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Safety Profile Summary
Prescribing Information
Targeted efficacy against a broad range of MDR Gram-negative pathogens2–4
Dosing
ZAVICEFTA Overview
ZAVICEFTA is indicated for the treatment of the following infections in adult and paediatric patients from birth: complicated intra-abdominal infection (cIAI); complicated urinary tract infection (cUTI), including pyelonephritis; and hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). ZAVICEFTA is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult and paediatric patients from birth with limited treatment options.2 † ZAVICEFTA is also indicated for the treatment of adult patients with bacteraemia that occurs in association with, or is suspected to be associated with, cIAI, cUTI and HAP/VAP.2 In Phase II and Phase III clinical trials, 2024 adult patients were treated with ZAVICEFTA. The most common adverse events occurring in ≥5% of patients were Coombs direct test positive, nausea, and diarrhoea. Nausea and diarrhoea were usually mild or moderate in intensity.2 No dose adjustment required in the elderly patients and those with hepatic impairment. The dose of ZAVICEFTA in adult patients with estimated CrCl ≤50 mL/min should be adjusted according to recommended doses.2 *Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and does not inhibit many class D enzymes.2 †Data support the use of ZAVICEFTA in adult patients with limited treatment options including in primary bacteraemia, cSSTI, BJI, meningitis, febrile neutropenia, cystic fibrosis, post-transplant patients due to KPC and OXA-48 resistance mechanisms, and MDR Pseudomonas.12-26
Prescribing information
ZAVICEFTA has in vitro activity against pathogens producing AmpC, ESBL, KPC and OXA-48 enzymes.2
ZAVICEFTA’s range of in vitro activity against β-lactamases does not necessarily predict clinical success.
ZAVICEFTA has no in vitro activity against pathogens producing class B metallo-β-lactamases and is not able to inhibit many class D enzymes.2
Abbreviations:
ESBL, extended spectrum β-lactamase; KPC, Klebsiella pneumoniae carbapenemase; OXA, oxacillinase; MDR, multi drug resistant; CRE, carbapenem-resistant Enterobacterales; cSSTI, complicated skin and soft-tissue infection; BJI, bone and joint infection; CrCl, creatinine clearance.
References:
Zhang W, et al. Antimicrob Resist Infect Control 2018:7;142.
ZAVICEFTA. Summary of Product Characteristics.
Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.
Liscio JL, et al. Int J Antimicrob Agents 2015;46:266–71.
Mazuski JE, et al. Surg Infect 2017;18:1–76.
Pogue JM, et al. Clin Infect Dis 2019; 68:519–24.
Zhanel GG, et al. Drugs 2013;73:159–77.
Nicolau DP, et al. J Antimicrob Chemother 2015;70:2862–9.
Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.
Torres A, et al. Lancet Infect Dis 2018;18:285–95.
Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62.
Castón JJ, et al. Int J Infect Dis 2017;59:118–23.
van Duin D, et al. Clin Infect Dis 2018;66:163–71.
Sousa A, et al. J Antimicrob Chemother 2018;73:3170–5.
Temkin E, et al. Antimicrob Agents Chemother 2017;61:e01964-16.
Shields RK, et al. Antimicrob Agents Chemother 2017;61:e00883-17.
Tumbarello M, et al. Clin Infect Dis 2019;68:355–64.
Tumbarello M, et al. Clin Infect Dis 2021;10.1093/cid/ciab176.
Tsolaki V, et al. Antimicrob Agents Chemother 2020;64:e02320-19.
Rathish B, et al. Cureus 2021;13:e13081.
Atkin SD, et al. Infect Drug Resist 2018;11:1499–510.
Chen W, et al. Ann Transl Med 2020;8:39.
Jabbour JF, et al. Curr Opin Infect Dis 2020;33:146–54.
Aguado JM, et al. Transplant Rev (Orlando) 2018;32:36–57.
Soriano A, et al. Infect Dis Ther 2021:1–46.
Mazuski JE, et al. Infect Dis Ther 2021:1–16.
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