CPC A61K 31/7036 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0053 (2013.01); A61K 9/0078 (2013.01); A61K 9/127 (2013.01); A61K 31/133 (2013.01); A61K 31/407 (2013.01); A61K 31/4375 (2013.01); A61K 31/4409 (2013.01); A61K 31/4709 (2013.01); A61K 31/496 (2013.01); A61K 31/5383 (2013.01); A61K 31/546 (2013.01); A61K 31/65 (2013.01); A61K 31/7048 (2013.01); A61K 31/7052 (2013.01); A61K 45/06 (2013.01); A61P 31/04 (2018.01)] | 30 Claims |
1. A method for treating a Mycobacterium avium complex (MAC) lung infection in a patient in need thereof, comprising:
administering to the lungs of the patient a pharmaceutical composition comprising about 560 mg to about 590 mg of amikacin, or an equivalent dose of a pharmaceutically acceptable salt thereof, encapsulated in a plurality of liposomes, wherein the lipid component of the plurality of liposomes consists of an electrically neutral phospholipid and cholesterol,
wherein administering to the lungs of the patient comprises aerosolizing the pharmaceutical composition via a nebulizer to provide an aerosolized pharmaceutical composition comprising a mixture of free amikacin, or a pharmaceutically acceptable salt thereof, and liposomal complexed amikacin, or a pharmaceutically acceptable salt thereof,
wherein the aerosolized pharmaceutical composition is administered to the lungs of the patient once daily in a single dosing session, for an administration period of at least 84 days, and
wherein the treating comprises achieving at least three consecutive negative MAC sputum cultures during the administration period, wherein MAC sputum cultures are measured 28 days after initiating treatment during the administration period.
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