EFFICACY OF THE EXHALATION DELIVERY SYSTEM WITH FLUTICASONE IN PATIENTS WHO REMAIN SYMPTOMATIC ON STANDARD NASAL STEROID SPRAYS

Brent A. Senior, MD, Rodney J. Schlosser, MD, John Bosso, MD, and Zachary M. Soler, MD, MSc

Important Information

This study was funded by Optinose.

Optinose contributed to the study design, data interpretation, and writing of the report, as well as coordinating the data collection and analysis. The following authors have received compensation from Optinose: R.J. Schlosser, J. Bosso, and Z.M. Soler.

This publication contains information that is not consistent with the FDA-approved labeling for XHANCE. XHANCE is not indicated for the treatment of chronic rhinosinusitis without nasal polyps; the safety and efficacy of XHANCE for this use has not been established.

XHANCE is a corticosteriod indicated for the treatment of nasal polyps in patients 18 years of age and older.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:
Hypersensitivity to any ingredient in XHANCE.

WARNINGS AND PRECAUTIONS:

Local Nasal Effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.
Close monitoring for glaucoma and cataracts is warranted.
Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.
Immunosuppression: potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; 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.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.
Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.

ADVERSE REACTIONS:
The most common adverse reactions (incidence ≥ 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.

DRUG INTERACTIONS:
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.

USE IN SPECIFIC POPULATIONS:
Hepatic impairment. Monitor patients for signs of increased drug exposure.

INDICATION AND USAGE: XHANCE is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.

Please see full Prescribing Information, including Instructions for Use.