Experts Issue New Treatment Algorithm for Chronic Rhinosinusitis with Nasal Polyps That Highlights Role of XHANCE® In Stepwise Care
The algorithm was informed by evidence-based, peer-reviewed data supporting the use of therapeutic and interventional treatments to arrive at the recommended stepwise care paradigm. The growing number of medical and surgical treatment options available for patients with nasal polyps can cause confusion among providers regarding the optimal sequence for those treatment modalities. The algorithm seeks to lend order to treatment and serve as a basis for improving quality of care. The publication discusses considerations in a pathway for care that incorporates several new treatments approved in recent years into a logical stepwise escalation of medical care, including but not limited to standard nasal steroid sprays, EDS-FLU, surgery, implants and biologics.
"Over 85% of patients suffering from chronic rhinosinusitis with nasal polyps are frustrated with the lack of symptom relief they get with standard nasal steroids,"1 said
XHANCE was approved by the
"Our goal is to share an emerging logical stepped-care guidance similar to what is used in other disease areas such as asthma in which treatment is escalated stepwise in attempt to achieve a full response," said Dr.
In addition to
About Nasal Polyps
Nasal polyps are soft, noncancerous (or benign) protrusions high in the lining of the nasal passages or sinuses. Nasal polyps generally develop as part of the inflammatory process of chronic rhinosinusitis (CRS) and can worsen inflammatory blockage of normal ventilation and drainage from the sinuses. CRS is a chronic nasal inflammatory disease that may affect as many as 30 million adults in
Treatments for nasal polyps include, among others, standard topical intranasal steroid sprays, XHANCE, short bursts of oral steroids, surgery, implants and biologics.
Optinose is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.
XHANCE uses an Optinose Exhalation Delivery System (EDS™) designed to deliver a topically acting anti-inflammatory corticosteroid to the high and deep regions of the nasal cavity where nasal polyps originate. XHANCE was approved for the treatment of nasal polyps in patients 18 years of age or older by the U.S. Food and Drug Administration in September 2017.
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.
- 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.
Please see full Prescribing Information.
1 Palmer et al. Allergy and Asthma Proc. 2019;40(1):48-56.
2 Sindwani, R., Han, J. K., Soteres, D. F.,
3 Leopold, D. A., Elkayam, D.,
4 Pearlman AN, Chandra RK, Chang D, et al. Relationships between severity of chronic rhinosinusitis and nasal polyposis, asthma, and atopy. Am J Rhinol Allergy. 2009;23(2):145-148.
5 Bhattacharyya et al. Laryngoscope. 2019;129(9):1969-1975.
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