Xhance

Q: Who makes Xhance?

Xhance is listed by 2 labelers in the FDA NDC directory, including OptiNose US, Inc., Paratek Pharmaceuticals, Inc..

fluticasone propionate · Spray, Metered · Nasal

Uses

1 INDICATIONS AND USAGE XHANCE is a corticosteroid indicated for the treatment of: Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. ( 1.1 ) Chronic rhinosinusitis without nasal polyps (CRSsNP) in adults. ( 1.2 ) 1.1 Chronic Rhinosinusitis with Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. 1.2 Chronic Rhinosinusitis without Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.

Dosage and administration

Recommended Dosage : 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily. ( 2.1 ) For nasal use only. Shake before use. Prime before initial use. ( 2.2 ) XHANCE is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of XHANCE is 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily (total daily dose of 372 mcg or 744 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril twice daily (total daily dose of 744 mcg). Patients should use XHANCE at regular intervals since its effectiveness depends on regular use. Individual patients will experience a variable time to onset and different degrees of symptom relief. The safety and efficacy of XHANCE when administered in excess of recommended doses have not been established. 2.2 Administration Information Shake XHANCE before each use. Administer XHANCE by the nasal route only. Avoid spraying directly on the nasal septum. Priming Before initial use, 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. When XHANCE has not been used for ≥ 7 days, prime the pump again by shaking and releasing 2 sprays into the air, away from the face. Administration Instructions XHANCE is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing (exhaling) into the mouthpiece of the device. To administer XHANCE, insert the tapered tip of the cone-shaped nosepiece deep into one nostril and form a tight seal between the nosepiece and the nostril. Next, place the flexible mouthpiece into the mouth, bending it as necessary to maintain a tight seal with the nostril. Blow into the mouthpiece, and while continuing to blow, push the bottle up to actuate the spray pump. Continuing to blow through the mouth, but not inhaling or exhaling through the nose, at the time of actuation is important to achieve intended drug deposition. Repeat the process in the other nostril for a full dose [see Instructions for Use ] .

Dosage forms and strengths

Nasal spray: Each spray delivers 93 mcg of fluticasone propionate. Nasal spray: 93 mcg of fluticasone propionate in each spray. ( 3 )

Contraindications

4 CONTRAINDICATIONS XHANCE is contraindicated in patients with hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.3 ) and Description ( 11 )] . Hypersensitivity to any ingredient in XHANCE. ( 4 )

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 adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma. ( 5.1 ) 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. ( 5.2 ) 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. ( 5.3 ) 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. ( 5.4 ) 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. ( 5.5 ) Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.7 ) 5.1 Local Nasal Adverse Reactions Epistaxis, Nasal Erosions and Ulcerations In placebo-controlled clinical trials of 16 weeks duration, epistaxis, nasal erosions, and nasal ulcerations were reported more frequently in patients treated with XHANCE than those who received placebo [see Adverse Reactions ( 6.1 )] . Nasal Septal Perforation Nasal septal perforations have been reported in patients following the nasal application of XHANCE. In placebo-controlled clinical trials of 16 weeks duration, nasal septal perforation was reported in 1 (0.3%) patient treated with XHANCE compared with none treated with placebo. The patient had a prior history of nasal/sinus surgery. Three (0.3%) patients treated with XHANCE in uncontrolled, open-label trials of 3 to 12 months duration developed nasal septal perforations. As with any long term topical treatment of the nasal cavity, patients using XHANCE over several months or longer should be examined periodically for possible changes in the nasal mucosa. If a septal perforation is noted, discontinue XHANCE. Avoid spraying XHANCE directly on the septum. Candida Infection In clinical trials with XHANCE, localized infections with Candida albicans have been observed. Eight (0.9%) patients in uncontrolled, open-label trials of 3 to 12 months duration developed Candida albicans infections (nasal, pharyngeal, esophageal or intestinal). If such an infection develops, it may require treatment with appropriate local therapy and discontinuation of XHANCE. Patients using XHANCE should be examined periodically for evidence of Candida infection in the nasal and oropharyngeal mucosa. Impaired Wound Healing Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma should avoid using XHANCE until healing has occurred. 5.2 Glaucoma and Cataracts Nasal and inhaled corticosteroids, including fluticasone propionate, may result in the development of glaucoma and/or cataracts. In placebo-controlled clinical trials of 16 weeks duration, cataracts were reported in 4 (1.2%) patients treated with XHANCE, compared with 3 (1.9%) patients treated with placebo. Among these patients, 2 patients treated with XHANCE reported subcapsular cataracts compared with none treated with placebo. Eleven patients (1.2%) in uncontrolled, open-label trials of 3 to 12 months duration developed new or worsening cataracts, of which none were subcapsular. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure (IOP), glaucoma, and/or cataracts. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term. 5.3 Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. XHANCE is contraindicated in patients with known hypersensitivity to fluticasone propionate or any of the ingredients of XHANCE. Discontinue XHANCE if such reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) occur [see Contraindications ( 4 ) and Adverse Reactions ( 6.1 )] . 5.4 Immunosuppression and Risk of Infection Persons who are using drugs that suppress the immune system, such as corticosteroids, including XHANCE, are more susceptible to infections than healthy individuals and may experience a worsening of existing infections. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible adults using corticosteroids. In such adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective Prescribing Information for VZIG and IG.) If chickenpox develops, treatment with antiviral agents may be considered.

