Likely place in therapy

Likely place in therapy

Nebulised liposomal amikacin may be an option for treating non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex in adults with limited treatment options, and who do not have cystic fibrosis. It should be used in combination with other antimicrobial agents active against Mycobacterium avium complex lung infections. Treatment should not continue for more than 6 months if sputum culture conversion has not been confirmed by then. Mycobacterium avium complex (MAC) includes Mycobacterium avium, Mycobacterium intracellulare and Mycobacterium chimaera. Nebulised liposomal amikacin is not licensed for treating NTM lung infections caused by other mycobacterial species.

One randomised controlled trial (RCT), Griffith et al. (2018), in adults with non‑cystic fibrosis MAC lung disease, found that the addition of nebulised liposomal amikacin to guideline-based antimicrobial therapy led to statistically significantly more people having sputum culture conversion (defined as 3 consecutive months with a negative sputum culture in the study) by month 6, compared with guideline-based antimicrobial therapy alone.

Nebulised liposomal amikacin is associated with adverse effects, particularly pulmonary effects (including allergic alveolitis) and systemic effects (including nephrotoxicity, ototoxicity and effects on neuromuscular conditions), that may be due to long‑term use of amikacin (European public assessment report [EPAR] for nebulised liposomal amikacin). See the summary of product characteristics (SPC) for nebulised liposomal amikacin for full details on warnings and precautions for use, including monitoring recommendations (such as monitoring auditory, vestibular and renal function). In January 2021 a Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety update on aminoglycosides and increased risk of deafness in people with mitochondrial mutations was issued.

The SPC states that nebulised liposomal amikacin, as part of a combination antimicrobial regimen, should be continued for 12 months after sputum culture conversion. The maximum duration of treatment should be no longer than 18 months. It should be started and managed by specialists experienced in treating MAC lung disease (see the SPC for nebulised liposomal amikacin).

The NICE guideline on antimicrobial stewardship makes recommendations on the effective use of new antimicrobials.