What is Relvar Ellipta and what is it used for - fluticasone furoate and vilanterol?
Relvar Ellipta is a medicine that contains the active substances fluticasone furoate and vilanterol. It is indicated for the regular treatment of asthma in adults and adolescents from 12 years of age who are not adequately controlled with other anti-asthma medicines called corticosteroids and "short-acting" beta2 agonists, taken by inhalation, when the "Use of a combination medicine is considered appropriate. Relvar Ellipta is also indicated to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adult patients with a history of disease flare-ups despite having been on regular therapy. COPD is a disease. chronic in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty in breathing.
How is Relvar Ellipta used - fluticasone furoate and vilanterol?
Relvar Ellipta can only be obtained with a prescription. It is available as an inhalation powder contained in a portable inhaler; each inhalation delivers a fixed dose of medicine. Relvar Ellipta 92/22 micrograms (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) can be used for the treatment of asthma and COPD, while Relvar Ellipta 184/22 micrograms (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol) can only be used for the treatment of asthma. The recommended dose is one inhalation per day. In the treatment of asthma, therapy can be started with Relvar Ellipta 92/22 micrograms or Relvar Ellipta 184/22 micrograms, depending on previous therapy. If treatment is started with the lower dose, the higher dose may be used if asthma is not adequately controlled. For more information, see the package leaflet.
How does Relvar Ellipta work - fluticasone furoate and vilanterol?
Relvar Ellipta contains two active ingredients. Fluticasone furoate belongs to a group of anti-inflammatory medicines known as corticosteroids. It acts in a similar way to natural corticosteroid hormones: by binding to receptors present on different types of immune cells, it reduces the activity of the immune system. This in turn causes a decrease in the release of substances involved in the inflammatory process (including histamine ) which helps keep the airways clear, allowing the patient to breathe more easily. Vilanterol is a long-acting beta2 agonist. It works by binding to beta2 receptors present in the muscle cells of numerous organs. Once inhaled, vilanterol reaches the receptors in the airways and activates them. In this way it induces relaxation of the muscles of the muscles. airways and helps keep the airways clear, allowing the patient to breathe more easily. Corticosteroids and long-acting beta2 agonists are usually used in combination in the treatment of asthma and COPD.
What benefit has Relvar Ellipta - fluticasone furoate and vilanterol shown during the studies?
In the treatment of asthma, Relvar Ellipta was studied in three main studies involving over 3,200 patients. In two studies, Relvar Ellipta was compared with fluticasone furoate or fluticasone propionate, inhaled powder, used alone, or with placebo. (substance with no effects on the organism). The main measure of effectiveness was the improvement in forced expiratory volume (FEV1, the maximum volume of air a person is able to exhale in one second). After 12 weeks of treatment, Relvar Ellipta 92/22 micrograms improved FEV1 on average by 36ml more than fluticasone furoate and 172ml more than placebo. Used at a dose of 184/22 micrograms, after 24 weeks of treatment, it improved FEV1 by 193ml more than fluticasone furoate and 210ml more than the comparator, fluticasone propionate. The third study compared Relvar Ellipta 92/22 micrograms with fluticasone furoate given alone. The main measure of effectiveness was the length of time that patients did not experience a severe flare-up of symptoms. Data from this study showed that 12.8% of patients treated with Relvar Ellipta had one or more severe flare-ups. over 52 weeks compared with 15.9% of patients treated with fluticasone furoate alone. In the treatment of BCPO, 4 main studies were conducted, involving a total of more than 5 500 adults. Two studies compared different doses of Relvar Ellipta with fluticasone furoate and vilanterol, given separately, and placebo. The main measure of effectiveness was FEV1 after 24 weeks of treatment. The first study showed that Relvar Ellipta 92/22 micrograms improved FEV1 on average by 115ml more than placebo, while the second study showed that Relvar Ellipta 184/22 micrograms improved FEV1 on average by 131 ml more than placebo. In two other studies, three different doses of Relvar Ellipta were compared with vilanterol taken alone; the main measure of effectiveness was the reduction in the number. of moderate to severe exacerbations in BCPO patients over 52 weeks (one year) of treatment. All doses of Relvar Ellipta were shown to be more effective than vilanterol taken alone in reducing the number of BCPO exacerbations. However, There was no improvement in treatment with Relvar Ellipta 184/22 micrograms compared to treatment with Relvar Ellipta 92/22 micrograms. COPD ions were reduced by 13-34% in patients treated with Relvar Ellipta compared to the vilanterol alone group.
What is the risk associated with Relvar Ellipta - fluticasone furoate and vilanterol?
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). The most serious side effects included pneumonia and fractures (which may affect up to 1 in 10 people), which have been reported more frequently in BCPO patients than in asthmatics. For the full list of side effects reported with Relvar Ellipta, see the package leaflet.
Why has Relvar Ellipta - fluticasone furoate and vilanterol been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Relvar Ellipta's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Relvar Ellipta ( 92/22 micrograms and 184/22 micrograms) has been shown to be effective in improving FEV1 in asthmatic patients; furthermore, it has been shown to effectively reduce the number of asthma exacerbations. This reduction, although modest, was considered clinically relevant and similar to the effects of other inhaled corticosteroid medicinal products and long-acting beta2 agonists. The Committee also concluded that data from BCPO studies adequately demonstrated that Relvar Ellipta 92/22 micrograms had a clinically relevant effect on reducing COPD exacerbations. Regarding the safety profile of the medicine, the most commonly reported side effects with Relvar Ellipta were similar to those seen with other medicines used in the treatment of BCPO and asthma. An increased incidence of pneumonia was observed in patients with BCPO. which will have to be examined in the context of further studies.
What measures are being taken to ensure the safe and effective use of Relvar Ellipta - fluticasone furoate and vilanterol?
A risk management plan has been developed to ensure that Relvar Ellipta is used as safely as possible.Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Relvar Ellipta, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Relvar Ellipta will conduct further studies to look at the risk of pneumonia associated with this medicine compared with other medicines used in the treatment of BCPO and asthma.
More information about Relvar Ellipta - fluticasone furoate and vilanterol
On November 13, 2013, the European Commission issued a "Marketing Authorization" for Relvar Ellipta, valid throughout the European Union. For more information on Relvar Ellipta therapy, read the package leaflet (included with the EPAR) or consult your doctor or pharmacist. Last update of this summary: 11-2013.
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