ARIKAYCE LIPOSOMAL

ARIKAYCE liposomal treatment should be initiated and managed by physicians experienced in the treatment of non-tuberculous lung disease due to Mycobacterium avium Complex. Posology The recommended dose is one vial (590 mg) administered once daily, by oral inhalation.

Duration of treatment Treatment with inhaled liposomal amikacin, as part of a combination antibacterial regimen, should be continued for 12 months after sputum culture conversion. Treatment with inhaled liposomal amikacin should not continue beyond a maximum of 6 months if sputum culture conversion (SCC) has not been confirmed by then.

The maximum duration of treatment with inhaled liposomal amikacin should not exceed 18 months. Missed doses If a daily dose of amikacin is missed, the next dose should be administered the next day. A double dose should not be given to make up for the missed dose.

Elderly No dose adjustment is required. Hepatic impairment Inhaled liposomal amikacin has not been studied in patients with hepatic impairment. No dose adjustments based on hepatic impairment are required since amikacin is not hepatically metabolised.

Renal impairment Inhaled liposomal amikacin has not been studied in patients with renal impairment. 4). Paediatric population The safety and efficacy of inhaled liposomal amikacin in paediatric patients below 18 years of age have not been established.

No data are available. Method of administration Inhalation use Inhaled liposomal amikacin must only be used with the Lamira Nebuliser System (nebuliser handset, aerosol head and controller). 6. It must not be administered by any other route or using any other type of inhalation delivery system.

The amount delivered to the lungs will depend upon patient factors. 3 mg/min assuming the nebulisation time of 14 minutes. 0 μm as determined using the next generation impactor method.

2%). 9%). 0%). Tabulated list of adverse reactions Adverse drug reactions in Table 1 are listed according to system organ classes in MedDRA based on clinical trials and post marketing data. Within each system organ class, the following definitions apply to the frequency terminology used hereafter: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known: (cannot be estimated from the available data).

Table 1 – Summary of adverse reactions System Organ Class Adverse reactions Frequency category Infections and infestations Infective exacerbation of bronchiectasis Common Laryngitis Common Oral candidiasis Common Immune system disorders Anaphylactic reactions Not known Hypersensitivity reactions Not known System Organ Class Adverse reactions Frequency category Psychiatric disorders Anxiety Uncommon Nervous system disorders Headache Common Dizziness Common Dysgeusia Common Aphonia Common Balance disorder Common Ear and labyrinth disorders Tinnitus Common Deafness Common Respiratory, thoracic and mediastinal Dysphonia Very common disorders Dyspnoea Very common Cough Very common Haemoptysis Very common Oropharyngeal pain Common Allergic alveolitis Common Chronic Obstructive Pulmonary Disease Common Wheezing Common Productive cough Common Sputum increased Common Bronchospasm Common Pneumonitis Common Vocal cord inflammation Common Throat irritation Common Pharyngeal swelling Not known Nasal dryness Not known Epistaxis Not known Rhinorrhoea Not known Sneezing Not known Nasal Congestion Not known Gastrointestinal disorders Diarrhoea Common Nausea Common Vomiting Common Dry mouth Common Decrease of appetite Common Dysphagia Not known Glossitis Not known Glossodynia Not known Salivary hypersecretion Not known Stomatitis Not known Abdominal pain Not known Abdominal pain upper Not known Abdominal discomfort Not known Abdominal distension Not known System Organ Class Adverse reactions Frequency category Skin and subcutaneous tissue disorders Rash Common Pruritus Common Musculoskeletal and connective tissue disorders Myalgia Common Arthralgia Common Renal and urinary disorders Renal impairment Common General disorders and administration site conditions Fatigue Common Pyrexia Common Chest discomfort Common Investigations Weight decreased Common Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Anaphylaxis and hypersensitivity reactions Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking inhaled liposomal amikacin. Before therapy with inhaled liposomal amikacin is instituted, an evaluation for previous hypersensitivity reactions to aminoglycosides should take place.

If anaphylaxis or a hypersensitivity reaction occurs, inhaled liposomal amikacin should be discontinued and appropriate supportive measures should be instituted. 8). If allergic alveolitis occurs, treatment with inhaled liposomal amikacin should be discontinued and patients should be treated as medically appropriate.

Bronchospasm Bronchospasm has been reported with the use of inhaled liposomal amikacin in clinical studies. In patients with a history of reactive airway disease, asthma or bronchospasm, inhaled liposomal amikacin should be administered after using a short-acting bronchodilator.

8). Exacerbation of underlying pulmonary disease In clinical trials, exacerbation of underlying pulmonary disease (chronic obstructive pulmonary disease, infective exacerbation of chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) was reported with a higher frequency in patients treated with inhaled liposomal amikacin compared with patients not receiving inhaled liposomal amikacin.

Caution should be exercised when initiating inhaled liposomal amikacin in patients presenting with these underlying conditions. Discontinuation of treatment with inhaled liposomal amikacin should be considered if signs of exacerbation are observed.

Ototoxicity In clinical trials, ototoxicity, (including deafness, dizziness, presyncope, tinnitus, and vertigo) was reported with a higher frequency in patients treated with inhaled liposomal amikacin compared with patients not receiving inhaled liposomal amikacin.

1. Hypersensitivity to soya. Co-administration with any aminoglycoside administered via any route of administration. Severe renal impairment.