ZAVICEFTA® (CEFTAZIDIME AND AVIBACTAM)| Broad Coverage

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Broad Coverage

ZAVICEFTA (ceftazidime/avibactam) is a combination of ceftazidime, an antipseudomonal cephalosporin, and avibactam, a novel β-lactamase inhibitor ^1,2,3

For the treatment of patients at high risk of MDR Gram-negative infections with suspected or documented pathogens, including:^1,2–5

Guidelines

ZAVICEFTA (ceftazidime–avibactam) is recommended by IDSA guidance* as a preferred treatment option for MDR Gram-negative infections caused by CRE^‡ and DTR-P. Aeruginosa^6 ‡

^*The IDSA guidance recommends doses and infusion times for products that might be inconsistent with their approved prescribing information. Please check with your appropriate local authority for approved uses and indications.⁶
ZAVICEFTA (ceftazidime–avibactam) is not approved for combination therapy use in MBL-producing organisms. IDSA guidance on treatment recommendations pertaining to MBL-producing CRE are not discussed in this document and not recommended or endorsed by Pfizer.^1,6 ^†For infections outside of the urinary tract, resistant to both ertapenem and meropenem, AND carbapenemase testing results either not available or negative.⁶ ^‡DTR P. aeruginosa is defined as P. aeruginosa exhibiting non-susceptibility to all of the following: piperacillin-tazobactam, ceftazidime, cefepime, aztreonam, meropenem, imipenem-cilastatin, ciprofloxacin and levofloxacin.^{6 §}Defined as a UTI occurring in association with a structural or functional abnormality of the genitourinary tract, or any UTI in a male patient.⁶ ^||Meropenem-vaborbactam, imipenem-cilastatin-relebactam and cefiderocol are also preferred treatment options.⁶ ^¶Meropenem-vaborbactam and imipenem-cilastatin-relebactam are also preferred treatment options.^{6 **}KPC identified (or carbapenemase positive but identity of carbapenemase unknown). ^††Ceftolozane-tazobactam, imipenem-relebactam, cefiderocol and a single dose of an aminoglycoside are also preferred treatment options.⁶ ^‡‡Ceftolozane-tazobactam, imipenem-cilastatin-relebactam and cefiderocol are also preferred treatment options.^{6 §§}Ceftolozane-tazobactam and imipenem-cilastatin-relebactam are also preferred treatment options.⁶

ZAVICEFTA Overview

ZAVICEFTA is indicated for the treatment of the following infections in adult and paediatric patients aged 3 months and older: 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 aged 3 months and older with limited treatment options.¹ ^† 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.¹ 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.¹ No dose adjustment required in the elderly, patients with mild renal impairment (estimated CrCl ≥51 to ≤80 mL/min) 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.¹ *Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and does not inhibit many class D enzymes.¹ ^†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.^13-27

Prescribing information

Zavicefta® (avibactam sodium, ceftazidime pentahydrate)

Zavicefta® (avibactam sodium, ceftazidime pentahydrate) 2g/0.5g powder for concentrate for solution for infusion)

Meronem® (meropenem trihydrate)

Meronem® (Meropenem Trihydrate) Meronem I.V. 1g

Abbreviations:

CRE, carbapenem-resistant Enterobacterales; DTR, difficult-to-treat resistance; ESBL, extended spectrum β-lactamase; KPC, Klebsiella pneumoniae carbapenemase; MBL, metallo-β-lactamase; MDR, multidrug-resistant; OXA, oxacillinase;UTI, urinary tract infection; cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; HAP, hospital-acquired pneumonia; VAP, ventilator-associated pneumonia; cSSTI, complicated skin and soft tissue infection.

References:

ZAVICEFTA. Summary of Product Characteristics, 2022.

Liscio JL, et al. Int J Antimicrob Agents 2015;46:266–71.

Stone GG, et al. Antimicrob Agents Chemother 2020;64:e02356-19.

Mazuski JE, et al. Surg Infect 2017;18:1–76.

Pogue JM, et al. Clin Infect Dis 2019; 68:519–24.

Tamma PD, et al. Infectious Diseases Society of America Antimicrobial Resistant Treatment Guidance: Gram Negative Bacterial Infections. 2020. Available at: https://www.idsociety.org/practice-guideline/amr-guidance (last accessed September 2022).

Zhanel GG, et al. Drugs 2013;73:159–77.

Nicolau DP, et al. J Antimicrob Chemother 2015;70:2862–9.

Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.

Torres A, et al. Lancet Infect Dis 2018;18:285–95. Abbreviations & references

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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