QBREXZA SIDE EFFECTS
- Generic Name: glycopyrronium cloth, 2.4%, for topical use
- Brand Name: Qbrexza
SIDE EFFECTS
The following adverse reactions are described in greater detail in other sections
- Worsening of Urinary Retention
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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02530281] and Trial 2 [NCT02530294]) of 459 subjects treated with Qbrexza once daily and 232 treated with vehicle, subjects were 9 to 76 years of age, 47% male, and the percentages of White, Black (including African Americans), and Asian subjects were 82%, 12%, and 1%, respectively.
Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with Qbrexza.
Table 1: Adverse Reactions Occurring in ≥2% of Subjects
| Adverse Reactions | Qbrexza (N=459) n (%) |
Vehicle (N=232) n (%) |
| Dry mouth | 111 (24.2%) | 13 (5.6%) |
| Mydriasis | 31 (6.8%) | 0 |
| Oropharyngeal pain | 26 (5.7%) | 3 (1.3%) |
| Headache | 23 (5.0%) | 5 (2.2%) |
| Urinary hesitation | 16 (3.5%) | 0 |
| Vision blurred | 16 (3.5%) | 0 |
| Nasal dryness | 12 (2.6%) | 1 (0.4%) |
| Dry throat | 12 (2.6%) | 0 |
| Dry eye | 11 (2.4%) | 1 (0.4%) |
| Dry skin | 10 (2.2%) | 0 |
| Constipation | 9 (2.0%) | 0 |
Table 2 shows the most frequently reported local skin reactions, which were relatively common in both the Qbrexza and vehicle groups.
Table 2: Local Skin Reactions
| Local Skin Reactions | Qbrexza (N=454)a n (%) |
Vehicle (N=231)a n (%) |
| Erythema | 77 (17.0%) | 39 (16.9%) |
| Burning/stinging | 64 (14.1%) | 39 (16.9%) |
| Pruritus | 37 (8.1%) | 14 (6.1%) |
| a Patients with a post-baseline local skin reaction assessment | ||
In an open-label safety trial (NCT02553798), 564 subjects were treated for up to an additional 44 weeks after completing Trial 1 or Trial 2. Adverse reactions occurring at a frequency ≥2.0% were: dry mouth (16.9%), vision blurred (6.7%), nasopharyngitis (5.8%), mydriasis (5.3%), urinary hesitation (4.2%), nasal dryness (3.6%), dry eye (2.9%), pharyngitis (2.2%), and application site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema [2.4%]).
SRC: NLM .