pharmacopeia
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/api/v1/drug/glycopyrronium

Mechanism of action

Sourced from openFDA

Glycopyrronium is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. In hyperhidrosis, glycopyrronium inhibits the action of acetylcholine on sweat glands, reducing sweating.

CholinergicCholinergic Muscarinic

Indications

Sourced from openFDA
  • 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

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  • 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 ).contraindicated

Dosage & administration

Sourced from openFDA

For topical use only. Qbrexza is for topical use in the underarm area only and not for use in other body areas. Qbrexza is administered by a single-use pre-moistened cloth packaged in individual pouches. Qbrexza should be applied to clean dry skin on the underarm areas only. Qbrexza should not be used more frequently than once every 24 hours. Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply Qbrexza to both underarms. After applying Qbrexza, discard the cloth in the household trash out of reach of children and others. Wash hands immediately with soap and water after applying and discarding the Qbrexza cloth. Qbrexza may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of Qbrexza to the periocular area [see Warnings and Precautions ( 5.3 )] . Do not apply Qbrexza to broken skin. Avoid using Qbrexza with occlusive dressings. For topical use only. Apply Qbrexza once daily to both axillae using a single cloth ( 2 ).

Warnings & precautions

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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 ). 5.1 New 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. 5.3 Operating Machinery or an Automobile Transient blurred vision may occur with use of Qbrexza.

Adverse reactions

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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. 6.1 Clinical 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.

Use in specific populations

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Pediatric use: Safety and efficacy are not established in patients under 9 years of age ( 8.4 ). 8.1 Pregnancy 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.

Pharmacokinetics

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Metabolism
Absorption The pharmacokinetics of glycopyrronium were evaluated in adult and pediatric patients with primary axillary hyperhidrosis following Qbrexza once daily applied to the axillae for 5 days. The mean ± SD exposures of glycopyrronium are presented in Tables 3 and 4.

Overdosage

Sourced from openFDA

Because glycopyrronium is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrronium overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. Associated signs and symptoms related to excessive anticholinergic activity may include flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation and light sensitivity due to mydriasis. In the case of overdose when symptoms are severe or life threatening, therapy may include: Managing per standard of care any acute conditions such as hyperthermia, coma, and/or seizures, as applicable, and managing any myoclonic or choreoathetoid movements which may lead to rhabdomyolysis in some cases of anticholinergic overdosage Managing severe urinary retention with catheterization if not spontaneously reversed within several hours Providing cardiovascular support and/or controlling arrhythmias Maintaining an open airway, providing ventilation as necessary Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate severe and/or life threatening peripheral anticholinergic effects.

Approval history

Sourced from openFDA
  • Jun 28, 2018NDANDA210361Journey

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,500 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Mydriasis27118%
  2. 2Dry Mouth23616%
  3. 3Off Label Use19313%
  4. 4Vision Blurred18312%
  5. 5Intentional Product Misuse946.3%
  6. 6Drug Ineffective936.2%
  7. 7Urinary Retention855.7%
  8. 8Headache835.5%
  9. 9Constipation674.5%
  10. 10Dyspnoea674.5%
  11. 11Pneumonia553.7%
  12. 12Wrong Technique In Product Usage Process543.6%
  13. 13Nausea533.5%
  14. 14Hyperhidrosis513.4%
  15. 15Drug Interaction503.3%

Literature

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Recent PubMed references pinned to Glycopyrronium as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 199 ClinicalTrials.gov registrations naming Glycopyrronium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Glycopyrronium work?
Glycopyrronium is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. In hyperhidrosis, glycopyrronium inhibits the action of acetylcholine on sweat glands, reducing sweating.
What is Glycopyrronium used for?
According to FDA labeling, Glycopyrronium carries indications including: 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 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Glycopyrronium?
Glycopyrronium is classified as Antihidrotics, Anticholinergic, Cholinergic Muscarinic Antagonist, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists, Decreased Acetylcholine Activity.
What are the brand names for Glycopyrronium?
Glycopyrronium is marketed under brand names including Bevespi, Breztri, Cuvposa, Dartisla, Glycate, Glyrx, Lonhala, Prevduo.
What are the contraindications for Glycopyrronium?
Glycopyrronium labeling lists contraindications including: 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 ).. Always consult the full prescribing information and a clinician.
Note. Data for glycopyrronium is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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