An inhaled liposomal formulation of amikacin1,2

ARIKAYCE is an antibacterial drug, consisting of amikacin sulfate encapsulated in liposomes. The primary mechanism of action is the disruption and inhibition of protein synthesis in the target bacteria by binding to the 30S ribosomal subunit.1

PULMOVANCE technology icon

ARIKAYCE utilizes PULMOVANCE™ technology consisting
of amikacin sulfate encapsulated in liposomes1,2

ARIKAYCE:

  • Delivers liposomal and free amikacin into the lungs through nebulization1
  • Penetrates biofilm in a study of MAC biofilms3
  • Delivers approximately 4-fold more amikacin into macrophages compared to cells exposed to the same concentrations of free amikacin based on in vitro data from a study of cultured human macrophages3
  • Delivers 5-8 times more amikacin into pulmonary macrophages compared to inhaled free amikacin in animal studies3

The clinical relevance of this is unknown.

Amikacin serum concentrations with ARIKAYCE

There is low systemic exposure to amikacin following the administration of ARIKAYCE.1,4

In the CONVERT trial, peak amikacin serum levels at steady-state with ARIKAYCE were lower than the estimated minimum Cmax observed with typical IV amikacin doses of 15 mg/kg/day in patients with mycobacterial infections.4

Following 3 months of once daily inhalation of 590-mg ARIKAYCE in patients with MAC lung disease, the mean serum AUC0-24 was 23.5 mcg*hr/mL (range: 8.0 to 46.5 mcg*hr/mL; n=12) and the mean serum Cmax was 2.8 mcg/mL (range: 1.0 to 4.4 μg/mL; n=12). The maximum Cmax and AUC0-24 were below the mean Cmax of approximately 76 mcg/mL and AUC0-24 of 154 mcg*hr/mL observed for IV administration of amikacin sulfate for injection at the approved dosage of 15 mg/kg once daily in healthy adults.1

Learn how PULMOVANCE technology works

AUC=area under the curve; IV=intravenous.