Zavicefta (ceftazidime–avibactam) | Sikkerhet hos voksne

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ZAVICEFTA (ceftazidime–avibactam) has a safety and tolerability profile consistent with both cephalosporins and carbapenems^1–4

In four Phase III clinical trials, the adverse-event profile of ZAVICEFTA was similar to that seen with either best-available therapy, doripenem or meropenem.^1–4

Overall rates of any AE were low in ZAVICEFTA and comparator arms^1–4

Rates of all other categories of AEs were low and balanced across treatment arms^1–4

Most common (≥ 5%) AEs for ZAVICEFTA were positive Direct Coombs test, nausea and
diarrhoea^5*

No requirement for routine monitoring and a low potential for drug–drug interations⁵

Nausea and diarrhoea were usually
mild or moderate in intensity^1–5

An overall safety profile consistent with that of ceftazidime alone^1–5

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

Very common and common adverse reactions by system organ class

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No requirement for routine monitoring and a 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: 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, 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.

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.

ZAVICEFTA has the following contraindications:⁵

Hypersensitivity to the active substances or to any of the excipients
Hypersensitivity to any cephalosporin antibacterial agent
Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems)

ZAVICEFTA has some special warnings and precautions for use⁵

Hypersensitivity reactions
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.

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 diarrhoea
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 the 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.

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Dosing

Learn more about ZAVICEFTA’s dosing in adult and paediatric patients.

Footnotes:

*Based on data from seven Phase II and Phase III clinical trials in 2024 adult patients treated with ZAVICEFTA.⁵
^†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; DDI, drug–drug interaction; OAT, organic anion transporter.

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, 2022.

Preparatomtale

PP-ZVA-NOR-0141 Mai 2023

Sikkerhet

Pfizer AS, Org.nr 915 213 596

Postadresse: Postboks 3, 1324 Lysaker
Besøksadresse: Drammensveien 288, 0283 Oslo

Tlf.: +47 67 52 61 00

PP-BCP-NOR-0001 juni 2023

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