What is Wixela Inhuber (Fluticasone/Salmeterol)?

From the Guidelines

Wixela Inhub is a prescription inhaler medication containing fluticasone propionate and salmeterol, used to treat asthma and COPD (Chronic Obstructive Pulmonary Disease), and should be used with caution due to the potential risk of pneumonia and other side effects, as noted in the 2017 GOLD report 1.

Key Points to Consider

• The medication is typically prescribed as 1-2 inhalations twice daily, with doses varying between 100/50 mcg, 250/50 mcg, or 500/50 mcg depending on condition severity.
• The fluticasone component is a corticosteroid that reduces airway inflammation, while salmeterol is a long-acting beta-agonist that relaxes airway muscles for improved breathing.
• Users should rinse their mouth after use to prevent thrush, and the medication should be used regularly as prescribed, not just during symptom flare-ups.
• It's essential to note that Wixela is a maintenance medication and won't provide immediate relief during an acute asthma attack, so patients should always have a rescue inhaler available.

Potential Side Effects and Risks

• Side effects may include throat irritation, hoarseness, and oral fungal infections, though these are generally manageable with proper technique and mouth rinsing.
• The 2011 study published in the Annals of Internal Medicine found that combination therapy with salmeterol-fluticasone was associated with a higher risk of serious adverse events and pneumonia compared to tiotropium monotherapy 1.
• The 2017 GOLD report also notes that regular treatment with inhaled corticosteroids increases the risk of pneumonia, especially in patients with severe disease 1.

Recommendations for Use

• The use of Wixela Inhub should be individualized and based on the patient's specific condition and medical history, with careful consideration of the potential benefits and risks, as recommended by the 2016 European Respiratory Journal review of national guidelines for COPD management in Europe 1.
• Patients with COPD should be treated with a combination of bronchodilators and inhaled corticosteroids, with the addition of other medications such as phosphodiesterase-4 inhibitors or antibiotics as needed, according to the 2017 GOLD report 1.
• Pulmonary rehabilitation programs can also provide improvements in respiratory symptoms, quality of life, and exercise capacity, as noted in the 2011 Annals of Internal Medicine study 1.

From the FDA Drug Label

Wixela Inhub® (wicks-EL-uh IN-hub) (fluticasone propionate and salmeterol inhalation powder, USP) for oral inhalation use Wixela Inhub® combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the long-acting beta2-adrenergic agonist (LABA) medicine salmeterol. Wixela Inhub is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in adults and children aged 4 years and older. It is also used to treat COPD as 1 inhalation 2 times each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups. Key points:

• Wixela Inhub is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
• It is not known if Wixela Inhub is safe and effective in children younger than 4 years.
• Wixela Inhub contains an ICS and a LABA, when an ICS and LABA are used together there is not a significant increased risk in hospitalizations and death from asthma problems 2.

From the Research

Wixela Inhub Overview

• Wixela Inhub is a dry powder inhaler (DPI) that delivers a fixed-dose combination of fluticasone propionate and salmeterol, approved as a generic equivalent to Advair Diskus for the treatment of asthma and chronic obstructive pulmonary disease (COPD) 3, 4, 5, 6.
• The dosing performance of DPIs, such as Wixela Inhub, is dependent on the patient's inspiratory capability, which may be impacted in disease populations such as those with severe COPD 3.

Bioequivalence and Efficacy

• Studies have demonstrated the bioequivalence of Wixela Inhub and Advair Diskus in terms of local therapeutic equivalence, with similar results in forced expiratory volume in 1 second (FEV1) area under the effect curve and trough FEV1 4, 5, 6.
• Wixela Inhub has been shown to be effective in treating asthma and COPD, with a low flow dependency observed in severe COPD patients, indicating that patients are likely to achieve a consistent inhaled dose 3.
• A comparative effectiveness and safety study found that generic Wixela Inhub and brand-name Advair Diskus had similar outcomes in terms of incidence of moderate or severe COPD exacerbation and pneumonia hospitalization 7.

Device Performance and Patient Use

• The Inhub inhaler has been shown to be robust and easy to use, suggesting that Wixela Inhub may provide an alternative option to Advair Diskus for patients with asthma or COPD requiring intervention with an ICS/LABA 5, 6.
• In vitro studies have demonstrated the comparable performance of Wixela Inhub and Advair Diskus in terms of total emitted dose and fine particle mass of fluticasone propionate and salmeterol 3.