The most common side effects include worsening of asthma and nasopharyngitis (inflammation in the nose and throat).[5] Other common side effects include upper respiratory tract infection (nose and throat infections) and headache.[5]
It is the first asthma triple-combination therapy; it consists of a fixed-dose combination of three active substances (indacaterol, glycopyrronium bromide and mometasone furoate) in capsules, to be administered using an inhaler.[7] An optional electronic sensor may also be co-packed with the product.[7] The sensor will be attached to the base of the inhaler to collect data on the use of the inhaler by the patient.[7] The sensor will send the data to an app on a smart phone or other suitable device.[7] It was approved for medical use in the European Union in July 2020.[5][6][8]
Indacaterol/glycopyrronium bromide/mometasone is indicated as a maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.[5]
Indacaterol is a long-acting beta-2 adrenergic receptor agonist.[5] It relaxes the muscle around the airways into the lungs by activating targets called beta-2 receptors in the muscle cells.[5] This helps to keep the airways open.[5]
Glycopyrronium bromide is a muscarinic receptor antagonist.[5] It blocks muscarinic receptors in muscle cells in the airways.[5] Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open.[5]
Mometasone is a corticosteroid that has anti-inflammatory effects.[5] It works in a similar way to corticosteroid hormones in the body, reducing the activity of the immune system (the body's defences).[5] Mometasone helps to keep the airways clear by blocking the release of substances, such as histamine, that are involved in inflammation and release of mucus in the airways.[5]
History
In April 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting a marketing authorization in the European Union for Enerzair Breezhaler, a new asthma treatment which includes an optional digital sensor.[7][9] The CHMP also recommended granting a marketing authorization in the European Union for Zimbus Breezhaler which is a duplicate of Enerzair Breezhaler.[7][10]
Enerzair Breezhaler and Zimbus Breezhaler were approved for medical use in the European Union in July 2020.[5][6][8]
^ ab"Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU". Novartis (Press release). 7 July 2020. Retrieved 21 July 2020.
^"Novartis receives CHMP positive opinion for Enerzair Breezhaler (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma". Novartis (Press release). 1 May 2020. Retrieved 21 July 2020.
^"Zimbus Breezhaler: Pending EC decision". European Medicines Agency (EMA). 30 April 2020. Retrieved 21 July 2020.
External links
"Indacaterol". Drug Information Portal. U.S. National Library of Medicine.
"Glycopyrronium bromide". Drug Information Portal. U.S. National Library of Medicine.
"Mometasone furoate". Drug Information Portal. U.S. National Library of Medicine.
indacaterol, glycopyrronium, bromide, mometasone, sold, under, brand, name, enerzair, breezhaler, among, others, inhalable, fixed, dose, combination, medication, treatment, asthma, contains, indacaterol, acetate, glycopyrronium, bromide, mometasone, furoate, c. Indacaterol glycopyrronium bromide mometasone sold under the brand name Enerzair Breezhaler among others is an inhalable fixed dose combination medication for the treatment of asthma 5 It contains indacaterol as acetate glycopyrronium bromide and mometasone furoate 5 Indacaterol glycopyrronium bromide mometasoneCombination ofIndacaterolUltra long acting beta adrenoceptor agonistGlycopyrronium bromideMuscarinic anticholinergicMometasone furoateCorticosteroidClinical dataTrade namesEnerzair Breezhaler Zimbus BreezhalerOther namesQVM149License dataEU EMA by INNPregnancycategoryAU B3 1 Routes ofadministrationInhalationATC codeR03AL12 WHO Legal statusLegal statusAU S4 Prescription only 2 CA only 3 UK POM Prescription only 4 EU Rx only 5 6 IdentifiersCAS Number2561489 46 9KEGGD11861The most common side effects include worsening of asthma and nasopharyngitis inflammation in the nose and throat 5 Other common side effects include upper respiratory tract infection nose and throat infections and headache 5 It is the first asthma triple combination therapy it consists of a fixed dose combination of three active substances indacaterol glycopyrronium bromide and mometasone furoate in capsules to be administered using an inhaler 7 An optional electronic sensor may also be co packed with the product 7 The sensor will be attached to the base of the inhaler to collect data on the use of the inhaler by the patient 7 The sensor will send the data to an app on a smart phone or other suitable device 7 It was approved for medical use in the European Union in July 2020 5 6 8 Contents 1 Medical uses 2 History 3 References 4 External linksMedical uses EditIndacaterol glycopyrronium bromide mometasone is indicated as a maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year 5 Indacaterol is a long acting beta 2 adrenergic receptor agonist 5 It relaxes the muscle around the airways into the lungs by activating targets called beta 2 receptors in the muscle cells 5 This helps to keep the airways open 5 Glycopyrronium bromide is a muscarinic receptor antagonist 5 It blocks muscarinic receptors in muscle cells in the airways 5 Because these receptors help control the contraction of the airway muscles blocking them causes the muscles to relax helping to keep the airways open 5 Mometasone is a corticosteroid that has anti inflammatory effects 5 It works in a similar way to corticosteroid hormones in the body reducing the activity of the immune system the body s defences 5 Mometasone helps to keep the airways clear by blocking the release of substances such as histamine that are involved in inflammation and release of mucus in the airways 5 History EditIn April 2020 the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency EMA recommended granting a marketing authorization in the European Union for Enerzair Breezhaler a new asthma treatment which includes an optional digital sensor 7 9 The CHMP also recommended granting a marketing authorization in the European Union for Zimbus Breezhaler which is a duplicate of Enerzair Breezhaler 7 10 Enerzair Breezhaler and Zimbus Breezhaler were approved for medical use in the European Union in July 2020 5 6 8 References Edit https www tga gov au sites default files auspar indacaterol acetate glycopyrronium bromide mometasone furoate 210406 pdf bare URL PDF TGA eBS Product and Consumer Medicine Information Licence Regulatory Decision Summary Enerzair Breezhaler Health Canada 23 October 2014 Retrieved 7 June 2022 Enerzair Breezhaler Summary of Product Characteristics SmPC emc 12 May 2021 Retrieved 12 June 2021 a b c d e f g h i j k l m n o p q Enerzair Breezhaler EPAR European Medicines Agency EMA 28 April 2020 Retrieved 21 July 2020 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged a b c Zimbus Breezhaler EPAR European Medicines Agency EMA 28 April 2020 Retrieved 2 September 2020 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged a b c d e f First triple combination therapy for asthma with optional electronic sensor European Medicines Agency EMA 30 April 2020 Retrieved 21 July 2020 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged a b Novartis receives EC approval for Enerzair Breezhaler including the first digital companion sensor and app that can be prescribed alongside a treatment for uncontrolled asthma in the EU Novartis Press release 7 July 2020 Retrieved 21 July 2020 Novartis receives CHMP positive opinion for Enerzair Breezhaler QVM149 a potential first in class inhaled LABA LAMA ICS combination for uncontrolled asthma Novartis Press release 1 May 2020 Retrieved 21 July 2020 Zimbus Breezhaler Pending EC decision European Medicines Agency EMA 30 April 2020 Retrieved 21 July 2020 External links Edit Indacaterol Drug Information Portal U S National Library of Medicine Glycopyrronium bromide Drug Information Portal U S National Library of Medicine Mometasone furoate Drug Information Portal U S National Library of Medicine Portal Medicine Retrieved from https en wikipedia org w index php title Indacaterol glycopyrronium bromide mometasone amp oldid 1091908454, wikipedia, wiki, book, books, library,
