Qbrexza (glycopyrronium tosylate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Glycopyrronium tosylate is a quaternary ammonium topical anticholinergic agent.
Glycopyrronium tosylate, a quaternary ammonium anticholinergic agent, competitively inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves, including sweat glands. While the exact cause has not been fully established, primary hyperhidrosis is thought to result from autonomic nervous system dysregulation leading to the overstimulation of cholinergic receptors on the eccrine sweat glands. By inhibiting the action of acetylcholine on sweat glands, glycopyrronium reduces the rate of sweat secretion.
Following topical application of cloths premoistened with glycopyrronium 2.4% solution to the axillae once daily for 5 days, pharmacokinetic parameters of the drug are similar in adults and pediatric patients 10-17 years of age; peak plasma concentrations average 0.07-0.08 ng/mL and are attained at a median of 1 hour after application in adults and 1.5 hours in pediatric patients. There is no evidence of drug accumulation. By comparison, mean plasma concentrations of the drug in adults receiving an oral glycopyrrolate solution (initial dosage of 1 mg every 8 hours, increased in 1-mg increments every 5 days to a maximum dosage of 3 mg every 8 hours) ranged from 0.15-0.38 ng/mL.
Following IV administration of glycopyrronium in adults who had undergone surgery for cholelithiasis, about 85% of the dose was excreted in urine and less than 5% was distributed into bile; more than 80% of the drug present in urine or bile was unchanged drug.
USES: This form of glycopyrronium is used to treat excessive sweating from your underarms. The drug solution is on a pre-moistened cloth for application to the skin. It works on the sweat glands to reduce sweating.
Glycopyrronium belongs to a class of drugs known as anticholinergics.
Generic name: glycopyrronium tosylate
Pronunciation: (GLYE-koe-pir-OH-nee-um)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Qbrexza
Indications
The following indications are listed for Qbrexza:
- Primary Focal Hyperhidrosis Of Axilla
Also known as: Primary Axillary Hyperhidrosis.
Dosing
Concentration of glycopyrronium tosylate is expressed in terms of glycopyrronium.
For the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older, one cloth premoistened with glycopyrronium 2.4% solution should be wiped once across both axillae once daily. Glycopyrronium topical solution should not be applied more frequently than once every 24 hours.
Glycopyrronium tosylate is applied topically using an absorbent polypropylene pad (cloth) that has been premoistened with a solution containing 2.4% glycopyrronium. The solution is for topical external use only and should be applied to clean, dry skin in the axillary area only. The solution should not be applied to other body areas or to broken skin; treated sites should not be covered by occlusive dressings.
Because glycopyrronium may cause temporary mydriasis and blurred vision if contact with the eyes occurs, care should be taken to avoid transfer of the solution to the periocular area.
Prior to topical application, a pouch containing a single cloth premoistened with glycopyrronium 2.4% solution should be torn open, and the cloth should be pulled out, unfolded, and wiped once across one entire axilla and then across the other axilla. The cloth should then be discarded and the hands should be washed immediately with soap and water. The cloths should not be reused.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Medical conditions that can be 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, Sjogren's syndrome).
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects occurring in 2% or more of patients receiving glycopyrronium 2.4% topical solution include dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, blurred vision, nasal dryness, dry throat, dry eye, dry skin, and constipation. Adverse local effects (e.g., erythema, burning/stinging, pruritus) have been reported in more than 5% of patients receiving the drug.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of glycopyrronium topical solution have not been established in pediatric patients younger than 9 years of age. Safety, efficacy, and pharmacokinetics of the drug have been established in pediatric patients 9 years of age and older for the topical treatment of primary axillary hyperhidrosis. Use in this age group is supported by evidence from 2 clinical trials that included 34 pediatric patients 9 years of age or older. (See Primary Axillary Hyperhidrosis under Uses.)
No data are available regarding topical use of glycopyrronium in pregnant women by which to establish a drug-associated risk for adverse developmental outcomes. No adverse embryofetal developmental effects were observed with IV glycopyrrolate (glycopyrronium bromide) in rabbits. No increase in the incidence of gross external or visceral defects was observed with oral glycopyrrolate in rats, although reduced maternal and fetal weight gain, fetal resorption, and minor skeletal effects (likely secondary to maternal toxicity) were observed. 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.
It is not known whether topically administered glycopyrronium or its metabolites are distributed into milk, affect breast-fed infants, or affect milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for topical glycopyrronium and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
There is insufficient experience in patients 65 years of age and older to determine whether geriatric patients respond differently than younger individuals.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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