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Local Nasal Adverse Reactions: [see Warnings and Precautions ( 5.1 )] Glaucoma and Cataracts [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions including Anaphylaxis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Immunosuppression and Risk of Infection [see Warnings and Precautions ( 5.4 )] Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.7 )] Effect on Growth [see Warnings and Precautions ( 5.8 )] CRSwNP: 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. ( 6.1 ) CRSsNP: The most common adverse reactions (incidence ≥ 3%) are epistaxis, headache, and nasopharyngitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-678-6673 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Chronic Rhinosinusitis with Nasal Polyps The safety data described below are based on two placebo-controlled clinical trials evaluating doses of a fluticasone propionate nasal spray with an exhalation delivery system from 93 mcg twice daily to 372 mcg twice daily. Both trials were 16-weeks in duration with an additional 8-week open-label extension. The trials included a total of 643 adult patients with bilateral nasal polyps and associated moderate or severe nasal congestion of which 161 received 93 mcg twice daily, 160 received 186 mcg twice daily, 161 received 372 mcg twice daily and 161 received placebo. The overall pooled safety data included 296 (46.0%) Female, 347 (54.0%) Male, 584 (90.8%) White, 39 (6.1%) Black, 9 (1.4%) Asian, and 11 (1.7%) patients classified as Other. Of these patients, 45 (7%) were 65 years of age or older. Table 1 displays adverse reactions with an incidence of ≥ 3% in the XHANCE 186 mcg and 372 mcg twice daily patients, and more common than placebo. Table 1. Summary of Adverse Reactions with XHANCE Reported in ≥ 3% of Patients with CRSwNP and More Common Than Placebo in Placebo-Controlled Studies XHANCE Adverse Reaction Placebo (N = 161) n (%) 186 mcg bid* (N = 160) n (%) 372 mcg bid^ (N = 161) n (%) *186 mcg bid = 1 spray per nostril twice daily ^372 mcg bid = 2 sprays per nostril twice daily 1 Includes spontaneous adverse reaction reports 2 Include ulcerations and erosions Epistaxis 1 4 (2.5) 19 (11.9) 16 (9.9) Nasopharyngitis 8 (5.0) 3 (1.9) 12 (7.5) Nasal septal ulceration 2 3 (1.9) 11 (6.9) 12 (7.5) Nasal congestion 6 (3.7) 7 (4.4) 9 (5.6) Acute sinusitis 6 (3.7) 7 (4.4) 8 (5.0) Headache 5 (3.1) 8 (5.0) 6 (3.7) Pharyngitis 2 (1.2) 2 (1.3) 5 (3.1) Nasal mucosal ulceration 2 2 (1.3) 6 (3.8) 4 (2.5) Nasal mucosal erythema 6 (3.7) 9 (5.6) 8 (5.0) Nasal septal erythema 3 (1.9) 6 (3.8) 7 (4.3) Other adverse reactions with XHANCE observed with an incidence < 3% but ≥ 1% and more common than placebo included: nasal dryness, sinusitis, oropharyngeal pain, toothache, intraocular pressure increase, dizziness, abdominal discomfort, and weight increase. 5.0% of patients treated with XHANCE 186 mcg twice daily and 1.2% of patients treated with 372 mcg twice daily discontinued from the clinical trials prior to the open-label extension because of adverse reactions compared to 4.3% of patients treated with placebo. There were no clinically relevant differences in the incidence of adverse reactions based on gender. Clinical trials did not include sufficient numbers of non-Caucasian patients or patients aged 65 years and older to determine whether they respond differently from Caucasian or younger patients, respectively. Chronic Rhinosinusitis without Nasal Polyps The safety of XHANCE was based on a pooled safety population that reflect the exposure of XHANCE in 367 adults with chronic rhinosinusitis with (CRSwNP) or without nasal polyps (CRSsNP) exposed for 24 weeks duration. XHANCE was studied in two randomized, placebo-controlled, multicenter trials (Trial 3 and Trial 4). Patients received either XHANCE 186 mcg (1 spray per nostril) twice daily, XHANCE 372 mcg (2 sprays per nostril) twice daily, or placebo delivered with an exhalation delivery system. The pooled safety population had a mean age of 49 years [age range: 18 to 87], and were 55% male, 94% White, 96% non-Hispanic or Latino, 4% Black or African American, and 2% Asian. In these trials, 1.6% of patients treated with XHANCE 186 mcg (1 spray per nostril) twice daily and 1.6% of patients treated with 372 mcg (2 sprays per nostril) twice daily discontinued treatment due to adverse reactions compared to 2.7% of patients treated with placebo. The most common adverse reactions that occurred at a rate of ≥ 3% in patients treated with XHANCE and at a higher rate in at least one treatment group than placebo from the pooled safety population (Trials 3 and 4) are shown in Table 2. Table 2.

