From the Guidelines
Wixela Inhub (fluticasone propionate/salmeterol) is recommended at a dosage of 250/50 mcg twice daily for COPD patients, with each dose containing 250 mcg of fluticasone propionate and 50 mcg of salmeterol, as it has been shown to reduce the risk of acute exacerbations of COPD and improve quality of life 1.
Key Considerations for Wixela Use
- For asthma management, dosing varies based on severity, with options of 100/50 mcg, 250/50 mcg, or 500/50 mcg twice daily.
- The medication should be taken approximately 12 hours apart, with patients rinsing their mouth with water after each use to prevent oral thrush.
- Wixela combines an inhaled corticosteroid (fluticasone) that reduces airway inflammation with a long-acting beta-agonist (salmeterol) that relaxes airway muscles, providing dual action for symptom control.
- This medication is not for acute symptom relief and requires consistent use to maintain effectiveness.
- Patients should not exceed the prescribed dosage and should always have a rescue inhaler available for sudden symptoms.
Evidence-Based Recommendations
- The 2023 Canadian Thoracic Society guideline recommends the use of long-acting beta-agonist (LABA) and inhaled corticosteroid (ICS) combination therapy, such as Wixela, for patients with moderate to severe COPD 1.
- The guideline also suggests that LAMA/LABA single inhaled dual therapy is preferred over ICS/LABA inhaled combination therapy, considering the additional improvements in lung function and the lower rates of adverse events such as pneumonia.
- However, ICS/LABA combination therapy, such as Wixela, should be used in individuals with concomitant asthma.
Important Safety Information
- The safety of Wixela has been established, with a similar rate of adverse events compared to placebo 1.
- However, patients should be monitored for potential side effects, such as oral thrush, and should rinse their mouth with water after each use.
- Patients should also be advised not to exceed the prescribed dosage and to always have a rescue inhaler available for sudden symptoms.
From the Research
Recommended Use and Dosage of Wixela
The recommended use and dosage of Wixela (fluticasone/salmeterol) for chronic obstructive pulmonary disease (COPD) and asthma are as follows:
- Wixela is approved as a generic equivalent to Advair Diskus for patients with asthma whose symptoms are not controlled with inhaled corticosteroids alone and for those with COPD who are at a high risk for exacerbations 2.
- The dosing performance of Wixela is dependent on the patient's inspiratory capability, which may be impacted in disease populations such as those with severe COPD 3.
- Wixela has been shown to be bioequivalent to Advair Diskus in terms of therapeutic effects in the lung 4.
Bioequivalence and Efficacy
The bioequivalence of Wixela to Advair Diskus has been established through several studies:
- A randomized, double-blind, double-dummy, placebo-controlled, parallel-group study demonstrated that Wixela and Advair Diskus were bioequivalent for both co-primary endpoints of day 1 FEV1 AUC(0-12) and day 29 trough FEV1 4.
- A study comparing the effectiveness and safety of generic (Wixela) and brand-name (Advair Diskus) fluticasone-salmeterol among patients with COPD found that Wixela was associated with a nearly identical incidence of first moderate or severe COPD exacerbation and first pneumonia hospitalization 5.
- The in vitro performance of Wixela has been evaluated using severe COPD patient inhalation profiles, and the results demonstrate low flow dependency across the range of COPD patient profiles tested 3.
Treatment Options
Wixela represents a therapeutically equivalent new treatment option for use in the treatment of asthma and COPD: