Xhance

— THERAPEUTIC CATEGORIES —
  • Miscellaneous respiratory disorders

Xhance Generic Name & Formulations

General Description

Fluticasone propionate 93mcg/spray; aqueous nasal spray.

Pharmacological Class

Steroid.

How Supplied

Spray—16mL (120 sprays)

Manufacturer

Generic Availability

NO

Mechanism of Action

Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. The precise mechanism through which fluticasone propionate affects nasal polyps and associated inflammatory symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. 

Xhance Indications

Indications

Chronic rhinosinusitis with or without nasal polyps.

Xhance Dosage and Administration

Adult

≥18yrs: 1 or 2 sprays in each nostril twice daily. Max total daily dose: 2 sprays in each nostril twice daily (744mcg/day).

Children

<18yrs: not established.

Administration

Administer by intranasal route only; avoid spraying directly on the nasal septum. Shake before each use. Prime by gently shaking and then pressing the bottle 7 times or until fine mist appears. Insert tapered tip of nosepiece deep into 1 nostril and place mouthpiece into mouth. Blow into mouthpiece, and while continuing to blow, push bottle up to actuate the spray pump.

Xhance Contraindications

Not Applicable

Xhance Boxed Warnings

Not Applicable

Xhance Warnings/Precautions

Warnings/Precautions

Maintain regular regimen. Do not exceed recommended dose. Respiratory tract tuberculosis. Systemic infections. Ocular herpes simplex. Immunosuppression. If exposed to measles or chickenpox, consider anti-infective prophylactic therapy. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with topical corticosteroids may exacerbate symptoms of adrenal insufficiency (eg, lassitude, depression). Recent nasal ulceration, surgery, trauma; avoid until healing has occurred. Change in vision, history of increased intraocular pressure, glaucoma, and/or cataracts: monitor closely; consider referral to an ophthalmologist if ocular symptoms develop or long-term use of Xhance. Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually), and candida infection or other nasal mucosal changes. Discontinue if septal perforation occurs. Discontinue if hypersensitivity reactions occur. Prolonged immobilization, family history of osteoporosis, postmenopausal, tobacco use, advanced age, poor nutrition: monitor bone mineral density. Hepatic impairment: monitor. Pregnancy. Nursing mothers.

Xhance Pharmacokinetics

Distribution

Volume of distribution: 4.2 L/kg. Human plasma protein bound at ~99%.

Metabolism

CYP3A4 pathway.

Elimination

Fecal, renal (<5%). Half-life: ~7.8 hours.

Xhance Interactions

Interactions

Concomitant strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole): not recommended. Additive effects with chronic use of drugs that can reduce bone mineral density (eg, anticonvulsants, oral corticosteroids): monitor.

Xhance Adverse Reactions

Adverse Reactions

Epistaxis, nasal septal ulceration/erythema, nasopharyngitis, nasal mucosal erythema/ulcerations, nasal congestion, acute sinusitis, headache, pharyngitis; impaired wound healing, reduced bone mineral density, HPA axis effects, reduced growth velocity in children.

Xhance Clinical Trials

See Literature

Xhance Note

Not Applicable

Xhance Patient Counseling

See Literature