Drug interactions

Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur. Ritonavir A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology ( 12.3 )] . During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate products with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Ketoconazole Coadministration of orally inhaled fluticasone propionate (1000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

Use in specific populations

Hepatic impairment: Monitor patients for signs of increased drug exposure. ( 8.6 ) 8.1 Pregnancy Risk Summary Available data from published literature on the use of inhaled or nasal fluticasone propionate in pregnant women have not reported a clear association with adverse developmental outcomes. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight, and/or skeletal variations in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis. However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis ( see Data ). Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, fluticasone propionate was teratogenic in both species. Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately equivalent to the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). The rat no observed adverse effect level (NOAEL) was observed at approximately 0.4 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 30 mcg/kg/day). Cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately 0.3 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 45 mcg/kg/day). The mouse NOAEL was observed with a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). In an embryofetal development study with pregnant rats dosed by the inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 0.34 times the MRHDID (on a mcg/m 2 basis with a maternal inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity. The NOAEL was observed with a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal inhalation dose of 5.5 mcg/kg/day). In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.02 times the MRHDID and higher (on a mcg/m 2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). Teratogenicity was evident based upon a finding of cleft palate for 1 fetus at a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 4 mcg/kg/day). The NOAEL was observed in rabbit fetuses with a dose approximately 0.002 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. In a pre- and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation (Gestation Day 17 to Postpartum Day 22), fluticasone propionate was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 0.7 times the MRHDID (on a mcg/m 2 basis with maternal subcutaneous doses up to 50 mcg/kg/day). 8.2 Lactation Risk Summary There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Fluticasone propionate is present in rat milk ( see Data ). Other corticosteroids have been detected in human milk. However, fluticasone propionate concentrations in plasma after orally inhaled therapeutic doses are low, and therefore, concentrations in human breast milk are likely to be correspondingly low [see Clinical Pharmacology ( 12.3 )] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XHANCE and any potential adverse effects on the breastfed child from XHANCE or from the underlying maternal condition. Data Subcutaneous administration of tritiated fluticasone propionate at a dose in lactating rats approximately 0.1 times the MRHDID for adults (on a mcg/m 2 basis) resulted in measurable levels in milk. 8.4 Pediatric Use The safety and effectiveness of XHANCE in pediatric patients have not been established. Effects on Growth Controlled clinical trials have shown that nasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied.

Pregnancy

8.1 Pregnancy Risk Summary Available data from published literature on the use of inhaled or nasal fluticasone propionate in pregnant women have not reported a clear association with adverse developmental outcomes. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight, and/or skeletal variations in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis. However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis ( see Data ). Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, fluticasone propionate was teratogenic in both species. Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately equivalent to the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). The rat no observed adverse effect level (NOAEL) was observed at approximately 0.4 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 30 mcg/kg/day). Cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately 0.3 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 45 mcg/kg/day). The mouse NOAEL was observed with a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). In an embryofetal development study with pregnant rats dosed by the inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 0.34 times the MRHDID (on a mcg/m 2 basis with a maternal inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity. The NOAEL was observed with a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal inhalation dose of 5.5 mcg/kg/day). In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.02 times the MRHDID and higher (on a mcg/m 2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). Teratogenicity was evident based upon a finding of cleft palate for 1 fetus at a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 4 mcg/kg/day). The NOAEL was observed in rabbit fetuses with a dose approximately 0.002 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. In a pre- and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation (Gestation Day 17 to Postpartum Day 22), fluticasone propionate was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 0.7 times the MRHDID (on a mcg/m 2 basis with maternal subcutaneous doses up to 50 mcg/kg/day).

Pediatric use

8.4 Pediatric Use The safety and effectiveness of XHANCE in pediatric patients have not been established. Effects on Growth Controlled clinical trials have shown that nasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving nasal corticosteroids should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. Controlled clinical trials have shown that corticosteroids orally inhaled into the lungs may cause a reduction in growth in pediatric patients. In these trials, the mean reduction in growth velocity was approximately 1 cm/year (range: 0.3 to 1.8 cm/year) and appeared to depend upon dose and duration of exposure. The effects on growth velocity of treatment with corticosteroids orally inhaled into the lungs for over 1 year, including the impact on final adult height, are unknown. The growth of children and adolescents receiving corticosteroids should be monitored routinely (e.g., via stadiometry) [see Warnings and Precautions ( 5.8 )] .

Geriatric use

8.5 Geriatric Use Clinical trials of XHANCE for Chronic Rhinosinusitis with Nasal Polyps did not include sufficient numbers of patients aged 65 years and older to determine whether they responded differently than younger patients. Other reported clinical experience with fluticasone administered nasally or orally inhaled has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. There were 82 patients 65 years of age and older in clinical trials for Chronic Rhinosinusitis without Nasal Polyps [see Clinical Studies ( 14 )] . Of the total number of XHANCE-treated patients in these studies, 51 (14%) were 65 years of age and older. No overall differences in safety and effectiveness of XHANCE have been observed between patients 65 years of age and older and younger adult patients.

Overdosage

Overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions ( 5.5 )] .

