Riltrava Aerosphere
Authorised
This medicine is authorised for use in the European Union
formoterol fumarate dihydrate / glycopyrronium / budesonide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Riltrava Aerosphere is a medicine used to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD), a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing.
Riltrava Aerosphere is used for maintenance (regular) treatment in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a long-acting muscarinic antagonist.
Riltrava Aerosphere contains the active substances formoterol, glycopyrronium bromide and budesonide.
This medicine is the same as Trixeo Aerosphere, which is already authorised in the EU. The company that makes Trixeo Aerosphere has agreed that its scientific data can be used for Riltrava Aerosphere (‘informed consent’).
Riltrava Aerosphere can only be obtained with a prescription. It is available in a portable inhaler device. The recommended dose is two inhalations twice a day (two in the morning and two in the evening). Patients should be shown how to use the inhaler correctly by a doctor or other healthcare professional.
For more information about using Riltrava Aerosphere, see the package leaflet or contact your doctor or pharmacist.
Riltrava Aerosphere contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.
Formoterol is a long-acting beta-2 agonist. It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.
Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. This means that it blocks muscarinic receptors in muscle cells in the airways. Because these receptors help control the contraction of muscles, glycopyrronium causes the muscles of the airways to relax, helping to keep the airways open.
Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system (the body’s natural defences) by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby keeping the airways clear and allowing the patient to breathe more easily.
Two main studies in over 10,000 patients with moderate to very severe COPD have shown that Riltrava Aerosphere is effective at improving patients’ FEV1 (the maximum volume of air they can breathe out in one second) and at reducing the number of exacerbations (flare-ups) of the disease.
In the first study, patients treated with Riltrava Aerosphere for 24 weeks had FEV1 increases of around 147 ml, compared with 125 ml for patients treated with glycopyrronium/formoterol, and 73 ml and 88 ml for patients treated with two different inhalers containing budesonide/formoterol.
The second study, which lasted one year, showed that patients treated with Riltrava Aerosphere had fewer COPD exacerbations (1.08 per year) than patients treated with with glycopyrronium/formoterol (1.42) or budesonide/formoterol (1.24).
The most common side effects with Riltrava Aerosphere (which may affect up to 1 in 10 people) are pneumonia (lung infection), headache and urinary tract infection.
For the full list of side effects and restrictions of Riltrava Aerosphere, see the package leaflet.
Riltrava Aerosphere improved lung function in patients with moderate to severe COPD, and reduced disease exacerbations. The safety profile of Riltrava Aerosphere is considered similar to that of medicines containing combinations of a corticosteroid, beta-2 agonist and antimuscarinic. The European Medicines Agency therefore decided that Riltrava Aerosphere’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Riltrava Aerosphere have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Riltrava Aerosphere are continuously monitored. Side effects reported with Riltrava Aerosphere are carefully evaluated and any necessary action taken to protect patients.
Riltrava Aerosphere received a marketing authorisation valid throughout the EU on 6 January 2022.
Product information
Latest procedure affecting product information:
N/0016
05/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Riltrava Aerosphere
- Active substance
- Budesonide
- formoterol fumarate dihydrate
- Glycopyrronium bromide
- International non-proprietary name (INN) or common name
- formoterol fumarate dihydrate
- glycopyrronium
- budesonide
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03AL11
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).
News on Riltrava Aerosphere
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