at Week 4 (mg/5 minutes):

Median -81 -66 -79 -58

25th percentile, 75th percentile -149, -40 -106, -28 -144, -45 -122, -21

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Qbrexza is supplied as:

A single-use cloth pre-moistened with a 2.4% glycopyrronium solution in a pouch

Carton of 30 pouches NDC 70428-011-12

16.2 Storage and Handling

Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C

(59° - 86°F) [See USP Controlled Room Temperature].

Qbrexza is flammable; keep away from heat or flame.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Worsening of Urinary Retention

Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passingurine, distended bladder). Instruct patients to discontinue use and consult a physician

immediately should any of these signs or symptoms develop.

Control of Body Temperature (Risk of Overheating or Heat Illness)In the presence of high ambient temperature, heat illness due to decreased sweating can occurwith 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 toavoid use if not sweating under these conditions.

Operating Machinery or an Automobile

Transient blurred vision may occur with Qbrexza. If this occurs, instruct patients to contact theirhealthcare provider, discontinue use of Qbrexza and avoid operating a motor vehicle or other

machinery, or performing hazardous work until symptoms resolve. 

Page 10 of 10Instructions for Administering QbrexzaIt is important for patients to understand how to correctly apply Qbrexza (see Patient

Information).

• Instruct patients to use one cloth to apply Qbrexza to both axillae by wiping the cloth acrossone underarm, ONE TIME.

• Using the same cloth, apply the medication to the other underarm, ONE TIME.

• Inform patients that Qbrexza can cause temporary dilation of the pupils and blurred vision ifit comes in contact with the eyes.

• Instruct patients to wash their hands with soap and water immediately after discarding theused cloth.

• Remind patients not to apply Qbrexza to other body areas or to broken skin. Instruct

patients to avoid using Qbrexza with occlusive dressings.

• Qbrexza is flammable; avoid use near heat or flame.

Manufactured for:

Dermira, Inc.

Menlo Park, CA 94025

Version 1, June 2018