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ZAVICEFTA® (ceftazidime-avibactam): A safety and tolerability profile consistent with both cephalosporins and carbapenems1-4

Adverse Events

Special Warnings and Precautions for Use

Drug-drug interactions

*In four Phase III clinical trials, the adverse event profile of ZAVICEFTA was similar to that seen with either best available therapy, doripenem or meropenem1–4

  • Overall rates of any AE were low in the ZAVICEFTA and comparator arms1–4
  • Rates of all other AE categories were low and balanced across treatment arms1–4
  • Most common (>5%) AEs for ZAVICEFTA were positive direct Coombs test, nausea and diarrhoea5*
  • Nausea and diarrhoea were usually mild or moderate in intensity1-5
  • Low potential for drug-drug interactions5

*Based on data from seven Phase II and Phase III clinical trials in 2024 adult patients treated with ZAVICEFTA.5

An overall safety profile consistent with that of ceftazidime alone1-6

Incidence of very common (≥1/10) and common (≥1/100 and <1/10) adverse drug reactions occurring in patients receiving ZAVICEFTA during Phase II and III clinical trials:5

Very common and common adverse reactions by system organ class

System organ class

Very common

Common

Infections and infestations

Candidiasis (including vulvovaginal candidiasis and oral candidiasis)

Blood and lymphatic system disorders

Coombs direct test positive*

Eosinophilia, thrombocytosis, thrombocytopenia

Nervous system disorders

Headache, dizziness

Gastrointestinal disorders

Diarrhoea, abdominal pain, nausea, vomiting

Hepatobiliary disorders

Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, blood lactate dehydrogenase increased

Skin and subcutaneous tissue disorders

Rash maculopapular, urticaria, pruritus

General disorders and administration site conditions

Infusion site thrombosis, infusion site phlebitis, pyrexia

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*ZAVICEFTA use may cause development of a positive DAGT or Coombs test, which may interfere with the cross-matching of blood and/or may cause drug induced immune haemolytic anaemia. While DAGT seroconversion in patients receiving ZAVICEFTA was very common in clinical studies (the estimated range of seroconversion across Phase III studies was 3.2% to 20.8% in patients with a negative Coombs test at baseline and at least one follow-up test), there was no evidence of haemolysis in patients who developed a positive DAGT on treatment. However, the possibility that haemolytic anaemia could occur in association with ZAVICEFTA treatment cannot be ruled out. Patients experiencing anaemia during or after treatment with ZAVICEFTA should be investigated for this possibility.5

Abbreviations

AE, Adverse event; DAGT, direct antiglobulin test; cUTI, complicated urinary tract infection, cIAI, complicated intra-abdominal infection; HAP, hospital-acquired pneumonia; VAP, ventilator-associated pneumonia; MDR, multi-drug resistant;​​​​​​​​​​​​​​

Prescribing information​​​​​​​

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

Meronem® (meropenem triydrate) IV 1g

Meronem® (meropenem triydrate) IV 500mg

Tazocin® (piperacillin sodium, tazobactam sodium) 2g/0.25g Powder for Solution for Infusion

Tazocin® (piperacillin sodium, tazobactam sodium) 4g/0.5g Powder for Solution for Infusion

Amikacin (amikacin sulfate)  500mg/2ml solution for injection
Legal Category: Prescription Only Medicine (POM)
NHS Price: 5 vial pack £60.00
Click here for the Summary of Product Characteristics 

Tobramycin (tobramycin)
Tobramycin 240mg/6ml solution for injection
Legal Category: Prescription Only Medicine (POM) 
Basic NHS Cost: 1 vial £19.20
Click here for the Summary of Product Characteristics

Tobramycin 80mg/2ml solution for injection 
Legal Category: Prescription Only Medicine (POM) 
Basic NHS Cost: 5 vial £20.80
​​​​​​​Click here for the Summary of Product Characteristics

Gentamicin (gentamicin sulfate) 40 mg/ml Injection
Legal Category: Prescription Only Medicine (POM)
NHS Price: 5 vial £20.00 
Click here for the Summary of Product Characteristics

Ciprofloxacin (ciprofloxacin lactate) 2 mg/ml Solution for Infusion
Legal Category: Prescription Only Medicine (POM)
NHS Price: 10 bag £200.00 
Click here for the Summary of Product Characteristics​​​​​​​

References
  1. Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.
  2. Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.;
  3. Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62;
  4. Torres A, et al. Lancet Infect Dis 2018;18:285–95; 
  5. ZAVICEFTA. Summary of Product Characteristics;
  6. ​​​​​​​Mazuski JE, et al. Surg Infect 2017; 18:1-76.
PP-ZVA-GBR-0841. June 2021

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)

Alex Soriano

Infectious Disease Physician at Hospital Clinic in Barcelona, Spain, summarises key ZAVICEFTA data against other β-lactam/β-lactamase inhibitor combinations. He discusses ZAVICEFTA’s in vitro activity and broad-spectrum coverage against MDR P. aeruginosa and Enterobacteriaceae (including Klebsiella pneumoniae, Escherichia coli and ESBL-producing strains).

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PP-PFE-GBR-2688. December 2020

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