HIGHLIGHTS OF PRESCRIBING INFORMATION

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 primaryaxillary hyperhidrosis in adults and pediatric patients 9 years of ageand older (1).

----------------------DOSAGE AND ADMINISTRATION-----------------------

For topical use only. Apply Qbrexza once daily to both axillae using asingle cloth (2).

---------------------DOSAGE FORMS AND STRENGTHS----------------------

Cloth: A single-use cloth pre-moistened with 2.4% glycopyrroniumsolution (3).

-------------------------------CONTRAINDICATIONS------------------------------

Qbrexza is contraindicated in patients with medical conditions that canbe exacerbated by the anticholinergic effect of Qbrexza (e.g.,glaucoma, paralytic ileus, unstable cardiovascular status in acute

hemorrhage, severe ulcerative colitis, toxic megacolon complicatingulcerative colitis, myasthenia gravis, Sjogren’s syndrome) (4).

-----------------------WARNINGS AND PRECAUTIONS------------------------

• Worsening of urinary retention: Use with caution in patients with ahistory or presence of documented urinary retention (5.1)

• Control of body temperature: In the presence of high ambienttemperature, heat illness may occur; avoid use if patients develop

generalized lack of sweating when exposed to hot or very warmenvironmental temperatures (5.2).

• Operating machinery or an automobile: Transient blurred vision mayoccur with use of Qbrexza. If blurred vision occurs, discontinue useof Qbrexza until symptoms resolve; avoid operating a motor vehicle

or other machinery until symptoms resolve (5.3).

------------------------------ADVERSE REACTIONS-------------------------------

Most common adverse reactions (incidence ≥2%) are dry mouth,mydriasis, oropharyngeal pain, headache, urinary hesitation, visionblurred, nasal dryness, dry throat, dry eye, dry skin, constipation. Local

skin reactions, including erythema, burning/stinging and pruritus werealso common (>5%) (6.1).

------------------------------DRUG INTERACTIONS-------------------------------

Coadministration of Qbrexza with anticholinergic medications mayresult in additive interaction leading to an increase in anticholinergicadverse effects. Avoid coadministration of Qbrexza with other

anticholinergic-containing drugs (7).

To report SUSPECTED ADVERSE REACTIONS, contact Dermira at1-877-337-5553 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

-----------------------USE IN SPECIFIC POPULATIONS------------------------

• Pediatric use: Safety and efficacy are not established in patientsunder 9 years of age (8.4).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 06/2018

-------------------------------------------------------------

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION