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Glycopyrronium

Published
Topics: Anaesthesia and painCCG commissioned new medicinesGlycopyrronium · Neurological disordersNew MedicinesPatent expiriesRespiratory disordersSafety in BreastfeedingSkin disorders ·
Contents
  1. dm+d
  2. Articles
  3. Lactation Safety Information
    1. For premedication and bradycardia
    2. Glycopyrrolate as an antiperspirant and in iontophoresis
    3. Inhalation · as a bronchodilator
  4. New Medicines
    1. Qbrexza · Hyperhidrosis - primary axillary in patients aged 9 years and older in the form of a solution applied via disposable cloths (wipes).

dm+d

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Articles

What injections can be given orally or via enteral feeding tubes?

6 November 2020This updated Medicines Q&A is a quick reference summary to different types of enteral feeding tubes, in relation to medication issues. Not all enteral feeding…

Safety in Lactation: Antimuscarinic drugs

5 November 2020These antimuscarinics are used as premedication, to dry secretions, and for intraoperative bradycardia. They are given as a single dose by injection, repeated if necessary…

Safety in Lactation: Drugs for obstructive airways disease

25 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Bronchodilators Most bronchodilators are considered to…

Hypersalivation – what drug treatment options are available?

1 August 2018This Medicines Q&A is one of a series of five Q&A documents to address the drug treatment of hypersalivation (drooling or sialorrhoea). It gives a…

Hypersalivation – can glycopyrronium be used to treat it?

1 August 2018This Medicines Q&A evaluates the available evidence for the use of glycopyrronium (glycopyrrolate) for the management of non drug-induced hypersalivation (drooling or sialorrhoea). Update November…
Search Articles

Lactation Safety Information

For premedication and bradycardia

For premedication and bradycardia
Yes
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
Safety in Lactation: Antimuscarinic drugs
22 September 2020
LactMed

Glycopyrrolate as an antiperspirant and in iontophoresis

Glycopyrrolate as an antiperspirant and in iontophoresis
Yes
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
22 September 2020
LactMed

Inhalation as a bronchodilator

Inhalation
as a bronchodilator
Yes
-
Synonym: glycopyrrolate
Antimuscarinic bronchodilator
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties
Safety in Lactation: Drugs for obstructive airways disease
22 September 2020
Bibliography

New Medicines

QbrexzaHyperhidrosis - primary axillary in patients aged 9 years and older in the form of a solution applied via disposable cloths (wipes).

Information

Qbrexza
New formulation
Eli Lilly
Dermira

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Feb 20: Eli Lilly has acquired Dermira [13].

Dec 19: UK and European launch unclear; 2018 form 10-k states "We may also partner with third parties to help us reach other geographic markets or therapeutic specialties" [12].

Sep 18: Launched the US for the treatment of primary axillary hyperhidrosis in adults and paediatric patients aged 9 years and older [11].

Jul 18: Launch of Qbrexza in the US planned for October 2018 and Dermira are looking at additional indications, e.g. hyperhidrosis of hands, feet and face [10].

Jun 18: FDA approves Qbrexza for topical treatment of primary axillary hyperhidrosis [8].

Nov 17: Dermira announced that the FDA has accepted the NDA for topical glycopyrrolate for the treatment of primary axillary hyperhidrosis. They intend to market it in the second half of 2018 [7].

Jun 16: Dermira plans to submit an NDA to the FDA for approval of DRM04 in H2 2017, subject to it completing the PIII ARIDO trial, an open-label trial assessing the long-term safety of DRM04 [1].

Category

A tosylate salt of glycopyrrolate, designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation [4,5]
The prevalence of hyperhidrosis is estimated as being about 1% of the population but the true prevalence is unknown, mainly because many affected people are not seen for treatment. Hyperhidrosis occurs both in children and adults, with the average age of onset of primary hyperhidrosis being 14-25 years [2].
Hyperhidrosis - primary axillary in patients aged 9 years and older in the form of a solution applied via disposable cloths (wipes).
Topical

Evidence based evaluations

US Prescribing Info