Fluticasone furoate

Fluticasone Furoate ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use Fluticasone Furoate ELLIPTA is NOT indicated for the relief of acute bronchospasm. Fluticasone Furoate ELLIPTA is an inhaled corticosteroid indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use: Not indicated for relief of acute bronchospasm.

Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown. The precise mechanism through which fluticasone furoate affects asthma symptoms is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

• For oral inhalation only. • Maintenance treatment of asthma in adult and pediatric patients aged 12 years and older: The starting dosage, 1 actuation of Fluticasone Furoate ELLIPTA 100 mcg or Fluticasone Furoate ELLIPTA 200 mcg once daily, is based on prior asthma therapy and disease severity. • Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of Fluticasone Furoate ELLIPTA 50 mcg once daily.

Fluticasone Furoate ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate or any of the excipients. • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. • Severe hypersensitivity to milk proteins. • Demonstrated hypersensitivity to any ingredients.

• Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. • Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. • Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infections, ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. • Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to Fluticasone Furoate ELLIPTA.

Systemic and local corticosteroid use may result in the following: • Oropharyngeal Candidiasis • Immunosuppression and Risk of Infections • Hypercorticism and Adrenal Suppression • Reduction in BMD • Growth Effects in Pediatrics • Glaucoma and Cataracts Most common adverse reactions reported in ≥5% of adult and pediatric subjects aged 12 years and older are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection.

Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. Inhibitors of Cytochrome P450 3A4 Fluticasone furoate is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate. Caution should be exercised when considering the coadministration of Fluticasone Furoate ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors.

Store at room temperature between 68°F and 77°F (20°C and 25°C), excursions permitted from 59°F to 86°F (15°C to 30°C). Store in a dry place away from direct heat or sunlight. Fluticasone Furoate ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use.