Breo Ellipta

Last updated on RxList: 8/27/2020
Breo Ellipta Side Effects Center

What Is Breo Ellipta?

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.

What Are Side Effects of Breo Ellipta?

Common side effects of Breo Ellipta include:

Dosage for Breo Ellipta

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.

What Drugs, Substances, or Supplements Interact with Breo Ellipta?

Breo Ellipta may interact with antifungal medications containing ketoconazole, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, beta-blockers, or diuretics.

Breo Ellipta During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Breo Ellipta Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • chest pain, fast or pounding heartbeats, pounding in your neck or ears;
  • sores or white patches in your mouth and throat, pain when swallowing;
  • fever, chills, cough with yellow or green mucus;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights.
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
  • signs of a hormonal disorder--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Common side effects may include:

  • headache, back pain, joint pain;
  • fever, flu symptoms;
  • increased blood pressure;
  • runny or stuffy nose, sore throat, cough; or
  • a hoarse voice.

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.

Read the entire detailed patient monograph for Breo Ellipta (Fluticasone Furoate and Vilanterol Inhalation Powder)

SLIDESHOW

COPD Foods to Boost Your Health - COPD Diet Tips See Slideshow
Breo Ellipta Professional Information

SIDE EFFECTS

Use of LABA may result in the following:

  • Serious asthma-related events – hospitalizations, intubations, death [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular effects [see WARNINGS AND PRECAUTIONS]

Systemic and local corticosteroid use may result in the following:

  • Candida albicans infection [see WARNINGS AND PRECAUTIONS]
  • Increased risk of pneumonia in COPD [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
  • Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]

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 more than 24,000 subjects with COPD in two 6-month lung function trials, two 12-month exacerbation trials, 1 mortality trial, and 6 other trials of shorter duration. A total of 6,174 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 2 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 2. 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
a Includes oral candidiasis, oropharyngeal candidiasis, candidiasis, and fungal oropharyngitis.

12-Month Trials

Long-term safety data are 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 2 ,adverse reactions occurring in ≥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.

Mortality Trial

Safety data are available from a mortality trial in subjects with moderate COPD (moderate airflow limitation [≥50% and ≤70% predicted FEV1]) who either had a history of, or were at risk of, cardiovascular disease and were treated for up to 4 years (median treatment duration of 1.5 years). The trial included 16,568 subjects, 4,140 of whom received BREO ELLIPTA 100/25. In addition to the events in COPD trials shown in Table 2, adverse reactions occurring in ≥3% of the subjects treated with BREO ELLIPTA 100/25 and more common than placebo included pneumonia, back pain, hypertension, and influenza.

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 2 long-term trials.

12-Week Trials

Trial 1 was a 12-week trial that evaluated the efficacy of BREO ELLIPTA 100/25 in adult and adolescent 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 3.

Table 3. 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
a Includes 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 adult and adolescent 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 4.

Table 4. 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 adult and adolescent 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 3 and 4, adverse reactions occurring in ≥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 are 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 adult and adolescent 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 3 and 4, adverse reactions occurring in ≥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 1 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.

Metabolism and Nutrition Disorders

Hyperglycemia.

Musculoskeletal and Connective Tissue Disorders

Muscle spasms.

Nervous System Disorders

Tremor.

Psychiatric Disorders

Nervousness.

Respiratory, Thoracic, and Mediastinal Disorders

Paradoxical bronchospasm.

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

© Breo Ellipta Patient Information is supplied by Cerner Multum, Inc. and Breo Ellipta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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