QBREXZA SIDE EFFECTS

Last updated on MDtodate: 10/6/2022

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 .