What is Wixela Inhub used for?

Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA208891). Cross-references to other label sections are left out.

Treatment of Asthma

Wixela Inhub® is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Wixela Inhub® should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA).

Important Limitation of Use:

Wixela Inhub® is NOT indicated for the relief of acute bronchospasm.

Maintenance Treatment of Chronic Obstructive Pulmonary Disease

Wixela Inhub® 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Wixela Inhub® 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Wixela Inhub® 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength Wixela Inhub® 500/50 over Wixela Inhub® 250/50 has not been demonstrated.

Important Limitation of Use:

Wixela Inhub® is NOT indicated for the relief of acute bronchospasm.

Source: DailyMed label, set id 3beef422-8a07-4a45-9ba6-414511e4b7e2, version 6, effective August 29, 2022. NDC 0378-9320, one of 4 listings for this product.