Qbrexza

QBREXZA- glycopyrronium tosylate cloth
Journey Medical Corporation

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.

After applying Qbrexza, discard the cloth in the household trash out of reach of children and others. 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 New or Worsening Urinary Retention

New or worsening signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder) have occurred in patients taking Qbrexza with or without a history of documented urinary retention. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop.

Qbrexza should be used with caution in patients with prostatic hypertrophy or bladder-neck obstruction.

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.

5.4 Risk of Accidental Exposure

Cases of accidental exposure resulting in mydriasis, anisocoria, and blurred vision have been reported in postmarketing surveillance of Qbrexza. The exposures occurred when children accessed Qbrexza wipes discarded in trash or when patients touched the periocular area after using Qbrexza. In most cases, the mydriasis, anisocoria, and blurred vision were temporary and resolved within one week following exposure. The risk of accidental exposure was increased in these cases by not adhering to recommendations for the appropriate use of Qbrexza.

Strict adherence to the recommended hand washing after use and disposal instructions is of the utmost importance to prevent accidental exposure. [see Dosage and Administration (2) ].

6 ADVERSE REACTIONS

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

• New or Worsening 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%]).