Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Insmed Netherlands B.V., Stadsplateau 7, 3521 AZ Utrecht, Netherlands
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 (see sections 4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
ARIKAYCE liposomal should be used in conjunction with other antibacterial agents active against Mycobacterium avium Complex lung infections.
ARIKAYCE liposomal treatment should be initiated and managed by physicians experienced in the treatment of non-tuberculous lung disease due to Mycobacterium avium Complex.
The recommended dose is one vial (590 mg) administered once daily, by oral inhalation.
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.
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.
No dose adjustment is required.
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.
Inhaled liposomal amikacin has not been studied in patients with renal impairment. Use is contraindicated in severe renal impairment (see sections 4.3 and 4.4).
The safety and efficacy of inhaled liposomal amikacin in paediatric patients below 18 years of age have not been established. No data are available.
Inhalation use.
Inhaled liposomal amikacin must only be used with the Lamira Nebuliser System (nebuliser handset, aerosol head and controller). For instructions for use, see section 6.6. 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. Under recommended in vitro testing with the adult breathing pattern (500 mL tidal volume, 15 breaths per minute, and inhalation: exhalation ration of 1:1), the mean delivered dose from the mouthpiece was approximately 312 mg of amikacin (approximately 53% of label claim) with an average drug delivery rate of 22.3 mg/min assuming the nebulisation time of 14 minutes. The average mass median aerodynamic diameter (MMAD) of the nebulised aerosol droplets is about 4.7 μm with D 10 of 2.4 μm and D 90 of 9.0 μm as determined using the next generation impactor method.
Adverse reactions specifically associated with overdose of inhaled liposomal amikacin have not been identified in clinical trials. Overdose in subjects with pre-existing impaired renal function, deafness or vestibular disturbance, or impaired neuromuscular transmission may develop worsening of the pre-existing disorder.
In the event of an overdose inhaled liposomal amikacin should be stopped immediately. Where rapid removal of amikacin is indicated to prevent target organ damage, for example in subjects with renal impairment, peritoneal dialysis or haemodialysis will accelerate the extraction of amikacin from blood.
3 years.
Store in a refrigerator (2°C–8°C).
Do not freeze.
ARIKAYCE can be stored at room temperature below 25°C for up to 4 weeks.
Glass vial with bromobutyl rubber stopper and aluminium seal with plastic flip-off cap.
Pack-size of 28 vials. The carton also contains the Lamira Nebuliser Handset and 4 aerosol heads.
Discard any vial that has been frozen. Once at room temperature, any unused medicine must be discarded at the end of 4 weeks.
If the current dose is refrigerated, the vial of ARIKAYCE liposomal should be removed from the refrigerator and be allowed to come to room temperature. Prepare ARIKAYCE liposomal by shaking the vial vigorously until the contents appear uniform and well mixed. Open the vial of ARIKAYCE liposomal by flipping up the plastic top of the vial, then pulling downward to loosen the metal ring. Carefully remove the metal ring and remove the rubber stopper. Pour the content of the ARIKAYCE liposomal vial into the medicine reservoir of the Lamira Nebuliser Handset.
ARIKAYCE liposomal is administered by oral inhalation via nebulisation using the Lamira Nebuliser System. ARIKAYCE liposomal should only be used with the Lamira Nebuliser System (nebuliser handset, aerosol head, and controller). ARIKAYCE should not be used with any other type of inhalation delivery system. Do not put other medicinal products in the Lamira Nebuliser Handset.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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