Qbrexza

QBREXZA- glycopyrronium tosylate cloth
Dermira, Inc.

1 INDICATIONS AND USAGE

Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.

2 DOSAGE AND ADMINISTRATION

For topical use only.

Qbrexza is for topical use in the underarm area only and not for use in other body areas.

Qbrexza is administered by a single-use pre-moistened cloth packaged in individual pouches. Qbrexza should be applied to clean dry skin on the underarm areas only. Qbrexza should not be used more frequently than once every 24 hours.

Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply Qbrexza to both underarms.

Wash hands immediately with soap and water after applying and discarding the Qbrexza cloth. Qbrexza may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of Qbrexza to the periocular area [see Warnings and Precautions (5.3)].

Do not apply Qbrexza to broken skin. Avoid using Qbrexza with occlusive dressings.

3 DOSAGE FORMS AND STRENGTHS

Cloth: A single-use cloth pre-moistened with 2.4% glycopyrronium solution

4 CONTRAINDICATIONS

Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of Qbrexza (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).

5 WARNINGS AND PRECAUTIONS

5.1 Worsening of Urinary Retention

Qbrexza should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop.

Patients with a history of urinary retention were not included in the clinical studies.

5.2 Control of Body Temperature

In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased 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 warm environmental 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 patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing 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 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
a Patients with a post-baseline local skin reaction assessment
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%)

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%]).

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