In patients 9 to 16 years

QBREXZA DEMONSTRATED EFFICACY IN PEDIATRIC PATIENTS ACROSS TWO PHASE 3 TRIALS1

Coprimary endpoint 1: sweat severity (ASDD-C Item 2)
ASDD-C Item 2 responder rate (≥4-point improvement, on an 11-point scale) at Week 4 (patient-reported outcome)1
60% of pediatric patients using QBREXZA (n=25) reported a ≥4-point reduction in sweat severity score on an 11-point scale at Week 4 vs 13% with alcohol-based vehicle (n=19).
60% of patients using QBREXZA (n=463) reported a ≥4-point reduction in sweat severity score on an 11-point scale at Week 4 vs 28% with alcohol-based vehicle (n=234).
IMPORTANT SAFETY INFORMATION (continued)

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).

A novel validated patient-reported outcome tool developed in consultation with the FDA to measure sweat severity.2

Axillary sweating daily diary
(ASDD/ASDD-C [child-specific])2

About ASDD

  • ASDD was used to assess sweat severity
  • ASDD Item 2 was developed in consultation with the FDA and the 2009 FDA guidance on patient-reported outcomes
  • ASDD-C was developed for patients younger than 16

How ASDD Item 2 was measured

Patients were first asked whether they had experienced any underarm sweating in the last 24 hours

  • Patients who answered "Yes" were then asked to rate that sweat:
    • ASDD: During the past 24 hours, how would you rate your underarm sweating at its worst?
    • ASDD-C: Thinking about last night and today, how bad was your underarm sweating?
  • Results reported as the proportion of patients with ≥4-point improvement in sweating severity from baseline on an 11-point scale from 10 (worst possible sweating) to 0 (no sweating at all)
Coprimary endpoint 2: sweat production (measured gravimetrically)
In ATMOS-1 and ATMOS-2 pooled sweat production in patients 9-16 years old reported a 75% median change from baseline to Week 4 with Qbrexza (n-25) vs 55% with alcohol-based vehicle (n=19).
In ATMOS-1 and ATMOS-2 pooled sweat production in patients 9-16 years old reported a 75% median change from baseline to Week 4 with Qbrexza (n-25) vs 55% with alcohol-based vehicle (n=19).
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS

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.

The absolute change in axillary sweat production measured gravimetrically was a
coprimary endpoint for ATMOS-1 and ATMOS-23,4

  • Sweat production was measured per mg/5 min in each axilla
  • Two gauze pads were applied to dried axillary surface for 5 minutes
  • Gauze was removed and weighed to quantify sweat production

References:

  1. Hebert AA, Glaser DA, Green L, et al. Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials. Pediatr Dermatol. 2019;36:89-99.
  2. Glaser DA, Hebert AA, Nast A, et al. Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2019;80(1):128-138.
  3. QBREXZA™ (glycopyrronium) cloth prescribing information, Dermira.
  4. Data on file. Dermira, Inc. Menlo Park, CA.
INDICATION

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

IMPORTANT SAFETY INFORMATION

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).

WARNINGS AND PRECAUTIONS

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.

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.

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.

ADVERSE REACTIONS

The most common adverse reactions seen in ≥2% of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat (2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.

DRUG INTERACTIONS

Anticholinergics: 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.

INSTRUCTIONS FOR ADMINISTERING QBREXZA

Instruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one 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 if it comes in contact with the eyes.

Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.

Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.

Please see Full Prescribing Information.