Description

The active component of XHANCE is fluticasone propionate, a corticosteroid, having the chemical name S -(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3oxoandrosta-1,4-diene-17β-carbothioate, 17‑propionate and the following chemical structure: Fluticasone propionate is a white powder with a molecular weight of 500.57, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethylformamide, sparingly soluble in acetone and dichloromethane, and slightly soluble in 96% ethanol. XHANCE (fluticasone propionate) nasal spray, 93 mcg, for nasal administration, with an exhalation delivery system that delivers an aqueous suspension of microfine fluticasone propionate having a particle size distribution in the range of 0 to 5 microns for topical nasal administration by means of a metering, atomizing spray pump and exhaled breath. XHANCE also contains benzalkonium chloride, carboxymethylcellulose sodium, dextrose, edetate disodium dihydrate, microcrystalline cellulose, polysorbate 80, purified water, and sodium hydroxide and hydrochloric acid (to adjust pH), and has a pH between 5 and 7. Before initial use, prime XHANCE by gently shaking and then pressing the amber glass bottle 7 times or until a fine mist appears. When XHANCE has not been used for ≥ 7 days, prime again by releasing 2 sprays into the air, away from the face [see Dosage and Administration ( 2.2 ) and Instructions for Use ] . After priming, each spray delivers 93 mcg of fluticasone propionate in an aqueous suspension through the cone-shaped nosepiece. The system also has a flexible mouthpiece. Within the device is a non‑removable amber glass bottle with a metering spray pump, an applicator, and a valve that prevents release of breath until the bottle is pressed. A base covers the bottom of the bottle, and a removable orange cap covers both the nosepiece and mouthpiece. Chemical Structure

Mechanism of action

12.1 Mechanism of Action Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results. The clinical significance of these findings is unknown. The precise mechanism through which fluticasone propionate affects CRSsNP and CRSwNP and associated inflammatory symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. The anti-inflammatory action of corticosteroids contributes to their efficacy. In 7 trials in adults, fluticasone propionate nasal spray decreased nasal mucosal eosinophils in 66% of patients (35% for placebo) and basophils in 39% of patients (28% for placebo). In addition, studies suggest that carbon dioxide, which is present in the exhaled breath delivered into the nose through the device, may influence inflammatory mediator activity and neuropeptide activity, possibly through mechanisms of action that also include removal of nitric oxide, change in pH, or positive pressure. The direct relationship of these findings to long-term symptom relief is not known.

How supplied

(fluticasone propionate) nasal spray is supplied as a non-removable amber glass bottle fitted with a metered-dose manual spray pump unit inside the white XHANCE device with a nasal applicator, valve mechanism, asymmetrical cone-shaped nosepiece, flexible mouthpiece, base, and orange cap in a box of 1. Each metered spray delivers 93 mcg of fluticasone propionate in an aqueous suspension through the cone shaped nosepiece. They are supplied as follows: One (1) bottle net fill content of 16 mL that, after priming, will provide 120 metered sprays (NDC 71715-003-31) with FDA approved Patient Labeling [see Instructions for Use ]. The bottle should be discarded after 120 metered sprays even though the bottle is not empty. Beyond 120 metered sprays, the correct amount of medication in each metered spray cannot be assured. One (1) bottle net fill content of 6.4 mL that, after priming, will provide 28 metered sprays (NDC 71715-003-32) with FDA approved Patient Labeling [see Instructions for Use ]. The bottle should be discarded after 28 metered sprays even though the bottle is not empty. Beyond 28 metered sprays, the correct amount of medication in each metered spray cannot be assured. Store at room temperature (between 15°C and 25°C; 59°F and 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Avoid exposure to extreme heat, cold or light. Shake XHANCE before each use.

