XHANCE
Generic: FLUTICASONE PROPIONATE
Basic Information
Manufacturer
Paratek Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
NASAL
FDA Set ID
44fcea33-8cfa-3a5c-e063-6394a90aafb2
Indications & Usage
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.
( 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.
Adverse Reactions
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
( 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