Relvar Ellipta
Authorised
This medicine is authorised for use in the European Union
fluticasone furoate / vilanterol
MedicineHumanAuthorised
Overview
Relvar Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD).
In asthma, it is used for regular treatment of patients from 12 years of age:
- whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting beta-2 agonist;
- whose symptoms are adequately controlled with both inhaled corticosteroids and a long-acting beta-2 agonist.
In COPD, it is used in adults who have flare-ups of the disease despite regular bronchodilator treatment (treatment to widen the airways).
Relvar Ellipta contains the active substances fluticasone furoate and vilanterol.
Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms). The doctor will decide which inhaler the patient should use. The dose is one inhalation (‘puff’) into the mouth once a day at the same time each day.
Relvar Ellipta can only be obtained with a prescription. For more information about using Relvar Ellipta, see the package leaflet or contact your doctor or pharmacist.
Relvar Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.
Fluticasone furoate is a corticosteroid. It works on various types of immune cells, blocking the release of substances involved in inflammation. This reduces inflammation in the airways and improves the patient’s breathing.
Vilanterol is a long-acting beta-2 agonist. It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.
Asthma
Three studies in over 3,200 patients showed that Relvar Ellipta improves breathing and reduces flare-ups in patients with asthma.
In two of the studies, Relvar Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment). Relvar Ellipta 184/22 also improved FEV1 by193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
In a third study, fewer patients taking Relvar Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
A fourth study in 1,522 patients showed that Relvar Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol). These patients were already well controlled with the comparator medicine and Relvar Ellipta treatment was able to maintain their FEV1.
COPD
Four studies in over 5,500 patients showed that Relvar Ellipta improves breathing and reduces flare-ups of symptoms in patients with COPD.
The first study showed that Relvar Ellipta 92/22 improved average FEV1 by 115 ml more than placebo, and a second study showed that Relvar Ellipta 184/22 improved average FEV1 by 131 ml more than placebo.
In two further studies, Relvar Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone.
The most common side effects with Relvar Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat). More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma. For the full list of side effects of Relvar Ellipta, see the package leaflet.
Relvar Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD. Regarding its safety, the most frequent side effects reported with Relvar Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
The European Medicines Agency concluded that Relvar Ellipta’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 Relvar Ellipta have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Relvar Ellipta are continuously monitored. Side effects reported with Relvar Ellipta are carefully evaluated and any necessary action taken to protect patients.
Relvar Ellipta received a marketing authorisation valid throughout the EU on 13 November 2013.
Product information
Latest procedure affecting product information: WS2438/G
06/07/2023
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
- Relvar Ellipta
- Active substance
- fluticasone furoate
- vilanterol
- International non-proprietary name (INN) or common name
- fluticasone furoate
- vilanterol
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03AK10
Pharmacotherapeutic group
Adrenergics and other drugs for obstructive airway diseasesTherapeutic indication
Asthma indication:
Relvar Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists.
- patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.
COPD indication:
Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.
Assessment history
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