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Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.

Great Britain

Northern Ireland

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 interaction

*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
Scroll left to view table
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
Explore moreQuick LinksAccess case studies and videos

*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

Click here for ZAVICEFTA® (ceftazidime and avibactam) Prescribing Information

Click here for MERONEM® (meropenem trihydrate) Prescribing Information

Click here for TAZOCIN® (piperacillin sodium, tazobactam sodium) Prescribing Information

Click here for AMIKACIN (amikacin sulfate) Prescribing Information

Click here for TOBRAMYCIN (tobramycin) Prescribing Information


References

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.;Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62;Torres A, et al. Lancet Infect Dis 2018;18:285–95; ZAVICEFTA. Summary of Product Characteristics;​​​​​​​Mazuski JE, et al. Surg Infect 2017; 18:1-76.
Special warnings and precautions for use5Hypersensitivity reactions5

Serious and occasionally fatal hypersensitivity reactions are possible. In case of hypersensitivity reactions, treatment with ZAVICEFTA must be discontinued immediately and adequate emergency measures must be initiated. 

There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction).

Before beginning treatment, it should be established whether the patient has a history of hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of β-lactam antibacterial agent. Caution should be used if ceftazidime/ avibactam is given to patients with a history of non-severe hypersensitivity to penicillins, monobactams or carbapenems. 

Clostridium difficile-associated diarrhoea5

Clostridium difficile-associated diarrhoea has been reported with ceftazidime/ avibactam and can range in severity from mild to life-threatening.

This diagnosis should be considered in patients who present with diarrhoea during or subsequent to administration of ZAVICEFTA. 

Discontinuation of therapy with ZAVICEFTA and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given. 

Explore moreQuick LinksAccess case studies and videos


Prescribing Information

Click here for ZAVICEFTA® (ceftazidime and avibactam) Prescribing Information

Click here for MERONEM® (meropenem triydrate) Prescribing Information

Click here for AMIKACIN (amikacin sulfate) Prescribing Information

Click here for TOBRAMYCIN (tobramycin) Prescribing Information

Click here for TAZOCIN® (piperacillin sodium, tazobactam sodium) Prescribing Information


References

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.;Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62;Torres A, et al. Lancet Infect Dis 2018;18:285–95; ZAVICEFTA. Summary of Product Characteristics;Mazuski JE, et al. Surg Infect 2017; 18:1-76.
Low potential for drug-drug interactions5

In vitro drug combination studies with ZAVICEFTA have demonstrated neither synergy nor antagonism with the following drugs: metronidazole, tobramycin, levofloxacin, vancomycin, linezolid, colistin and tigecycline. 

Interaction with other antimicrobial agents: 

Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function. Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins. The clinical relevance of this finding is unknown, but due to the possibility of antagonism in vivo this drug combination should be avoided.

Interaction with other medicinal products and other forms of interaction: 

In vitro, avibactam is a substrate of OAT1 and OAT3 transporters which might contribute to the active uptake of avibactam from the blood compartment and therefore affect its excretion. Probenecid, a potent OAT inhibitor, inhibits avibactam uptake by 56–70%, potentially altering the elimination of avibactam. Since a clinical interaction trial of avibactam and probenecid has not been conducted, co-administration is not recommended.

Avibactam showed no significant inhibition of cytochrome P450 enzymes in vitro. Avibactam and ceftazidime showed no in vitro cytochrome P450 induction at clinically relevant concentrations. Avibactam and ceftazidime do not inhibit the major renal or hepatic transporters in the clinically relevant exposure range, therefore the interaction potential via these mechanisms is considered low.

Clinical data have demonstrated that there is no interaction between ceftazidime and avibactam, and between ZAVICEFTA and metronidazole.

Explore moreQuick LinksAccess case studies and videos

*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

Click here for ZAVICEFTA® (ceftazidime and avibactam) Prescribing Information

Click here for MERONEM® (meropenem triydrate) Prescribing Information

Click here for AMIKACIN (amikacin sulfate) Prescribing Information

Click here for TAZOCIN® (piperacillin sodium, tazobactam sodium) Prescribing Information

Click here for TOBRAMYCIN (tobramycin) Prescribing Information


References

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.; Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62;Torres A, et al. Lancet Infect Dis 2018;18:285–95; ZAVICEFTA. Summary of Product Characteristics;Mazuski JE, et al. Surg Infect 2017; 18:1-76.

PP-ZVA-GBR-1912 March 2024

Access results of ZAVICEFTA Phase III clinical trials in adult patients with cUTI, cIAI or HAP/VAP 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 pneumoniaeEscherichia coli and ESBL-producing strains).

