Aerivio Spiromax - Salmeterol - Fluticasone

What is Aerivio Spiromax - Salmeterol - Fluticasone and what is it used for?

Aerivio Spiromax is a medicine used for the regular treatment of adults with severe asthma and to relieve the symptoms of chronic obstructive pulmonary disease (COPD, a long-lasting disease in which the airways and alveoli of the lungs are progressively damaged or blocked, with resulting in breathing difficulties). Contains the active substances salmeterol (a long-acting beta-2-agonist) and fluticasone propionate (a corticosteroid).

In the treatment of asthma, Aerivio Spiromax can be used in patients whose disease is not adequately controlled by treatment with a combination of a beta-2-agonist and a lower dose of inhaled corticosteroid or in patients whose asthma is already adequately controlled with a long-acting beta-2 agonist and a high dose of inhaled corticosteroid.

In COPD, Aerivio Spiromax is used in adults who have had exacerbations (flare-ups) of the disease in the past and who experience significant symptoms despite regular treatment.

Aerivio Spiromax is a 'hybrid' medicine. This means that it is similar to a 'reference medicine' called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active substances. However, Aerivio Spiromax is only available in a single high strength, while the reference medicine is available in three strengths - the same high strength and two lower strengths. Since Aerivio Spiromax is only available in a single high strength, its use in asthma has been limited to patients whose disease is severe.

How is Aerivio Spiromax - Salmeterol - Fluticasone used?

Aerivio Spiromax is available as an inhalation powder contained in a portable inhaler. A predetermined dose of the medicine is administered with each inhalation.

The recommended dose is one "inhalation twice daily. Patients should be evaluated periodically by a physician to ensure that they are given the lowest dose sufficient to control symptoms. As Aerivio Spiromax is only available with a single high dose (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower dose prove appropriate, patients should switch to an alternative combination of salmeterol and fluticasone propionate containing a lower dose of fluticasone propionate.

Aerivio Spiromax can only be obtained with a prescription. For more information, see the package leaflet

How does Aerivio Spiromax - Salmeterol - Fluticasone work?

The two active substances in Aerivio Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.

Salmeterol is a long-acting beta2 agonist. It works by binding to receptors known as beta2 receptors present in the muscles of the airways. By binding to these receptors, it induces muscle relaxation, which in turn helps keep the airways dilated and promotes the patient's breathing.

Fluticasone propionate 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 action in turn causes a decrease in the release of substances that participate in the inflammatory process (including the " histamine), thus helping to keep the airways clear and allowing the patient to breathe more easily.

What benefit has Aerivio Spiromax - Salmeterol - Fluticasone shown during the studies?

Patient studies were limited to tests to determine the bioequivalence of Aerivio Spiromax to the reference medicine, Seretide Diskus. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

Because Aerivio Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

What are the risks associated with Aerivio Spiromax - Salmeterol - Fluticasone?

Because Aerivio Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Aerivio Spiromax - Salmeterol - Fluticasone been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Aerivio Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus. Therefore, the CHMP considered that, as in the case of Seretide Diskus, the benefits outweigh the identified risks and recommended that Aerivio Spiromax be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Aerivio Spiromax - Salmeterol - Fluticasone?

The recommendations and precautions to be observed by healthcare professionals and patients in order for Aerivio Spiromax to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.

More information about Aerivio Spiromax - Salmeterol - Fluticasone

For the complete version of Aerivio Spiromax's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Aerivio Spiromax therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.

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