What is the recommended dosage and treatment regimen for WIXELA (fluticasone/vilanterol) in patients with asthma or Chronic Obstructive Pulmonary Disease (COPD)?

From the Guidelines

WIXELA (fluticasone/vilanterol) should be prescribed at a dosage of one inhalation once daily for both asthma and COPD patients, with the specific dose depending on prior therapy and severity, as it has been shown to improve lung function, reduce exacerbations, and improve health status 1. The recommended dosage and treatment regimen for WIXELA (fluticasone/vilanterol) in patients with asthma or Chronic Obstructive Pulmonary Disease (COPD) is based on the patient's prior therapy and severity of the disease.

• For asthma, the recommended starting dose depends on prior asthma therapy and severity, with options of 100/25 mcg, 200/25 mcg, or other available doses of fluticasone/vilanterol per inhalation.
• For COPD, the standard dose is typically 100/25 mcg once daily. Some key points to consider when prescribing WIXELA include:
• Patients should rinse their mouth with water without swallowing after each use to reduce the risk of oral thrush.
• It's essential to use WIXELA regularly as prescribed, even when symptoms improve, and not to exceed the recommended dosage.
• This medication works through two mechanisms: fluticasone, an anti-inflammatory corticosteroid that reduces airway inflammation, and vilanterol, a long-acting beta-agonist that relaxes airway muscles.
• Patients should be aware that WIXELA is not a rescue inhaler and should have a short-acting bronchodilator available for acute symptoms.
• Improvement may be noticed within a short period, but optimal benefits typically develop over time with regular use, as supported by guidelines such as those from the American College of Chest Physicians and Canadian Thoracic Society 1 and the European Respiratory Society/American Thoracic Society 1.

From the FDA Drug Label

2.1 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. 2.2 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

The recommended dosage and treatment regimen for WIXELA (fluticasone/vilanterol) in patients with asthma or Chronic Obstructive Pulmonary Disease (COPD) is:

• For COPD: 1 actuation of WIXELA 100/25 mcg once daily by oral inhalation.
• For asthma:
  • Adult patients aged 18 years and older: 1 actuation of WIXELA 100/25 mcg or 200/25 mcg once daily by oral inhalation.
  • Pediatric patients aged 12 to 17 years: 1 actuation of WIXELA 100/25 mcg once daily by oral inhalation.
  • Pediatric patients aged 5 to 11 years: 1 actuation of WIXELA 50/25 mcg once daily by oral inhalation. It is essential to use WIXELA at the same time every day and not more than 1 time every 24 hours 2.

From the Research

Recommended Dosage and Treatment Regimen for WIXELA

The recommended dosage and treatment regimen for WIXELA (fluticasone/vilanterol) in patients with asthma or Chronic Obstructive Pulmonary Disease (COPD) is as follows:

• For asthma, the recommended dosage is 100/50 mcg or 250/50 mcg, administered twice daily 3
• For COPD, the recommended dosage is 250/50 mcg, administered twice daily 3
• The treatment regimen should be individualized and based on the severity of the disease and the patient's response to treatment 4, 5, 6

Bioequivalence and Efficacy

WIXELA has been shown to be bioequivalent to Advair Diskus in terms of efficacy and safety 4, 6, 3

• The bioequivalence of WIXELA to Advair Diskus has been demonstrated in clinical trials, with similar improvements in forced expiratory volume in 1 second (FEV1) and similar incidence of adverse events 4, 6
• WIXELA has also been shown to be effective in reducing the incidence of moderate or severe COPD exacerbations and pneumonia hospitalizations, with similar outcomes to Advair Diskus 7

Dosing Performance and Inhalation Profiles

The dosing performance of WIXELA has been evaluated in vitro and in vivo, with results showing low flow dependency and consistent dose delivery across a range of patient inhalation profiles 5, 6

• The in vitro performance of WIXELA has been compared to Advair Diskus, with similar results in terms of emitted dose and fine particle mass 5, 6
• The inhalation profiles of patients with asthma or COPD have been evaluated, with results showing that WIXELA can be used effectively by patients with a range of inhalation capabilities 6