Arikayce liposomal
Authorised
This medicine is authorised for use in the European Union
amikacin
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Arikayce liposomal is an antibiotic for treating adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water. It is used in patients with limited treatment options who do not have cystic fibrosis.
Lung infection caused by MAC is rare, and Arikayce liposomal was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 April 2014.
Arikayce liposomal contains the active substance amikacin.
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.
Product information
Latest procedure affecting product information:
PSUSA/00010882/202209
29/06/2023
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
- Arikayce liposomal
- Active substance
- amikacin sulfate
- International non-proprietary name (INN) or common name
- amikacin
- Therapeutic area (MeSH)
- Respiratory Tract Infections
- Anatomical therapeutic chemical (ATC) code
- J01GB06
Pharmacotherapeutic group
Antibacterials for systemic useTherapeutic indication
Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.
News on Arikayce liposomal
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