Arikayce liposomal

Amikacin is an antibiotic that belongs to the group 'aminoglycosides'. It works by disrupting the production of proteins that bacteria need to build their cell walls, thereby damaging the bacteria and eventually killing them. In this medicine, amikacin is contained in tiny fat particles known as liposomes, which allows the medicine to remain in the lung for longer.

Amikacin is an antibiotic that belongs to the group 'aminoglycosides'. It works by disrupting the production of proteins that bacteria need to build their cell walls, thereby damaging the bacteria and eventually killing them. In this medicine, amikacin is contained in tiny fat particles known as liposomes, which allows the medicine to remain in the lung for longer.

A main study in 336 patients showed that Arikayce liposomal is effective at clearing lung infections caused by MAC. After 6 months of treatment, 29% of patients on standard care who used Arikayce liposomal tested negative for the infection, compared with 9% of patients on standard care alone. In addition, 3 months after stopping treatment, 55% of patients whose infections cleared with Arikayce liposomal continued to test negative. No patient who received standard care tested negative 3 months after stopping treatment.

The most common side effects with Arikayce liposomal affect the lungs and airways: dysphonia (changes to the voice), cough, dyspnoea (difficulty breathing) and haemoptysis (coughing up blood) may affect more than 1 person in 10.

Other common side effects include pain in the mouth or throat, tiredness, diarrhoea, worsening of bronchiectasis (weakened, scarred airways and build-up of mucus) due to infection, nausea (feeling sick) and bronchospasm.

Arikayce liposomal must not be used in patients who are hypersensitive (allergic) to soya, to any aminoglycoside antibiotic or to any ingredient of this medicine. It must also not be used together with another aminoglycoside or in patients with severely impaired kidneys.

For the full list of side effects of Arikayce liposomal, see the package leaflet.

The main study showed that Arikayce liposomal can clear MAC lung infection in some patients. Although the effect of Arikayce liposomal is modest, the medicine could benefit patients who have few treatment options. In terms of its safety, Arikayce liposomal can cause significant side effects, particularly during the first months of treatment. The Agency therefore recommended restricting the medicine to patients with limited treatment options.

The Agency concluded that the benefits of Arikayce liposomal outweigh its risks and that it can be authorised in the EU.

The company will provide patients taking the medicine with an alert card to inform them of the risk of allergic alveolitis (inflammation in the lungs due to an allergy).

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arikayce liposomal have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Arikayce liposomal are continuously monitored. Side effects reported with Arikayce liposomal are carefully evaluated and any necessary action taken to protect patients.

Arikayce liposomal received a marketing authorisation valid throughout the EU on 27 October 2020.