Qbrexza (glycopyrronium) is a topical anticholinergic contained in a single-use, pre-moistened, medicated cloth for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older. 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. These highlights do not include all the information needed to use QBREXZA™ safely and effectively. See full prescribing information for QBREXZA.
QBREXZA (glycopyrronium) cloth, 2.4%, for topical use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older (1).
DOSAGE AND ADMINISTRATION
For topical use only. Apply Qbrexza once daily to both axillae using a single cloth (2).
DOSAGE FORMS AND STRENGTHS
Cloth: A single-use cloth pre-moistened with 2.4% glycopyrronium solution (3).
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) (4)
WARNINGS AND PRECAUTIONS
Worsening of urinary retention: Use with caution in patients with a history or presence of documented urinary retention (5.1).
Control of body temperature: In the presence of high ambient temperature, heat illness may occur; avoid use if patients develop generalized lack of sweating when exposed to hot or very warm environmental temperatures (5.2).
Operating machinery or an automobile: Transient blurred vision may occur with use of Qbrexza. If blurred vision occurs, discontinue use of Qbrexza until symptoms resolve; avoid operating a motor vehicle or other machinery until symptoms resolve (5.3).
Most common adverse reactions (incidence ?2%) are dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, vision blurred, nasal dryness, dry throat, dry eye, dry skin, constipation. Local skin reactions, including erythema, burning/stinging and pruritus were also common (>5%) (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Dermira at 1-877-337-5553 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Coadministration of Qbrexza with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of Qbrexza with other anticholinergic-containing drugs (7)
USE IN SPECIFIC POPULATIONS
Pediatric use: Safety and efficacy are not established in patients under 9 years of age (8.4).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.