Arikayce (amikacin liposome inhalation suspension) / Insmed 
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  • ||||||||||  Arikayce (amikacin liposome inhalation suspension) / Insmed
    ACUTE INTERSTITIAL PNEUMONIA SECONDARY TO AMIKACIN LIPOSOME INHALATION SUSPENSION (Convention Center Exhibit Hall: Rapid Fire Area 3C) -  Jul 31, 2024 - Abstract #CHEST2024CHEST_5423;    
    CASE PRESENTATION: A 78-year-old female with chronic mycobacterium avium, previously treated with ethambutol, rifampin, and azithromycin for 1 year and 5 months, was prescribed inhaled Arikayce (amikacin) which led to acute interstitial pneumonia...Amikacin was immediately discontinued, and the patient was started on 60mg dose of prednisone daily
  • ||||||||||  Arikayce (amikacin liposome inhalation suspension) / Insmed
    Journal, Adverse events, Interview:  Qualitative Interviews Exploring Adverse Event Mitigation Strategies in Adults Receiving Amikacin Liposome Inhalation Suspension. (Pubmed Central) -  Jul 16, 2024   
    This real-world study identified a diverse set of potential AE mitigation strategies intended to help individual patients prepare for ALIS treatment, prevent the increased emergence of certain AEs, and mitigate the impact of AEs on treatment persistence. Developing a comprehensive accounting of the types of mitigation strategies in use among patients in real-world settings can inform future investigation of the effectiveness of such strategies, and support evidence-based recommendations for treatment management.
  • ||||||||||  Arikayce (amikacin liposome inhalation suspension) / Insmed
    Review, Journal:  Insights into Asymmetric Liposomes as a Potential Intervention for Drug Delivery Including Pulmonary Nanotherapeutics. (Pubmed Central) -  Jan 22, 2023   
    Arikace is the first and only FDA-approved liposomal-based inhalable therapy (amikacin liposome inhalation suspension) to treat only adults with difficult-to-treat Mycobacterium avium complex (MAC) lung disease as a combinational antibacterial treatment...This review will focus on asymmetric liposomes in contrast to conventional liposomes as a potential clinical intervention drug delivery system as well as the formulation techniques available for symmetric and asymmetric liposomes. The review aims to renew the research in liposomal nanovesicle delivery systems with particular emphasis on asymmetric liposomes as future potential carriers for enhancing drug delivery including pulmonary nanotherapeutics.
  • ||||||||||  Arikayce (amikacin liposome inhalation suspension) / Insmed
    Overview of ARIKAYCE liposomal and demonstration of its use (8J) -  Jun 22, 2022 - Abstract #ERS2022ERS_3539;    
    Significant reductions in both all-cause and respiratory disease-related hospitalizations were observed in the 12 months following ALIS initiation in real world settings. Sponsored by Insmed
  • ||||||||||  Arikace (amikacin liposome inhalation suspension) / Insmed
    Journal:  Robustness of Aerosol Delivery of Amikacin Liposome Inhalation Suspension using the eFlow® Technology. (Pubmed Central) -  Jan 4, 2022   
    The emitted dose (ED) of amikacin ranged from 473 to 523 mg (80.2 to 89.3% of loaded dose (LD)) and the fine particle dose (FPD< 5 µm) ranged from 244 to 278 mg (41.4 to 47.1% of label claim (LC)). In conclusion, while variations in the lipid concentration of the ALIS formulation and the device hole geometry had a small but significant impact on nebulization time, the critical aerosol performance parameters were maintained and remained within acceptable limits.
  • ||||||||||  Arikace (amikacin liposome inhalation suspension) / Insmed
    Review, Journal:  Liposomal drug delivery to manage nontuberculous mycobacterial pulmonary disease and other chronic lung infections. (Pubmed Central) -  Nov 29, 2021   
    Inhalation is the most direct route of delivery and has demonstrated increased efficacy of antibiotics like amikacin compared with systemic administration...Inhaled delivery of liposomal drug solutions can therefore facilitate direct access to macrophages in the lung where the infecting NTM may reside. A range of liposomal drugs are currently being evaluated in respiratory diseases.
  • ||||||||||  Arikace (amikacin liposome inhalation suspension) / Insmed
    Review, Journal:  Amikacin Liposome Inhalation Suspension in Refractory Mycobacterium avium Complex Lung Disease: A Profile of Its Use. (Pubmed Central) -  May 11, 2021   
    Its addition to guideline-based therapy (GBT) significantly improved the likelihood of achieving sputum culture conversion (defined as three consecutive monthly MAC-negative sputum cultures) by month 6 relative to GBT alone in adults with treatment-refractory MAC lung disease, with the conversion response maintained over up to 12 months' therapy and at 3 months' post treatment in significantly higher proportions of ALIS plus GBT than GBT alone recipients. ALIS as an add-on therapy to GBT was associated with an increased risk of respiratory adverse reactions compared with GBT alone, but treatment-emergent adverse events associated with systemic amikacin exposure were uncommon.
  • ||||||||||  Arikace (amikacin liposome inhalation suspension) / Insmed
    [VIRTUAL] SURVEY ON USE AND PERCEPTION OF AMIKACIN FOR TREATMENT OF MYCOBACTERIUM AVIUM COMPLEX LUNG DISEASE IN THE UK () -  Jan 23, 2021 - Abstract #BTSWM2021BTS_WM_375;    
    Background and Aim The British Thoracic Society guidelines for the management of NTM lung disease recommend the use of amikacin as part of multi-drug therapy for treatment of severe and clarithromycin-resistant Mycobacterium avium complex lung disease (MACLD)...Respondents had significant concerns regarding ototoxicity when amikacin was initiated. There was a consensus that physicians would initiate amikacin more often to achieve better outcomes for patients if the safety profile of amikacin was of a lesser concern.
  • ||||||||||  Arikayce (amikacin liposome inhalation suspension) / Insmed
    Trial completion:  Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease (clinicaltrials.gov) -  Mar 4, 2020   
    P2,  N=30, Completed, 
    Strategies for improving tolerance have been temporary discontinuation of the medication or restarting the medication thrice weekly before increasing back to daily administration. Active, not recruiting --> Completed
  • ||||||||||  Arikace (amikacin liposome inhalation suspension) / Insmed
    Journal:  Amikacin Liposome Inhalation Suspension: A Review in Mycobacterium avium Complex Lung Disease. (Pubmed Central) -  Nov 29, 2019   
    Amikacin liposome inhalation suspension (ALIS; Arikayce) [formerly known as liposomal amikacin for inhalation, or LAI] is a liposomal formulation of the aminoglycoside antibacterial drug amikacin...The addition of ALIS to GBT was associated with an increased risk of respiratory adverse events compared with GBT alone; however, serious adverse events were experienced by a similar proportion of patients in the two treatment groups. In conclusion, although current evidence for efficacy is limited to microbiological outcomes (with clinical benefit yet to be established), available data suggest that ALIS is a useful option for the treatment of patients with MAC lung disease who have not responded to conventional therapy and for whom there are limited or no alternative treatment options available.
  • ||||||||||  Arikayce (amikacin liposome inhalation suspension) / Insmed
    Trial completion, Nontuberculous mycobacteria:  Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212 (clinicaltrials.gov) -  Nov 19, 2019   
    P3,  N=163, Completed, 
    In conclusion, although current evidence for efficacy is limited to microbiological outcomes (with clinical benefit yet to be established), available data suggest that ALIS is a useful option for the treatment of patients with MAC lung disease who have not responded to conventional therapy and for whom there are limited or no alternative treatment options available. Enrolling by invitation --> Completed