Introduction
Xhance (fluticasone propionate) is an FDA-approved nasal corticosteroid spray specifically designed for the topical treatment of chronic rhinosinusitis with nasal polyps in patients aged 18 years and older. It utilizes a novel exhalation delivery system (EDS) that enables improved medication deposition to the sinonasal passages compared to conventional nasal sprays.
Mechanism of Action
Fluticasone propionate is a synthetic corticosteroid with potent anti-inflammatory properties. It binds to glucocorticoid receptors in the nasal mucosa, inhibiting multiple inflammatory cytokines including interleukin (IL)-1, IL-4, IL-5, IL-6, IL-8, and tumor necrosis factor-alpha. This action reduces mucosal inflammation, edema, and nasal polyp size. The EDS technology creates a closed-loop system that allows the medication to be delivered deeper into the nasal passages during exhalation, bypassing the nasal valve and reaching affected areas more effectively.
Indications
- Treatment of chronic rhinosinusitis with nasal polyps in adults (18 years and older)
- Not indicated for the relief of acute symptoms
Dosage and Administration
Standard dosing: 1-2 sprays per nostril twice daily (total daily dose: 372 mcg fluticasone) Administration technique:1. Prime the device before first use (pump 7 times until fine spray appears) 2. Blow nose gently to clear nasal passages 3. Place device tip in nostril, forming a seal 4. Close opposite nostril with finger 5. Exhale gently into device while simultaneously activating spray 6. Breathe in gently through nose and out through mouth
Special populations:- Hepatic impairment: Use with caution
- Renal impairment: No dosage adjustment required
- Elderly: No dosage adjustment required
Pharmacokinetics
Absorption: Systemic absorption is minimal (<2%) due to low bioavailability from nasal mucosa and extensive first-pass metabolism Distribution: Volume of distribution approximately 4.2 L/kg; 91% protein-bound Metabolism: Extensive hepatic metabolism via CYP3A4 to inactive metabolites Elimination: Primarily excreted in feces (<5% in urine); elimination half-life approximately 14.4 hoursContraindications
- Hypersensitivity to fluticasone propionate or any component of the formulation
- Recent nasal surgery or nasal trauma (until healed)
- Untreated localized nasal infections
Warnings and Precautions
- Nasal septal perforation: Monitor patients periodically
- Candida infection: May occur in nose and pharynx
- Immunosuppression: Potential increased risk of infections
- Glaucoma and cataracts: Intraocular pressure should be monitored regularly
- Hypothalamic-pituitary-adrenal (HPA) axis suppression: Possible with higher than recommended doses
- Reduced growth velocity: Monitor pediatric patients if used off-label
Drug Interactions
- Strong CYP3A4 inhibitors (ketoconazole, ritonavir): May increase fluticasone systemic exposure
- Other corticosteroids: Additive systemic effects possible
- Live vaccines: Avoid administration during treatment
Adverse Effects
Common (≥2%):- Nasal discomfort (14%)
- Epistaxis (11%)
- Headache (5%)
- Nasal ulceration (4%)
- Pharyngitis (3%)
- Nasal septal perforation
- Severe epistaxis
- Ocular hypertension/glaucoma
- Hypersensitivity reactions
- Adrenal insufficiency
Monitoring Parameters
- Nasal examination at regular intervals for signs of irritation, ulceration, or perforation
- Assessment of nasal polyp response and symptom control
- Intraocular pressure in patients with glaucoma risk factors
- Growth monitoring in pediatric patients (if used off-label)
- Signs of HPA axis suppression with long-term use
- Monitoring for signs of nasal or pharyngeal candidiasis
Patient Education
- Proper administration technique is crucial for effectiveness
- Use regularly as prescribed; not for immediate symptom relief
- Prime device before first use and if not used for >14 days
- Report any nasal pain, bleeding, or vision changes promptly
- Avoid spraying directly onto nasal septum
- Rinse mouth after use if experiencing post-nasal drip
- Do not share device with others
- Keep device clean and replace as recommended
- Contact healthcare provider if symptoms worsen or no improvement after 4 weeks
References
1. FDA Prescribing Information: Xhance (fluticasone propionate) nasal spray. 2021 2. Sindwani R, Han JK, Soteres DF, et al. NAVIGATE I: Randomized, double-blind trial of the exhalation delivery system with fluticasone for chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy. 2019;33(1):26-35 3. Tos M, Sasaki CT. Efficacy of fluticasone exhalation delivery system in chronic rhinosinusitis: NAVIGATE II study. Laryngoscope. 2021;131(1):30-37 4. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2023 [cited 2023 Nov 15] 5. UpToDate: Fluticasone (nasal). Waltham (MA): Wolters Kluwer Health; 2023