Patient information

Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Local Nasal Adverse Reactions Inform patients that treatment with XHANCE may lead to adverse reactions, which include epistaxis, nasal erosions, and nasal ulceration. Candida infection may also occur with treatment with XHANCE. In addition, XHANCE has been associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma should not use XHANCE until healing has occurred [see Warnings and Precautions ( 5.1 )] . Glaucoma and Cataracts Inform patients that glaucoma and cataracts are associated with long-term use of nasal and orally inhaled corticosteroids, including fluticasone propionate, and may increase the risk of some eye problems. Consider regular eye exams. Advise patients to notify their healthcare providers if a change in vision is noted while using XHANCE [see Warnings and Precautions ( 5.2 )] . Hypersensitivity Reactions, Including Anaphylaxis Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, contact dermatitis, rash, bronchospasm, and hypotension, may occur after administration of fluticasone. If such reactions occur during use with XHANCE, patients should discontinue use of the product [see Warnings and Precautions ( 5.3 )] . Immunosuppression and Risk of Infection Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles, and if they are exposed to consult their healthcare provider without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions ( 5.4 )] . Hypercorticism and Adrenal Suppression Advise patients that XHANCE may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to XHANCE [see Warnings and Precautions ( 5.5 )] . Reduction in Bone Mineral Density Advise patients who are at an increased risk for decreased bone mineral density that the use of corticosteroids may pose an additional risk [see Warnings and Precautions ( 5.7 )] . Reduced Growth Velocity The safety and effectiveness of XHANCE use in pediatric patients has not been established. Inform patients that corticosteroids administered by oral inhalation into the lungs or nasally may cause a reduction in growth velocity when administered to pediatric patients [see Warnings and Precautions ( 5.8 )] . Use Twice Daily for Best Effect Inform patients that they should use XHANCE on a regular basis as directed. XHANCE, like other corticosteroids, does not have an immediate effect on CRSsNP or CRSwNP or symptoms. Individual patients will experience a variable time to onset and degree of symptom relief and the full benefit may not be achieved until treatment has been administered for up to 16 weeks or longer. Maximum benefit may not be reached for a period of months. Patients should not increase the prescribed dosage, but should contact their healthcare providers if symptoms do not improve or if the condition worsens. If a patient missed a dose, the patient should be advised to take the dose as soon as they remember. The patient should not take more than the recommended dose for the day. Keep Spray Out of Eyes and Mouth Inform patients to avoid spraying XHANCE in their eyes and mouth. How to Use XHANCE It is important for patients to understand how to correctly administer XHANCE nasal spray using the exhalation delivery system. Advise the patient to carefully read the patient Instructions for Use . Any questions regarding use that the patient has should be directed to the physician or pharmacist. Advise the patient to shake before each use. The patient should note the difference in appearance of the cone-shaped, non-flexible nosepiece and the longer flexible mouthpiece. The patient should be instructed to gently insert the tapered tip of the cone-shaped nosepiece deeply into the nose in order to gently expand the nasal passage and to create a tight seal between the nosepiece and the nostril. A seal must be maintained as the patient blows into the mouthpiece and actuates the spray pump. To actuate the device, patients should be advised to push the bottle up while continuing to blow forcefully into the mouthpiece. Within the device is a valve that prevents the release of breath until the bottle is pushed. Pushing the bottle also actuates the spray pump, releasing a metered dose of aerosolized medication while simultaneously allowing a “burst” of exhaled breath to pass through the device. This helps deliver the medication deep into the patient’s nose. Patients should be advised not to try to inhale (e.g., “sniff”) when blowing (exhaling) into the mouthpiece. Patients should be advised not to block the other nostril because the exhaled breath must pass around the back of the nasal septum and out the other side of the nose. Distributed by: Paratek Pharmaceuticals, Inc. King of Prussia, PA 19406 XHANCE ® is a registered trademark of Paratek Pharmaceuticals, Inc. and/or its affiliated companies. Patented. See www.xhance.com/patents ©2026 Paratek Pharmaceuticals, Inc. All rights reserved.

Label text from the FDA structured product label by Paratek Pharmaceuticals, Inc. (revised May 19, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Fluticasone Propionate in 2 products

Xhance NDC products (2)

NDC	Strength & form	Labeler	Type
71143-375	Fluticasone Propionate 93 ug/1 Spray, Metered	OptiNose US, Inc.	NDA
71715-003	Fluticasone Propionate 93 ug/1 Spray, Metered	Paratek Pharmaceuticals, Inc.	NDA

Frequently asked questions

What is Xhance used for?

What are the side effects of Xhance?

Who makes Xhance?

Xhance is listed by 2 labelers in the FDA NDC directory, including OptiNose US, Inc., Paratek Pharmaceuticals, Inc..