Antihidrotics

Qbrexza

Approved 28 Jun 2018TopicalCloth

Indications

Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 ).

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). 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

New or worsening urinary retention: Use with caution in patients with a history 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 ).

5.1New or Worsening Urinary Retention New

or worsening signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder) have occurred in patients taking Qbrexza with or without a history of documented urinary retention. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Qbrexza should be used with caution in patients with prostatic hypertrophy or bladder-neck obstruction.

5.2 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.

At a glance

Brand name: Qbrexza
Active substance: glycopyrronium tosylate
Drug class: Antihidrotics
Route: Topical
Dosage form: Cloth
Applicant: Journey
Status: Prescription
FDA approval: 28 Jun 2018
Application: NDA210361-001
RxCUI: 2054111

Contraindications

Warnings and precautions

If blurred vision occurs, discontinue use of Qbrexza until symptoms resolve; avoid operating a motor vehicle or other machinery until symptoms resolve ( 5.3 ).

5.1New or Worsening Urinary Retention New

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on Qbrexza use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In pregnant rats, daily oral administration of glycopyrrolate (glycopyrronium bromide) during organogenesis did not result in an increased incidence of gross external or visceral defects [see Data ] . When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis, no adverse effects on embryo-fetal development were seen.

The available data do not support relevant comparisons of systemic glycopyrronium exposures achieved in the animal studies to exposures observed in humans after topical use of Qbrexza. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Glycopyrrolate was orally administered to pregnant rats at dosages of 50, 200, and 400 mg/kg/day during the period of organogenesis. Glycopyrrolate had no effect on maternal survival, but significantly reduced mean maternal body weight gain over the period of dosing at all dosages evaluated. Mean fetal weight was significantly reduced in the 200 and 400 mg/kg/day dose groups. There were two litters with all resorbed fetuses in the 400 mg/kg/day dose group.

There were no effects of treatment on the incidence of gross external or visceral defects. Minor treatment-related skeletal effects included reduced ossification of various bones in the 200 and 400 mg/kg/day dose groups; these skeletal effects were likely secondary to maternal toxicity. Glycopyrrolate was intravenously administered to pregnant rabbits at dosages of 0.1, 0.5, and 1.0 mg/kg/day during the period of organogenesis.

Glycopyrrolate did not affect maternal survival under the conditions of this study. Mean maternal body weight gain and mean food consumption over the period of dosing were lower than the corresponding control value in the 0.5 and 1.0 mg/kg/day treatment groups. There were no effects of treatment on fetal parameters, including fetal survival, mean fetal weight, and the incidence of external, visceral, or skeletal defects.

Female rats that were pregnant or nursing were orally dosed with glycopyrrolate daily at dosages of 0, 50, 200, or 400 mg/kg/day, beginning on day 7 of gestation, and continuing until day 20 of lactation. Mean body weight of pups in all treatment groups was reduced compared to the control group during the period of nursing, but eventually recovered to be comparable to the control group, post-weaning. No other notable delivery or litter parameters were affected by treatment in any group, including no effects on mean duration of gestation or mean numbers of live pups per litter.

No treatment-related effects on survival or adverse clinical signs were observed in pups. There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups.

Adverse reactions

The following adverse reactions are described in greater detail in other sections

New or Worsening Urinary Retention [see Warnings and Precautions ( 5.1 )] 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 Journey Medical Corp. at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02530281] and Trial 2 [NCT02530294]) of 459 subjects treated with Qbrexza once daily and 232 treated with vehicle, subjects were 9 to 76 years of age, 47% male, and the percentages of White, Black (including African Americans), and Asian subjects were 82%, 12%, and 1%, respectively.

Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with Qbrexza. Table 1: Adverse Reactions Occurring in ≥2% of Subjects Adverse Reactions Qbrexza (N=459) n (%) Vehicle (N=232) n (%) Dry mouth 111 (24.2%) 13 (5.6%) Mydriasis 31 (6.8%) 0 Oropharyngeal pain 26 (5.7%) 3 (1.3%) Headache 23 (5.0%) 5 (2.2%) Urinary hesitation 16 (3.5%) 0 Vision blurred 16 (3.5%) 0 Nasal dryness 12 (2.6%) 1 (0.4%) Dry throat 12 (2.6%) 0 Dry eye 11 (2.4%) 1 (0.4%) Dry skin 10 (2.2%) 0 Constipation 9 (2.0%) 0 Table 2 shows the most frequently reported local skin reactions, which were relatively common in both the Qbrexza and vehicle groups.

Table 2: Local Skin Reactions a Patients with a post-baseline local skin reaction assessment Local Skin Reactions Qbrexza (N=454) a n (%) Vehicle (N=231) a n (%) Erythema 77 (17.0%) 39 (16.9%) Burning/stinging 64 (14.1%) 39 (16.9%) Pruritus 37 (8.1%) 14 (6.1%) In an open-label safety trial (NCT02553798), 564 subjects were treated for up to an additional 44 weeks after completing Trial 1 or Trial 2. Adverse reactions occurring at a frequency ≥2.0% were: dry mouth (16.9%), vision blurred (6.7%), nasopharyngitis (5.8%), mydriasis (5.3%), urinary hesitation (4.2%), nasal dryness (3.6%), dry eye (2.9%), pharyngitis (2.2%), and application site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema [2.4%]).

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Qbrexza. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Qbrexza exposure.

Genitourinary system disorders : new onset urinary retention [ see Warnings and Precautions ( 5.1 ) ]

Qbrexza

Indications

Contraindications

Warnings and precautions

5.1New or Worsening Urinary Retention New

At a glance

Two medicines in one question?

Qbrexza

Indications

Contraindications

Warnings and precautions

5.1New or Worsening Urinary Retention New

At a glance

Two medicines in one question?

5.3Operating Machinery or an Automobile

5.4Risk of Accidental Exposure Cases

Interactions

7.1Anticholinergics Coadministration of Qbrexza

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information