Dosing and Administration

Dosing Information for XHANCE¹

Please see full Prescribing Information and Instructions for Use for more information.

XHANCE is administered in each nostril twice daily

XHANCE is approved for¹:

1

spray per nostril BID* for the 186 mcg dose

*Total daily dose=372 mcg

30 days of treatment at this dosage requires 1 unit of XHANCE per month

2

sprays per nostril BID^† for the 372 mcg dose

^†Total daily dose=744 mcg

30 days of treatment at this dosage requires 2 units of XHANCE per month

Maximum total daily dosage should not exceed 2 sprays (372 mcg) in each nostril BID (744 mcg total per day)¹

Patients should use XHANCE at regular intervals since its effectiveness depends on regular use¹
The safety and efficacy of XHANCE when administered in excess of recommended doses have not been established¹

BID=twice daily.

XHANCE Dosing Card

Keep a reminder of the approved dosages of XHANCE.

How to administer XHANCE¹

Before using XHANCE

Not actual size.

left hand of a female patient holding XHANCE

Prime XHANCE by first gently shaking and then pressing the bottle 7 times or until a fine mist appears. Direct the spray into the air, away from the face.¹

When XHANCE has not been used for 7 days or more, prime the pump again by shaking and releasing 2 sprays into the air, away from the face¹
Shake XHANCE before each use¹
Administer by the nasal route only. Avoid spraying directly on the nasal septum¹

In a clinical trial questionnaire, most patients reported that XHANCE was somewhat or very easy to use²

Instructions on using XHANCE¹

Insert the tapered tip of the cone-shaped nosepiece deep into 1 nostril and form a tight seal between the nosepiece and the nostril.¹
Place the flexible mouthpiece into the mouth, bending as necessary to maintain a tight seal with the nostril.¹
While blowing into the mouthpiece, push the bottle up to actuate the spray.¹

To achieve intended drug deposition, it’s important to continue to blow through the mouth, not inhaling or exhaling through the nose¹
For a full dose, repeat the process in the other nostril. Administer 1 spray per nostril at the 186 mcg dose, and 2 sprays per nostril at the 372 mcg dose¹

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IMPORTANT SAFETY INFORMATION

INDICATIONS

XHANCE is a corticosteroid indicated for the treatment of:

Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.
Chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Hypersensitivity to any ingredient in XHANCE.

WARNINGS AND PRECAUTIONS:

Local nasal adverse reactions, including epistaxis, erosion, ulceration, and septal perforation can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. If a septal perforation is noted, discontinue XHANCE. Candida infections may also occur with treatment with XHANCE which may require treatment with appropriate local therapy and discontinuation of XHANCE. Patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma should not use XHANCE until healing has occurred.
Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term. Instruct patients to notify their healthcare provider if a change in vision occurs.
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 infections can occur, including 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. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
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. Observe patients postoperatively or during periods of stress for evidence of inadequate adrenal response. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. Inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to XHANCE.
Use with strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) is not recommended because increased systemic corticosteroid adverse effects may occur.
Decreases in bone mineral density have been observed with long-term oral inhalation of products containing corticosteroids into the lungs. Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids).
Nasal corticosteroids, including XHANCE, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of XHANCE has not been established in pediatric patients.

ADVERSE REACTIONS:

Chronic rhinosinusitis with nasal polyps: 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.

Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥ 3%) are epistaxis, headache, and nasopharyngitis.

USE IN SPECIFIC POPULATIONS:

Hepatic impairment. Monitor patients for signs of increased drug exposure.

Please see Full Prescribing Information pdf opensfull Prescribing Information, including Patient Information pdf opensPatient Information, for XHANCE.

References

Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2024.
Data on file. Study 3102. Paratek Pharmaceuticals, Inc.