In patients 9 years and older

QBREXZA DEMONSTRATED CONSISTENT AND SUSTAINED EFFICACY FOR UP TO 48 WEEKS OF TREATMENT

44-week extension trial design

ARIDO was a 44-week, long-term safety extension study of QBREXZA in patients
aged ≥9 years with primary axillary hyperhidrosis1,2

  • The primary objective was to evaluate treatment-emergent adverse events (TEAEs) and local skin reactions
    from Week 4 through Week 48
  • Efficacy and safety were evaluated at Week 48, and were consistent with pivotal trials

Endpoints assessed at Week 44 (up to 48 weeks of treatment with QBREXZA)1:

  • Safety analyses
  • Absolute change in axillary sweat production measured gravimetrically

*The sponsor terminated ARIDO early, per protocol, once the study objective was met (100 patients treated for ≥12 months; n=106 [18.8%]). 40%
(226) of patients completed 44 weeks of treatment with QBREXZA in ARIDO. A total of 114 subjects received QBREXZA for ≥48 weeks.3

Safety was evaluated via TEAEs through Week 45 (Week 44 + 1 week safety follow-up) and LSRs up to Week 44.1
LSRs = local skin reactions; TEAEs = treatment-emergent adverse events.

Sustained efficacy at 4 and 44 weeks
IMPORTANT SAFETY INFORMATION

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.

  • 564 patients were treated with QBREXZA for up to an additional 44 weeks after completing 4 weeks of ATMOS-1 and ATMOS-21
  • 40% (226) of patients completed 44 weeks of QBREXZA treatment in ARIDO1
  • A total of 114 subjects received QBREXZA for ≥48 weeks3

‡ARIDO 44 weeks/end of trial: last observation carried forward. Baseline values in ARIDO are from ATMOS-1 and ATMOS-2. Patients who used QBREXZA in ATMOS-1 or ATMOS-2 used QBREXZA for up to 48 weeks; patients who used alcohol-based vehicle in ATMOS-1 or ATMOS-2 used QBREXZA for up to 44 weeks.3

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS (continued)
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.

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References:

  1. Glaser DA, Hebert AA, Nast A, et al. Open-label study evaluating long-term safety of topical glycopyrronium tosylate (GT) in
    patients with primary axillary hyperhidrosis (ARIDO). Poster presented at the 76th Annual Meeting of the American Academy of
    Dermatology; San Diego, California; February 16‑20, 2018.
  2. QBREXZA™ (glycopyrronium) cloth prescribing information, Dermira.
  3. 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.