Zavicefta Adverse Reactions

In seven Phase 2 and Phase 3 clinical trials, 2024 adult patients were treated with Zavicefta. The table as follows lists the adverse events (regardless of causality) occurring in ≥1% of patients treated with Zavicefta with or without metronidazole or comparator from Phase 2 and Phase 3 clinical trials. (See Table 16.)

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The most common adverse reactions occurring in ≥5% of patients treated with Zavicefta were Coombs direct test positive, nausea, and diarrhoea. Nausea and diarrhoea were usually mild or moderate in intensity. No clinically significant differences were observed in the safety profile across indications.
The following adverse reactions have been reported with ceftazidime alone and/or identified during the Phase 2 and Phase 3 trials with Zavicefta. Adverse reactions are classified according to frequency as defined in the Table as follows and System Organ Class. Frequency categories are derived from adverse reactions and/or potentially clinically significant laboratory abnormalities. (See Table 17.)

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Paediatric population: The safety assessment in paediatric patients from 3 months of age and older is based on the safety data from two trials in which 61 patients with cIAI (aged from 3 years to less than 18 years) and 67 patients with cUTI (aged from 3 months to less than 18 years) received Zavicefta. Overall, the safety profile in these 128 paediatric patients was similar to that observed in the adult population with cIAI and cUTI.