse reactions occurring in greater than or equal to 3% of the subjects treated with BREO ELLIPTA 100/25 (n = 806) for 12 months included back pain, pneumonia [see WARNINGS AND PRECAUTIONS], bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, influenza, pharyngitis, and pyrexia.

Clinical Trials Experience In Asthma

BREO ELLIPTA for the treatment of asthma was studied in 18 double-blind, parallel-group, controlled trials (11 with placebo) of 4 to 76 weeks' duration, which enrolled 9,969 subjects with asthma. BREO ELLIPTA 100/25 was studied in 2,369 subjects and BREO ELLIPTA 200/25 was studied in 956 subjects. While subjects aged 12 to 17 years were included in these trials, BREO ELLIPTA is not approved for use in this age-group [see Use in Specific Populations]. The safety data described below are based on two 12-week efficacy trials, one 24-week efficacy trial, and two long-term trials.

12-Week Trials

Trial 1 was a 12-week trial that evaluated the efficacy of BREO ELLIPTA 100/25 in adolescent and adult subjects with asthma compared with fluticasone furoate 100 mcg and placebo. Of the 609 subjects, 58% were female and 84% were white; the mean age was 40 years. The incidence of adverse reactions associated with BREO ELLIPTA 100/25 is shown in Table 2.

Table 2: Adverse Reactions with BREO ELLIPTA 100/25 with ≥ 2% Incidence and More Common than Placebo in Subjects with Asthma (Trial 1)

Adverse Reaction BREO ELLIPTA 100/25
(n = 201) %
Fluticasone Furoate 100 mcg
(n = 205) %
Placebo
(n = 203) %
Infections and infestations
  Nasopharyngitis 10 7 7
  Oral candidiasisa 2 2 0
Nervous system disorders
  Headache 5 4 4
Respiratory, thoracic, and mediastinal disorders
  Oropharyngeal pain  2 2 1
  Dysphonia 2 1 0
aIncludes oral candidiasis and oropharyngeal candidiasis.

Trial 2 was a 12-week trial that evaluated the efficacy of BREO ELLIPTA 100/25, BREO ELLIPTA 200/25, and fluticasone furoate 100 mcg in adolescent and adult subjects with asthma. This trial did not have a placebo arm. Of the 1,039 subjects, 60% were female and 88% were white; the mean age was 46 years. The incidence of adverse reactions associated with BREO ELLIPTA 100/25 and BREO ELLIPTA 200/25 is shown in Table 3.

Table 3: Adverse Reactions with BREO ELLIPTA 100/25 and BREO ELLIPTA 200/25 with ≥ 2% Incidence in Subjects with Asthma (Trial 2)

Adverse Reaction BREO ELLIPTA 200/25
(n = 346) %
BREO ELLIPTA 100/25
(n = 346) %
Fluticasone Furoate 100 mcg
(n = 347) %
Nervous system disorders
  Headache 8 8 9
Infections and infestations 
  Nasopharyngitis 7 6 7
  Influenza 3 3 1
  Upper respiratory tract infection 2 2 3
  Sinusitis  2 1 < 1
  Bronchitis 2 < 1 2
Respiratory, thoracic and mediastinal disorders
  Oropharyngeal pain 2 2 1
  Cough 1 2 1

24-Week Trial

Trial 3 was a 24-week trial that evaluated the efficacy of BREO ELLIPTA 200/25 once daily, fluticasone furoate 200 mcg once daily, and fluticasone propionate 500 mcg twice daily in adolescent and adult subjects with asthma. Of the 586 subjects, 59% were female and 84% were white; the mean age was 46 years. This trial did not have a placebo arm. In addition to the reactions shown in Tables 2 and 3, adverse reactions occurring in greater than or equal to 2% of subjects treated with BREO ELLIPTA 200/25 included viral respiratory tract infection, pharyngitis, pyrexia, and arthralgia.

12-Month Trial

Long-term safety data is based on a 12-month trial that evaluated the safety of BREO ELLIPTA 100/25 once daily (n = 201), BREO ELLIPTA 200/25 once daily (n = 202), and fluticasone propionate 500 mcg twice daily (n = 100) in adolescent and adult subjects with asthma (Trial 4). Overall, 63% were female and 67% were white. The mean age was 39 years; adolescents (aged 12 to 17 years) made up 16% of the population. In addition to the reactions shown in Tables 2 and 3, adverse reactions occurring in greater than or equal to 2% of the subjects treated with BREO ELLIPTA 100/25 or BREO ELLIPTA 200/25 for 12 months included pyrexia, back pain, extrasystoles, upper abdominal pain, respiratory tract infection, allergic rhinitis, pharyngitis, rhinitis, arthralgia, supraventricular extrasystoles, ventricular extrasystoles, acute sinusitis, and pneumonia.

Exacerbation Trial

In a 24-to 76-week trial, subjects received BREO ELLIPTA 100/25 (n = 1,009) or fluticasone furoate 100 mcg (n = 1,010) (Trial 5). Subjects participating in this trial had a history of one or more asthma exacerbations that required treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization for the treatment of asthma in the year prior to trial entry. Overall, 67% were female and 73% were white; the mean age was 42 years (adolescents aged 12 to 17 years made up 14% of the population). While subjects aged 12 to 17 years were included in this trial, BREO ELLIPTA is not approved for use in this age-group [see Use in Specific Populations]. Asthma-related hospitalizations occurred in 10 subjects (1%) treated with BREO ELLIPTA 100/25 compared with 7 subjects (0.7%) treated with fluticasone furoate 100 mcg. Among subjects aged 12 to 17 years, asthma-related hospitalizations occurred in 4 subjects (2.6%) treated with BREO ELLIPTA 100/25 (n = 151) compared with 0 subjects treated with fluticasone furoate 100 mcg (n = 130). There were no asthma-related deaths or asthma-related intubations observed in this trial.

Postmarketing Experience

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.

Cardiac Disorders

Palpitations, tachycardia.

Immune System Disorders

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.

Musculoskeletal and Connective Tissue Disorders

Muscle spasms.

Nervous System Disorders

Tremor.

Psychiatric Disorders

Nervousness.

Read the entire FDA prescribing information for Breo Ellipta (Fluticasone Furoate and Vilanterol Inhalation Powder)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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