Adverse reactions : תופעות לוואי

4.8      Undesirable effects

Summary of the safety profile

Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus, dyspnoea, bronchospasm, hypotension (common events), flushing, hot flush, and urticaria (uncommon events), summarized in Table 1 (see section 4.4).

Tabulated list of adverse reactions
The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and from spontaneous reports with frequency not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1. Table of Adverse Reactions
System Organ             Very            Common          Uncommon         Rare        Very     Not Known Class                   Common            ≥ 1/100         ≥ 1/1000          ≥         Rare ≥ 1/10              to               to        1/10,000       <
< 1/10          < 1/100           to      1/10,000
<
1/1,000
Blood and                                               Coagulopathy
Lymphatic System
Disorders
Immune System                                                                                  Anaphylactic Disorders                                                                                      shock, Anaphylactic reaction*
Metabolism and        Hypokalaemia    Hyperglycaemia
Nutrition Disorders

Nervous System                        Convulsion,
Disorders                             Headache

Vascular Disorders                    Hypotension,      Flushing,
Hypertension      Hot flush

Respiratory,                          Bronchospasm,
Thoracic and                          Dyspnoea
Mediastinal
Disorders
Gastrointestinal      Diarrhoea,      Vomiting          Abdominal
Disorders             Nausea                            pain upper



Hepatobiliary                        Alanine             Gamma-
Disorders                            aminotransferase    glutamyltrans increased,          ferase
Blood alkaline      increased phosphatase increased,
Aspartate aminotransferase increased,
Blood bilirubin increased,
Cholestasis

Skin and                             Rash,               Urticaria
Subcutaneous                         Pruritus
Tissue Disorders
Renal and Urinary                    Blood creatinine
Disorders                            increased

General Disorders                                       Infusion site and                                                     pain
Administration
Site Conditions
* See section 4.4.

Paediatric population
The safety of anidulafungin was investigated in 68 paediatric patients (1 month to < 18 years) with ICC in a prospective, open-label, non-comparative paediatric study (see section 5.1). The frequencies of certain hepatobiliary adverse events, including alanine aminotransferase (ALT) increased and aspartate aminotransferase (AST) increased appeared at a higher frequency (7- 10%) in these paediatric patients than has been observed in adults (2%). Although chance or differences in underlying disease severity may have contributed, it cannot be excluded that hepatobiliary adverse reactions occur more frequently in paediatric patients compared to adults.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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