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, not adequately controlled with other anti-asthmatic medicines called corticosteroids and "short-acting beta2 agonists", taken by inhalation, when 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 exacerbations of the disease despite having undergone regular therapy. COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty 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 provides 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 fluticasone furoate and 22 micrograms vilanterol) it can be used exclusively for the treatment of asthma. The recommended dose is one inhalation per day. In the treatment of asthma, therapy may begin with Relvar Ellipta 92/22 micrograms or Relvar Ellipta 184/22 micrograms, depending on previous therapy. If the treatment starts with the lowest dose, the highest dose can be used if the asthma is not adequately controlled. For more information, see the package leaflet.
How does Relvar Ellipta - fluticasone furoate and vilanterol work?
Relvar Ellipta contains two active ingredients. Fluticasone furoate belongs to a group of anti-inflammatory medicines known as corticosteroids. It acts in a manner similar to natural corticosteroid hormones: by binding to receptors on different types of immune cells, it reduces the activity of the immune system. This in turn leads to a decrease in the release of substances involved in the inflammatory process (including histamine) which helps to keep the airways free, allowing the patient to breathe more easily. Vilanterol is a long-acting beta2 agonist. It works by binding to beta2 receptors in the muscle cells of numerous organs. Once inhaled, vilanterol reaches the receptors in the airways and activates them. In this way it induces the relaxation of the airway muscles and helps to keep the airways free, 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 has been 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 as monotherapy, or with placebo (a substance with no effect on the body). The main measure of effectiveness was the improvement in forced expiratory volume (FEV1, the maximum volume of air that a person is able to exhale in one second). After 12 weeks of treatment, Relvar Ellipta 92/22 micrograms improved FEV1 on average by 36 ml more than fluticasone furoate and 172 ml more than placebo. Used at a dose of 184/22 micrograms, after 24 weeks of treatment, it improved FEV1 by 193 ml more than fluticasone furoate and 210 ml more than the medicine used for comparison, fluticasone propionate. The third study compared Relvar Ellipta 92/22 micrograms with fluticasone furoate given as monotherapy. The main measure of effectiveness was the length of time spent without a severe exacerbation of symptoms in patients. Data from this study showed that 12.8% of patients treated with Relvar Ellipta had one or more severe exacerbations over 52 weeks compared to 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, administered separately, and placebo. The main efficacy indicator was FEV1 after 24 weeks of treatment. The first study showed that Relvar Ellipta 92/22 micrograms improved on average FEV1 by 115 ml more than placebo, while the second study showed that Relvar Ellipta 184/22 micrograms improved FEV1 by 131 ml on average more than placebo. In two other studies, three different doses of Relvar Ellipta were compared with vilanterol taken as monotherapy; 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 have been shown to be more effective than vilanterol taken as a single agent in reducing the number of BCPO flare-ups. However, there were no improvements in treatment with Relvar Ellipta 184/22 micrograms compared to treatment with Relvar Ellipta 92/22 micrograms. COPD exacerbations were reduced by 13-34% in patients treated with Relvar Ellipta compared to the group treated with vilanterol only.
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 include pneumonia and fractures (which may affect up to 1 in 10 people), which have been reported more frequently in patients with BCPO than in asthmatics. For the full list of all 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 came to the conclusion that Relvar Ellipta (92/22 micrograms and 184/22 micrograms) was 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 corticosteroid-based inhaled medicines and long-acting beta2 agonists. The Committee also concluded that data from the BCPO studies adequately demonstrated that Relvar Ellipta 92/22 micrograms had a clinically relevant effect on the reduction of 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 increase in the incidence of pneumonia was observed in patients with BCPO, which will need to be examined in 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 included in the summary of product characteristics and the 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 examine the risk of pneumonia associated with this medicine compared to other medicines used in the treatment of BCPO and asthma.
Further information on Relvar Ellipta - fluticasone furoate and vilanterol
On 13 November 2013, the European Commission issued a marketing authorization for Relvar Ellipta, valid throughout the European Union. For more information about treatment with Relvar Ellipta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2013.
