XHANCE

XHANCE is an FDA-registered drug product whose active ingredient is FLUTICASONE PROPIONATE. It is labelled by Paratek Pharmaceuticals, Inc. taken by nasal and marketed as a human prescription drug product. Identifiers on file: NDC 71715-003, application NDA209022, label effective 20260519. It is one of 50 FDA drug label records sharing the active ingredient FLUTICASONE PROPIONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FLUTICASONE PROPIONATE are most often described in connection with: chronic rhinosinusitis, nasal polyps, crswnp adults, xhance indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

2 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 ] .

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 )

6 ADVERSE REACTIONS 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. Summary of Adverse Reactions with XHANCE Reported in ≥ 3% of Patients and More Common Than Placebo from Pooled Safety Population (Trials 3 and 4) 1 XHANCE Adverse Reaction Placebo (N = 187) n (%) 186 mcg bid* (N = 184) n (%) 372 mcg bid^ (N = 183) n (%) *186 mcg bid = 1 spray per nostril twice daily ^372 mcg bid = 2 sprays per nostril twice daily 1 Patients in Trial 3 included adults with CRSsNP and Trial 4 included adults with CRSsNP and CRSwNP Epistaxis 1 (0.5%) 9 (4.9%) 20 (10.9%) Headache 7 (3.7%) 4 (2.2%) 10 (5.5%) Nasopharyngitis 8 (4.3%) 9 (4.9%) 7 (3.8%) 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of XHANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye disorders: central serous chorioretinopathy Respiratory, thoracic, and mediastinal disorders: dysphonia, nasal discomfort, and nasal dryness Skin and subcutaneous tissue disorders: pruritus, rash

FDA lists 50 drug label records with FLUTICASONE PROPIONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is XHANCE used for?
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 …

Who makes XHANCE?
Paratek Pharmaceuticals, Inc. is the labeler of record for XHANCE. 50 FDA label records share the active ingredient FLUTICASONE PROPIONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does XHANCE come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is XHANCE prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FLUTICASONE PROPIONATE?
Yes. 50 FDA drug label records list FLUTICASONE PROPIONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has XHANCE been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.