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ZAVICEFTA® (ceftazidime-avibactam): For the treatment of adult and paediatric patients aged 3 months and older at high risk of MDR Gram-negative infections1

ZAVICEFTA is indicated for the treatment of adult and paediatric patients aged 3 months and older with the following infections:1

- Complicated urinary tract infection (cUTI),  including pyelonephritis
- Complicated intra-abdominal infection (cIAI)
- Hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP)
- Infections due to aerobic Gram-negative organisms in patients with limited treatment options†

ZAVICEFTA demonstrated similar effectiveness to comparator therapies (meropenem or cefepime) when assessed in paediatric trials*2,3

ZAVICEFTA has a similar safety and tolerability profile in paediatric patients aged 3 months and older with cIAI and cUTI to that observed in adults*1-3

The safety assessment in paediatric patients is based on data from two trials in which 61 patients with cIAI and 67 patients with cUTI aged 3 months to < 18 years received ZAVICEFTA1

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Most common adverse reactions (>3%) for ZAVICEFTA were vomiting, diarrhoea, rash, and infusion site phlebitis2,3

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** This is an optional area where footnotes can live.

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Low rates of discontinuation due to adverse effects and no deaths were reported in either study2,3

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† Data support the use of ZAVICEFTA in adult patients with Limited Treatment Options for the treatment of bacteraemia (both primary and secondary), cSSTI, BJI, meningitis due to KPC and OXA-48 resistance mechanisms, and MDR Pseudomonas.4–10

* ZAVICEFTA has been evaluated in paediatric patients aged 3 months to < 18 years in two Phase II single-blind, randomised, comparative clinical studies, one in patients with cIAI and one in patients with cUTI (N=128). In the cIAI trial, patients received ZAVICEFTA plus metronidazole, and in the cUTI trial, patients received ZAVICEFTA alone. The primary objective in each study was to assess safety and tolerability of ZAVICEFTA (+/- metronidazole). Secondary objectives included assessment of pharmacokinetics and efficacy; efficacy was a descriptive endpoint in both studies.1,2,3​​​​​​​
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Pathogen coverage

ZAVICEFTA has broad spectrum coverage against Gram-negative pathogens including in vitro activity against MDR P.aeruginosa, CRE, including KPC- and OXA-48 producing strains, and ESBL- and AmpC-producing bacteria1-4.

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Patient Risk factors

Identifying patients at risk of MDR Gram-negative infections is vital for appropriate selection of adequate, early antimicrobial therapy to reduce the risk of fatal outcomes5.

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Abbreviations:

cUTI, complicated urinary tract infection, cIAI, complicated intra-abdominal infection; HAP, hospital-acquired pneumonia; VAP, ventilator-associated pneumonia; MDR, multi-drug resistant; KPC, Klebsiella pneumoniae carbapenemase; OXA, oxacillinase; BJI, bone and joint infection;

​​​​​​​Prescribing information

Zavicefta (ceftazidime and avibactam) 2g/0.5 g Powder for Concentrate for Solution for Infusion

Meronem® (meropenem triydrate) IV 1g 
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​​​Meronem® (meropenem triydrate) IV 500mg 

​​​​​​​References

  1. ZAVICEFTA. Summary of Product Characteristics, 2021; 
  2. Bradley JS, et al. Pediatr Infect Dis J 2019;38:816–24;
  3. Bradley JS, et al. Pediatr Infect Dis J 2019;38:920–8.
  4. Tumbarello M, et al. Clin Infect Dis 2012;55:943–50; 
  5. Caston JJ, et al. J Infect Dis 2017;59:118–23; 
  6. van Duin D, et al. J Clin Infect Dis 2016;66:163–71; 
  7. Sousa A, et al. Antimicrob Chemother 2018;73:3170–5; 
  8. Temkin E, et al. Antimicrob Agents Chemother 2017;61:e01964-16; 
  9. Shields K, et al. Antimicrob Agents Chemother 2017;61:e00883-17; 
  10. Tumbarello M, et al. Clin Infect Dis 2019;68:355–64;

PP-ZVA-GBR-1206. June 2021

Learn more about ZAVICEFTA’s Phase III clinical trials in adult patients with cUTI, cIAI and HAP/VAP.

Learn more about efficacy

Access results of ZAVICEFTA Phase III clinical trials in adult patients with cUTI, CIAI, or HAP/VAP

  • REPROVE Phase III trial (HAP/VAP)
  • RECLAIM Phase III trial (cIAI)
  • RECAPTURE Phase III trial (cUTI)
  • REPRISE Phase III trial (cIAI and cUTI)
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PP-PFE-GBR-2688. December 2020

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