About nasal polyps

Nasal polyps are benign growths that can arise from inflamed tissue high and deep in the nasal passages.¹ Evidence suggests that conditions that trigger chronic inflammation in the nose and/or nasal sinuses can promote nasal polyposis.^2,3 Nasal polyposis is a phenotype of chronic rhinosinusitis (CRS).^1,3

CRS is an inflammatory condition commonly divided into 2 main subgroups: CRS with and without nasal polyps.²

Symptoms of nasal polyps include at least two out of four cardinal symptoms that persist for at least 12 consecutive weeks²:

Nasal congestion
or obstruction

Facial
pain/pressure

Rhinorrhea or
postnasal drip

Reduction or loss of
sense of smell and taste

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

Nasal polyps are common but may be difficult to visualize

Up to 10 million adults in the United States have nasal polyps.^3,4

In the general population, the prevalence of nasal polyps has been reported to be up to 4%^6,7
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 tissue⁸
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 speculum⁹

Graphic of view of nasal anatomy using a speculum in the middle turbinate

Graphic of view of nasal anatomy using an endoscope showing a nasal polyp in the middle turbinate

Nasal polyps reside high and deep in the nasal passages

Graphic of nasal passages showing polyps, that OMC is located behind the middle turbinate, and where the superior, middle, and inferior turbinates are located

Graphic of nasal passages showing polyps, middle meatus location, and where the superior, middle, and inferior turbinates are located

Chronic inflammation accompanied by polypoid tissue in the middle meatus obstructs ventilation and drainage¹

The ostiomeatal complex (OMC) is a region where nasal polyps usually originate and through which most sinuses drain and ventilate.^10-13

Complexities of the nasal anatomy also make it difficult for an anti-inflammatory to reach high and deep in the nasal passages, including the OMC
Nasal polyps may not be visible during a routine nasal exam

Review peer insight that may help physicians diagnose nasal polyps.

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:
Hypersensitivity to any ingredient in XHANCE.

WARNINGS AND PRECAUTIONS:

Local Nasal Adverse Reactions: 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 and Risk of Infection: 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
XHANCE is a corticosteroid indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in patients 18 years of age or older.

Please see Full Prescribing Information pdf opensfull Prescribing Information, including Instructions for Use.

References:

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.
Hull BP, Chandra RK. Refractory chronic rhinosinusitis with nasal polyposis. Otolaryngol Clin North Am. 2017;50(1):61-81.
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.
Lam K, Schleimer R, Kern RC. The etiology and pathogenesis of chronic rhinosinusitis: a review of current hypotheses. Curr Allergy Asthma Rep. 2015;15(7):41.
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.
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.