XHANCE uses an Optinose® Exhalation Delivery System (EDS) that is designed to deliver medication high and deep in the nasal passages to regions where nasal polyps originate and sinuses drain and ventilate.1,2
IMPORTANT SAFETY INFORMATION for XHANCE (fluticasone propionate) nasal spray, 93 mcg
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.
- 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.
- Assess for decrease in bone mineral density initially and periodically thereafter.
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.
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.
INDICATIONS 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 at www.XHANCE.com.
- Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
- Data on file. OptiNose US, Inc.