XHANCE SIDE EFFECTS
- Generic Name: fluticasone propionate nasal spray, for intranasal use
- Brand Name: Xhance
- Drug Class: Corticosteroids, Intranasal
SIDE EFFECTS
Systemic and local corticosteroid use may result in the following:
- Local nasal effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing
- Cataracts and glaucoma
- Hypersensitivity reactions including anaphylaxis
- Immunosuppression.
- HPA axis effects, including growth reduction.
- Reduction in bone mineral density.
- Effect on Growth.
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.
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 subjects 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%) subjects 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 subjects, and more common than placebo.
Table 1. Summary of Adverse Reactions with XHANCE Reported in ≥ 3% of Subjects with Nasal Polyps and More Common Than Placebo in Placebo-Controlled Studies
| Adverse Reaction | Placebo (N = 161) n (%) |
XHANCE | |
| 186 mcg bid (N = 160) n (%) |
372 mcg bid (N = 161) n (%) |
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| Epistaxis1 | 4 (2.5) | 19 (11.9) | 16 (9.9) |
| Nasopharyngitis | 8 (5.0) | 3 (1.9) | 12 (7.5) |
| Nasal septal ulceration2 | 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 ulceration2 | 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) |
| bid = twice daily. 1Includes spontaneous adverse reaction reports 2Include ulcerations and erosions |
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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 subjects treated with XHANCE 186 mcg twice daily and 1.2% of subjects 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 subjects 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.
The adverse reactions observed during uncontrolled, open-label trials of 3 to 12 months duration in subjects with chronic sinusitis with and without nasal polyps receiving XHANCE 372 mcg twice daily were similar to the adverse reactions reported in clinical trials in patients with nasal polyps.
SRC: NLM .