Adverse reactions : תופעות לוואי

4.8   Undesirable effects

During clinical trials, the most frequently reported adverse reactions were nausea/vomiting (73%), leucopoenia (70%), alopecia (66%), neutropenia (46%), asthenia/fatigue (46%), stomatitis/mucositis (42%), thrombocytopenia (31%) and anaemia (30%).

The following adverse reactions have been reported with Myocet during clinical studies and post marketing experience. Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, not known (cannot be estimated from the available data).

All grades              Grades ≥ 3
Infections and infestations
Neutropenic fever                       Very common              Very common Infections                              Very common                Common Herpes zoster                            Uncommon                 Uncommon Sepsis                                   Uncommon                 Uncommon Injection site infection                 Uncommon                 Not known Blood and lymphatic system disorders
Neutropenia                             Very common              Very common Thrombocytopenia                        Very common              Very common Anaemia                                 Very common              Very common Leucopenia                              Very common              Very common Lymphopenia                               Common                   Common Pancytopenia                              Common                  Uncommon Neutropenic sepsis                       Uncommon                 Uncommon Purpura                                  Uncommon                 Uncommon Metabolism and nutrition disorders
Anorexia                                Very common              Very common Dehydration                               Common                 Very common 

All grades     Grades ≥ 3
Hypokalaemia                         Common        Uncommon
Hyperglycaemia                      Uncommon       Uncommon
Psychiatric disorders
Agitation                              Uncommon     Not known
Nervous system disorders
Insomnia                                Common     Uncommon
Abnormal gait                          Uncommon    Uncommon
Dysphonia                              Uncommon    Not known
Somnolence                             Uncommon    Not known
Cardiac disorders
Arrhythmia                              Common     Uncommon
Cardiomyopathy                          Common      Common
Congestive cardiac failure              Common      Common
Pericardial effusion                   Uncommon    Uncommon
Vascular disorders
Hot flushes                             Common     Uncommon
Hypotension                            Uncommon    Uncommon
Respiratory, thoracic and mediastinal disorders
Chest pain                              Common     Uncommon
Dyspnoea                                Common     Uncommon
Epistaxis                               Common     Uncommon
Haemoptysis                            Uncommon    Not known
Pharyngitis                            Uncommon    Not known
Pleural effusion                       Uncommon    Uncommon
Pneumonitis                            Uncommon    Uncommon
Gastrointestinal disorders
Nausea/vomiting                      Very common   Very common
Stomatitis/mucositis                 Very common     Common
Diarrhoea                            Very common     Common
Constipation                           Common       Uncommon
Oesophagitis                           Common       Uncommon
Gastric ulcer                         Uncommon      Uncommon
Hepato-biliary disorders
Increased hepatic transaminases        Common      Uncommon
Increased alkaline phosphatase        Uncommon     Uncommon
Jaundice                              Uncommon     Uncommon
Increased serum bilirubin             Uncommon     Not known
Skin and subcutaneous tissue disorders
Alopecia                             Very Common     Common
Rash                                   Common       Not known
Palmar-plantar                        Not known     Not known erythrodysaesthesia syndrome
Nail disorder                          Common      Uncommon
Pruritus                              Uncommon     Uncommon
Folliculitis                          Uncommon     Uncommon

All grades              Grades ≥ 3
Dry skin                                 Uncommon                Not known Musculoskeletal, connective tissue and bone disorders
Back pain                               Common                  Uncommon Myalgia                                 Common                  Uncommon Muscle weakness                        Uncommon                 Uncommon Renal and urinary disorders
Haemorrhagic cystitis                  Uncommon                 Uncommon Oliguria                               Uncommon                 Uncommon General disorders and administration site conditions
Asthenia/Fatigue                     Very Common                 Common Fever                                Very common                 Common Pain                                 Very Common                 Common Rigors                               Very Common                Uncommon Dizziness                               Common                  Uncommon Headache                                Common                  Uncommon Weight loss                             Common                  Uncommon Injection site reaction                Uncommon                 Uncommon Malaise                                Uncommon                 Not known