In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due todecreased sweating) can occur with the use of anticholinergic drugs such as Qbrexza. Advise

patients using Qbrexza to watch for generalized lack of sweating when in hot or very warmenvironmental temperatures and to avoid use if not sweating under these conditions.

5.3 Operating Machinery or an Automobile

Transient blurred vision may occur with use of Qbrexza. If blurred vision occurs, the patientshould discontinue use until symptoms resolve. Patients should be warned not to engage in 

Page 3 of 10

activities that require clear vision such as operating a motor vehicle or other machinery, orperforming hazardous work until the symptoms have resolved.

6 ADVERSE REACTIONS

The following adverse reactions are described in greater detail in other sections

• Worsening of Urinary Retention [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved 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 (includingAfrican Americans), and Asian subjects were 82%, 12%, and 1%, respectively.

Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillaryhyperhidrosis 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 commonin 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

Page 4 of 10In 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%), andapplication site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema

[2.4%]).

7 DRUG INTERACTIONS

7.1 Anticholinergics