Posology : מינונים

4.2    Posology and method of administration
ARIKAYCE liposomal 590 mg treatment should be initiated and managed by physicians experienced in thetreatment of non-tuberculous lung disease due to Mycobacterium avium Complex.

ARIKAYCE liposomal 590 mg should be used in conjunction with other antibacterial agents active against Mycobacterium avium Complex lung infections.

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. Use is contraindicated in severe renal impairment (see sections 4.3 and 4.4).

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). 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.

ARIKAYCE liposomal 590 mg is administered only using a Lamira Nebuliser System. Like all other nebulized treatments, 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 nebulization time of 14 minutes. The average mass median aerodynamic diameter (MMAD) of the nebulized aerosol droplets is about 4.7 µm with D10 of 2.4 µm and D90 of 9.0 µm as determined using the next generation impactor method.