Fluticasone furoate and vilanterol: Combination drug for COPD

Fluticasone furoate and vilanterol inhalation powder (Breo Ellipta—GlaxoSmithKline, Theravance)

Fluticasone furoate and vilanterol inhalation powder (Breo Ellipta—GlaxoSmithKline, Theravance) has received FDA approval as the first long-term, once-daily drug for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The product combines fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta-2 adrenergic agonist (LABA). Together these drugs decrease lung inflammation and help the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.

Efficacy and safety data

The drug’s safety and efficacy were evaluated in 7,700 patients with a clinical diagnosis of COPD in two placebo-controlled 6-month trials of lung function, two 1-year exacerbation trials, and six other trials of shorter duration. Patients using the fluticasone furoate/vilanterol combination showed improved lung function and reduced exacerbations compared with those using a placebo.

The most common adverse reactions reported in the 6-month clinical trials were runny nose, sore throat, upper respiratory tract infection, headache, and oral candidiasis. Adverse reactions occurring in the 1-year studies included the above events as well as back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia. Some pneumonias resulted in hospitalization and fatalities.

The drug carries a boxed warning that LABAs increase the risk of asthma-related death. Its safety and efficacy in patients with asthma have not been established; it is not approved for the treatment of asthma. It is not recommended for patients younger than 18 years.

Contraindications and precautions

Patients with hypersensitivity to milk proteins or to fluticasone furoate, vilanterol, or the inactive ingredients should not use the product. Rapidly deteriorating or potentially life-threatening COPD episodes or acute bronchospasm should be treated with a rescue inhaler such as albuterol.

Corticosteroids such as fluticasone furoate may worsen existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex, and a more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Particular care is needed for patients with asthma who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred. Hypercorticism and adrenal suppression may result from very high dosages or at the regular dosage of inhaled corticosteroids in some patients.

The product will be available in the United States during the third quarter of 2013, according to GlaxoSmithKline.

Fluticasone furoate and vilanterol inhalation powder (Breo Ellipta)

Manufacturer: GlaxoSmithKline, Theravance

Drug class: Corticosteroid and LABA

Indication: Maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD

Dosage: One inhalation of 100 µg/25 µg once daily at the same time every day

  • The disposable inhaler contains two double-foil strips of 30 blisters each. One strip contains fluticasone furoate 100 µg per blister and the other contains vilanterol 25 µg per blister.
  • After inhalation, patients should rinse their mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

Of note: The product has a boxed warning about the risk of asthma-related death. A placebo-controlled trial with another LABA, salmeterol, showed an increase in these deaths. This finding is considered a class effect of all LABAs, including vilanterol.
Other warnings and precautions include increased risk of pneumonia, potential worsening of infections, risk of impaired adrenal function when transferring from systemic corticosteroids, and paradoxical bronchospasm. Patients with severe allergy to milk protein should not use the product because anaphylactic reactions may occur.

Patient counseling

Give patients the Medication Guide and instruct them to read it. Inform patients of potential adverse effects, including the risk of asthma-related death from the use of LABAs such as vilanterol. Instruct patients to notify their physician immediately if symptoms worsen, they need more inhalations than usual of their rescue inhaler, or they experience a significant decrease in lung function as outlined by their physician.