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ARIKAYCE targets MAC at the site of infection^1-3

Depiction of ARIKAYCE^1,3,4

amikacin liposome inhalation suspension and pulmovance technology

PULMOVANCE
liposome

Amikacin
sulfate

~0.3 μm

Mobile Target Image

PULMOVANCE™

is a technology that delivers amikacin sulfate directly to the site of infection—the lungs.^1-3

ARIKAYCE delivers:

Liposomal and free amikacin into the lungs through nebulization¹
~4 times 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 macrophages⁵
5 to 8 times more amikacin into pulmonary macrophages compared to inhaled free amikacin in animal studies⁵
Effective penetration at the site of infection⁵

The clinical significance of these data is unknown.

More uptake into macrophages as shown in an in vivo study⁵

ARIKAYCE in vivo amikacin uptake into macrophages in rats compared to inhaled free and IV amikacin⁵

Macrophages in ARIKAYCE is 17.8, for Inhaled free amikacin is 2.9, and in IV amikacin is 0.1. Airways in ARIKAYCE is 292.6, for Inhaled free amikacin is 142.5, and in IV amikacin is 4.2. Lung tissue in ARIKAYCE is 6917.0, for Inhaled free amikacin is 2771.0, and in IV amikacin is 162.1. And plasma in ARIKAYCE is 3.8, for Inhaled free amikacin is 3.1, and in IV amikacin is 22.6.

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Macrophages in ARIKAYCE is 17.8, for Inhaled free amikacin is 2.9, and in IV amikacin is 0.1. Airways in ARIKAYCE is 292.6, for Inhaled free amikacin is 142.5, and in IV amikacin is 4.2. Lung tissue in ARIKAYCE is 6917.0, for Inhaled free amikacin is 2771.0, and in IV amikacin is 162.1. And plasma in ARIKAYCE is 3.8, for Inhaled free amikacin is 3.1, and in IV amikacin is 22.6.

	ARIKAYCE	Inhaled free amikacin	IV amikacin
Macrophages	17.8	2.9	0.1
Airways	292.6	142.5	4.2
Lung tissue	6917.0	2771.0	162.1
Plasma	3.8	3.1	22.6

The clinical relevance of this is unknown.

Values represent AUC calculated for each group using the mean concentrations at each time point. AUC_2-24 was calculated for macrophage, airway, and plasma exposures, whereas AUC_0-24 was calculated for lung exposure.⁵

Limited systemic exposure with ARIKAYCE¹

Following 3 months of once-daily inhalation of 590-mg ARIKAYCE in MAC patients, the mean serum AUC_0-24 and C_max were measured and compared with the approved dosage of 15 mg/kg IV amikacin once daily in healthy adults.

Amikacin serum levels were lower with ARIKAYCE vs IV amikacin¹*

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Mean serum AUC0-24 is the mean serum level under the curve from 0 to 24 hours/ Mean serum Cmax is the maximum serum concentration achieved for one dose. Mean serum under the curve from 0 to 24 hours for ARIKAYCE was 23.5 micrograms per hour per milliliter. Mean serum under the curve for intravenous amikaycin sulfate was 154 micrograms per hour per milliliter. Maximum serum concentration for ARIKAYCE was 2.8 micrograms per milliliter. Maximum serum concentration for intravenous amikaycin sulfate was 76 micrograms per milliliter.

Mean serum AUC0-24 is the mean serum level under the curve from 0 to 24 hours/ Mean serum Cmax is the maximum serum concentration achieved for one dose. Mean serum under the curve from 0 to 24 hours for ARIKAYCE was 23.5 micrograms per hour per milliliter. Mean serum under the curve for intravenous amikaycin sulfate was 154 micrograms per hour per milliliter. Maximum serum concentration for ARIKAYCE was 2.8 micrograms per milliliter. Maximum serum concentration for intravenous amikaycin sulfate was 76 micrograms per milliliter.

| | ARIKAYCE | IV amikacin sulfate | |--------------------|----------------|---------------------| | Mean serum AUC0-24 | 23.5 mcg*hr/mL | 154 mcg*hr/mL | | Mean serum Cmax | 2.8 mcg/mL | 76 mcg/mL |

The clinical relevance of this is unknown.

In the 2018 CLSI guidelines, the MIC breakpoint for resistance is ≥128 μg/mL for ARIKAYCE⁶

An ARIKAYCE MIC level of ≤64 μg/mL is considered susceptible.⁶

See how PULMOVANCE technology works

How to Use Your Lamira Nebulizer System for ARIKAYCE

Place ARIKAYCE vial at room temperature 45 minutes before use
It is recommended to use a bronchodilator before using ARIKAYCE
Shake ARIKAYCE vial well before opening it
Pour ARIKAYCE into the medication reservoir
Begin treatment by pressing and holding the on/off button
When ARIKAYCE mist begins to flow, insert the mouthpiece and take slow, deep breaths. Then breathe normally
Clean headset and aerosol head immediately after use

Footnotes

*The maximum C_max and AUC_0-24 were below the mean C_max of approximately 76 mcg/mL and AUC_0-24 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

^†Range: 8.0 to 46.5 mcg*hr/mL; n=12.¹

^‡Range: 1.0 to 4.4 μg/mL; n=12.¹

Learn more about ARIKAYCE dosing

AUC=area under the curve; CLSI=Clinical and Laboratory Standards Institute; IV=intravenous; MIC=minimum inhibitory concentration.

References:

1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2023. 2. Griffith DE, Eagle G, Thomson R, et al; CONVERT Study Group. Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex (CONVERT): a prospective, open-label, randomized study. Am J Respir Crit Care Med. 2018;198(12):1559-1569. 3. Data on file. Insmed Incorporated. Bridgewater, NJ. 4. Olivier KN, Griffith DE, Eagle G, et al. Randomized trial of liposomal amikacin for inhalation in nontuberculous mycobacterial lung disease. Am J Respir Crit Care Med. 2017;195(6):814-823. 5. Zhang J, Leifer F, Rose S, et al. Amikacin liposome inhalation suspension (ALIS) penetrates non-tuberculous mycobacterial biofilms and enhances amikacin uptake into macrophages. Front Microbiol. 2018;9(915). doi:10.3389/fmicb.2018.00915. 6. Woods GL, Wengenack NL, Lin G, et al. Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp, and Other Aerobic Actinomycetes. Clinical and Laboratory Standards Institute. 1st ed. CLSI supplement M62. 2018:38(22).