Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
In seven Phase 2 and Phase 3 clinical trials, 2024 adults were treated with Zavicefta®. 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.

Tabulated list of adverse reactions

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 and System Organ Class. Frequency categories are derived from adverse reactions and/or potentially clinically significant laboratory abnormalities, and are defined according to the following conventions: 
Very common (≥1/10)
Common (≥1/100 and <1/10)
Uncommon (≥1/1,000 and <1/100)
Rare (≥1/10,000 and <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data)

Table 6 Frequency of adverse reactions by system organ class
System Organ      Very          Common                Uncommon            Very rare           Not known Class             common

Infections and                  Candidiasis           Clostridioides infestations                    (including            difficile colitis Vulvovaginal candidiasis and       Pseudomembran
Oral candidiasis)     ous colitis

Blood and         Coombs        Eosinophilia          Neutropenia                             Agranulocytosis lymphatic         direct test system            positive      Thrombocytosis        Leukopenia                              Haemolytic disorders                                                                                     anaemia Thrombocytopenia      Lymphocytosis


Immune system                                                                                 Anaphylactic 
disorders                                                                                 reaction 
Nervous system             Headache               Paraesthesia disorders
Dizziness
Cardiac                                                                                   Kounis syndromea,* disorders

Gastrointestinal           Diarrhoea              Dysgeusia disorders
Abdominal pain

Nausea
Vomiting
Hepatobiliary              Alanine                                                        Jaundice disorders                  aminotransferase increased

Aspartate aminotransferase increased

Blood alkaline phosphatase increased
Gamma- glutamyltransferase increased

Blood lactate dehydrogenase
Increased

Skin and                   Rash maculo-                                                   Toxic epidermal subcutaneous               papular                                                        necrolysis tissue disorders
Urticaria                                                      Stevens-Johnson syndrome
Pruritus
Erythema multiforme

Angioedema

Drug Reaction with
Eosinophilia and
Systemic
Symptoms
(DRESS)



Renal and                                                 Blood creatinine   Tubulointerstitial urinary                                                   increased          nephritis disorders
Blood urea increased

Acute kidney injury

General                            Infusion site disorders and                      thrombosis administration site conditions                    Infusion site phlebitis
Pyrexia


*
ADR identified post-marketing.
a
Acute coronary syndrome associated with an allergic reaction.
Paediatric population

The safety assessment in paediatric patients is based on the safety data from two trials in which 61 patients (aged from 3 years to less than 18 years) with cIAI 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il