Diagnosing nasal polyps

Chronic inflammation associated with nasal polyposis may be the underlying cause of nasal symptoms.^1,2 Defining symptoms last at least 12 weeks and include at least two of the following³:

Nasal congestion
or obstruction

Facial
pain/pressure

Rhinorrhea or
postnasal drip

Reduction or loss of
sense of smell and taste

Nasal polyps are common but may be difficult to visualize

Nasal polyps may be difficult to see during a routine nasal exam due to complexities of the nasal anatomy and/or widespread inflammation.^2,4-7

Up to 10 million adults in the United States have nasal polyps.^1,8

In the general population, the prevalence of nasal polyps has been reported to be up to 4%^9,10
Histopathologic evaluation of 1,944 endoscopic sinus surgery specimens removed during an 8-year period at one center found that 65% had evidence of nasal polyp tissue¹¹
In XHANCE pivotal trials, patients had moderate-to-severe congestion and evidence of nasal polyps, yet up to 86% of nasal polyps at baseline likely could not be readily visualized (did not extend below the inferior turbinate) during a routine exam with speculum¹²

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IMPORTANT SAFETY INFORMATION

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.

References:

Hull BP, Chandra RK. Refractory chronic rhinosinusitis with nasal polyposis. Otolaryngol Clin North Am. 2017;50(1):61-81.
Newton JR, Ah-See KW. A review of nasal polyposis. Ther Clin Risk Manag. 2008;4(2):507-512.
Orlandi RR, Kingdom TT, Hwang PH, et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol. 2016;6(suppl 1):S22-S209.
Zhong C, Jiang Z, Zhang X. Effect of distribution of nasal polyps in ostiomeatal complex on long-term outcomes after endoscopic surgery. Eur Arch Otorhinolaryngol. 2015;272(12):3757-3762.
Larsen PL, Tos M. Origin of nasal polyps: an endoscopic autopsy study. Laryngoscope. 2004;114(4):710-719.
Djupesland PG. Nasal drug delivery devices: characteristics and performance in a clinical perspective — a review. Drug Deliv Transl Res. 2013;3(1):42-62.
Liang J, Lane AP. Topical drug delivery for chronic rhinosinusitis. Curr Otorhinolaryngol Rep. 2013;1(1):51-60.
Djupesland PG, Vlckova I, Hewson G. Impact of baseline nasal polyp size and previous surgery on efficacy of fluticasone delivered with a novel device: a subgroup analysis. Am J Rhinol Allergy. 2010;24(4):291-295.
Settipane GA, Chafee FH. Nasal polyps in asthma and rhinitis. A review of 6,037 patients. J Allergy Clin Immunol. 1977;59(1):17-21.
Palmer JN, Messina JC, Biletch R, Grosel K, Mahmoud RA. A cross-sectional, population-based survey of U.S. adults with symptoms of chronic rhinosinusitis. Allergy Asthma Proc. 2019;40(1):48-56.
van den Boer C, Brutel G, de Vries N. Is routine histopathological examination of FESS material useful? Eur Arch Otorhinolaryngol. 2010;267(3):381-384.
Data on file. OptiNose US, Inc.