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
Scroll left to view table
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
Explore moreQuick LinksAccess case studies and videos

*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

Click here for ZAVICEFTA® (ceftazidime and avibactam) Prescribing Information

Click here for MERONEM® (meropenem trihydrate) Prescribing Information

Click here for TAZOCIN® (piperacillin sodium, tazobactam sodium) Prescribing Information

Click here for AMIKACIN (amikacin sulfate) Prescribing Information

Click here for TOBRAMYCIN (tobramycin) Prescribing Information


References

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.;Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62;Torres A, et al. Lancet Infect Dis 2018;18:285–95; ZAVICEFTA. Summary of Product Characteristics;​​​​​​​Mazuski JE, et al. Surg Infect 2017; 18:1-76.
Special warnings and precautions for use5Hypersensitivity reactions5

Serious and occasionally fatal hypersensitivity reactions are possible. In case of hypersensitivity reactions, treatment with ZAVICEFTA must be discontinued immediately and adequate emergency measures must be initiated. 

There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction).

Before beginning treatment, it should be established whether the patient has a history of hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of β-lactam antibacterial agent. Caution should be used if ceftazidime/ avibactam is given to patients with a history of non-severe hypersensitivity to penicillins, monobactams or carbapenems. 

Clostridium difficile-associated diarrhoea5

Clostridium difficile-associated diarrhoea has been reported with ceftazidime/ avibactam and can range in severity from mild to life-threatening.

This diagnosis should be considered in patients who present with diarrhoea during or subsequent to administration of ZAVICEFTA. 

Discontinuation of therapy with ZAVICEFTA and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given. 

Explore moreQuick LinksAccess case studies and videos


Prescribing Information

Click here for ZAVICEFTA® (ceftazidime and avibactam) Prescribing Information

Click here for MERONEM® (meropenem triydrate) Prescribing Information

Click here for AMIKACIN (amikacin sulfate) Prescribing Information

Click here for TOBRAMYCIN (tobramycin) Prescribing Information

Click here for TAZOCIN® (piperacillin sodium, tazobactam sodium) Prescribing Information


References

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.;Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62;Torres A, et al. Lancet Infect Dis 2018;18:285–95; ZAVICEFTA. Summary of Product Characteristics;Mazuski JE, et al. Surg Infect 2017; 18:1-76.
Header
Low potential for drug-drug interactions5

In vitro drug combination studies with ZAVICEFTA have demonstrated neither synergy nor antagonism with the following drugs: metronidazole, tobramycin, levofloxacin, vancomycin, linezolid, colistin and tigecycline. 

Interaction with other antimicrobial agents: 

Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function. Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins. The clinical relevance of this finding is unknown, but due to the possibility of antagonism in vivo this drug combination should be avoided.

Interaction with other medicinal products and other forms of interaction: 

In vitro, avibactam is a substrate of OAT1 and OAT3 transporters which might contribute to the active uptake of avibactam from the blood compartment and therefore affect its excretion. Probenecid, a potent OAT inhibitor, inhibits avibactam uptake by 56–70%, potentially altering the elimination of avibactam. Since a clinical interaction trial of avibactam and probenecid has not been conducted, co-administration is not recommended.

Avibactam showed no significant inhibition of cytochrome P450 enzymes in vitro. Avibactam and ceftazidime showed no in vitro cytochrome P450 induction at clinically relevant concentrations. Avibactam and ceftazidime do not inhibit the major renal or hepatic transporters in the clinically relevant exposure range, therefore the interaction potential via these mechanisms is considered low.

Clinical data have demonstrated that there is no interaction between ceftazidime and avibactam, and between ZAVICEFTA and metronidazole.

Explore moreQuick LinksAccess case studies and videos

*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

Click here for ZAVICEFTA® (ceftazidime and avibactam) Prescribing Information

Click here for MERONEM® (meropenem triydrate) Prescribing Information

Click here for AMIKACIN (amikacin sulfate) Prescribing Information

Click here for TAZOCIN® (piperacillin sodium, tazobactam sodium) Prescribing Information

Click here for TOBRAMYCIN (tobramycin) Prescribing Information


References

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.; Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62;Torres A, et al. Lancet Infect Dis 2018;18:285–95; ZAVICEFTA. Summary of Product Characteristics;Mazuski JE, et al. Surg Infect 2017; 18:1-76.

PP-ZVA-GBR-1909 February 2024

Access results of ZAVICEFTA Phase III clinical trials in adult patients with cUTI, cIAI or HAP/VAP 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 pneumoniaeEscherichia coli and ESBL-producing strains).

Great Britain

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