Introduction

Anticholinergic agent.

Uses for Glycopyrronium

Primary Axillary Hyperhidrosis

Treatment of primary axillary hyperhidrosis.

May be considered for first-line therapy or for use in patients who have had an unsatisfactory response to antiperspirants containing aluminum or zirconium salts. Other second-line treatment options include botulinum toxin injections and microwave thermolysis. An adequate trial of such therapy usually is recommended before systemic oral drug therapy, local sweat gland ablation, or sympathectomy is considered.

Glycopyrronium Dosage and Administration

Administration

Topical Administration

Apply topically using an absorbent polypropylene pad (cloth) that has been premoistened with a solution containing 2.4% glycopyrronium.

For topical external use only. Apply to clean dry skin in the axillary area only. Do not apply to other body areas or to broken skin. Do not cover treated areas with occlusive dressings.

May cause temporary mydriasis and blurred vision if contact with the eyes occurs; take care to avoid transferring solution to the periocular area.

Prior to application, tear open a pouch containing a single cloth premoistened with glycopyrronium 2.4% solution, pull out and unfold the cloth, then wipe it once across one entire axilla and then across the other axilla. Do not reuse the cloth.

Wash hands with soap and water immediately after applying solution and discarding the cloth.

Dosage

Available as glycopyrronium tosylate; concentration expressed in terms of glycopyrronium.

Pediatric Patients

Primary Axillary Hyperhidrosis

Topical

Pediatric patients ≥9 years of age: Wipe one cloth premoistened with glycopyrronium 2.4% solution across both axillae one time once daily.

Adults

Primary Axillary Hyperhidrosis

Topical

Wipe one cloth premoistened with glycopyrronium 2.4% solution across both axillae one time once daily.

Prescribing Limits

Pediatric Patients

Primary Axillary Hyperhidrosis

Topical

Pediatric patients ≥9 years of age: Do not apply more frequently than once every 24 hours.

Adults

Primary Axillary Hyperhidrosis

Topical

Do not apply more frequently than once every 24 hours.

Special Populations

No special population dosage recommendations.

Contraindications

• Medical conditions potentially exacerbated by increased anticholinergic activity (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in patients with acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren’s syndrome).

Warnings/Precautions

GU Disorders

Use with caution in patients with current or prior documented urinary retention. Be alert for manifestations of urinary retention (e.g., difficulty passing urine, distended bladder), especially in individuals with prostatic hyperplasia or bladder neck obstruction, and discontinue use immediately if such manifestations develop. Clinical trials did not include patients with a history of urinary retention.

Thermoregulatory Effects

At hot or very warm environmental temperatures, heat illness (e.g., hyperpyrexia, heat stroke) due to decreased sweating reported with use of anticholinergic drugs. Be alert for a generalized lack of sweating when exposed to such conditions. Advise patients to avoid use if not sweating in hot or very warm temperatures.

Ocular Effects

Transient blurred vision reported following topical application. Performance of activities requiring visual acuity (e.g., operating machinery, driving a motor vehicle, performing hazardous work) may be impaired. If blurred vision occurs, discontinue use until symptoms resolve.

Flammability

Qbrexza cloths premoistened with glycopyrronium tosylate solution are flammable; do not expose to excessive heat or flames.

Specific Populations

Pregnancy

No available data regarding topical glycopyrronium use in pregnant women by which to establish a drug-associated risk for adverse developmental outcomes.

No adverse embryofetal developmental effects observed with IV glycopyrrolate (glycopyrronium bromide) in rabbits. No increase in incidence of gross external or visceral defects observed with oral glycopyrrolate in rats. 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 glycopyrronium 2.4% solution.

Lactation

Not known whether topically administered glycopyrronium or its metabolites distribute into milk, affect breast-fed infants, or affect milk production.

Consider developmental and health benefits of breast-feeding along with the mother's clinical need for topical glycopyrronium and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established in pediatric patients <9 years of age. Use for topical treatment of primary axillary hyperhidrosis in pediatric patients ≥9 years of age supported by evidence from 2 clinical trials that included 34 pediatric patients ≥9 years of age.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger individuals.

Renal Impairment

Elimination of IV glycopyrronium in patients with renal failure is severely impaired. Pharmacokinetics of topical glycopyrronium in patients with renal impairment not determined.

Common Adverse Effects

Topical therapy of primary axillary hyperhidrosis (≥2%): Dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, blurred vision, nasal dryness, dry throat, dry eye, dry skin, constipation. Adverse local effects (e.g., erythema, burning/stinging, pruritus) reported in >5% of patients.

Administration

Topical Administration

Apply topically using an absorbent polypropylene pad (cloth) that has been premoistened with a solution containing 2.4% glycopyrronium.

For topical external use only. Apply to clean dry skin in the axillary area only. Do not apply to other body areas or to broken skin. Do not cover treated areas with occlusive dressings.

May cause temporary mydriasis and blurred vision if contact with the eyes occurs; take care to avoid transferring solution to the periocular area.

Prior to application, tear open a pouch containing a single cloth premoistened with glycopyrronium 2.4% solution, pull out and unfold the cloth, then wipe it once across one entire axilla and then across the other axilla. Do not reuse the cloth.

Wash hands with soap and water immediately after applying solution and discarding the cloth.

Dosage

Available as glycopyrronium tosylate; concentration expressed in terms of glycopyrronium.

Pediatric Patients

Primary Axillary Hyperhidrosis

Topical

Pediatric patients ≥9 years of age: Wipe one cloth premoistened with glycopyrronium 2.4% solution across both axillae one time once daily.

Adults

Primary Axillary Hyperhidrosis

Topical

Wipe one cloth premoistened with glycopyrronium 2.4% solution across both axillae one time once daily.

Prescribing Limits

Pediatric Patients

Primary Axillary Hyperhidrosis

Topical

Pediatric patients ≥9 years of age: Do not apply more frequently than once every 24 hours.

Adults

Primary Axillary Hyperhidrosis

Topical

Do not apply more frequently than once every 24 hours.

Special Populations

No special population dosage recommendations.

Topical glycopyrronium not expected to induce CYP isoenzymes 1A2, 2B6, or 3A4 or inhibit CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4.

Specific Drugs