Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The adverse reactions and frequencies below are based on publications describing clinical experience with fractionated administration of ifosfamide as monotherapy with a total dose of 4 to 12 g/m2 per course.
ADR frequency is based upon the following scale: Very common (≥1/10); Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000), Very rare (<1/10,000), Not known (adverse reactions reported in the post-marketing experience).
System Organ Class         Adverse Reaction                              Frequency Category (SOC)
INFECTIONS AND             Infections (including reactivation of latent   Common INFESTATIONS               infections)                                    Not known Sepsis (septic shock)*
NEOPLASMS BENIGN,          Secondary tumors* (including Urinary tract Not known MALIGNANT AND              carcinoma, Myelodysplastic syndrome, Acute UNSPECIFIED (INCL          leukaemia, Acute lymphocytic leukaemia,
CYCTS AND POLYPS)          Lymphoma [Non-Hodgkin's lymphoma],
Sarcomas, Renal cell carcinoma, Thyroid cancer)                                    Not known
Progressions of underlying malignancies*
BLOOD AND LYMPHATIC Myelosuppression                                      Very common SYSTEM DISORDERS    - Leukopenia                                          Very common - Thrombocytopenia*                                   Very common
- Anemia                                              Not known
- Agranulocytosis                                     Not known
Haematotoxicity*                                      Not known
- Hemolytic anemia                                    Not known
- Methaemoglobinaemia                                 Not known
Febrile bone marrow aplasia                           Not known
Disseminated intravascular coagulation                Not known
Hemolytic uremic syndrome                             Not known
Neonatal anemia                                       Not known
IMMUNE SYSTEM              Angioedema*                                    Not known DISORDERS                  Anaphylactic reaction                          Not known Immunosuppression                              Not known
Urticaria                                      Not known
Hypersensitivity reaction                      Not known
ENDOCRINE DISORDERS Syndrome of inappropriate antidiuretic                Not known hormone secretion (SIADH)
METABOLISM AND      Decreased Appetite                                    Common NUTRITION DISORDERS Tumor lysis syndrome                                  Not known Metabolic acidosis                                    Not known
Hypokalaemia                                          Not known
Hypocalcaemia                                         Not known
Hypophosphataemia                                     Not known
Hyperglycemia                                         Not known
Polydipsia                                            Not known
PSYCHIATRIC                Mutism                                         Not known DISORDERS                  Mental status change (including mania,         Not known paranoia, delusion, delirium, catatonia,
amnesia, panic attack)                         Not known
Echolalia                                      Not known
Perseveration
NERVOUS SYSTEM             Central nervous system toxicity                Not known DISORDERS                  - Encephalopathy                               Not known - Faecal incontinence                          Not known
- Status epilepticus* (convulsive and          Not known nonconvulsive)                                 Not known
- Movement disorder                            Not known
- Extrapyramidal disorder                      Not known
- Gait disturbance                             Not known
- Dysarthria                                   Not known
Peripheral neuropathy                          Not known
- Hypoesthesia                                 Not known
- Paresthesia                                  Not known
Asterixis                                      Not known
Neuralgia                                      Not known
EYE DISORDERS         Visual impairment                              Not known Conjunctivitis                                 Not known
Eye irritation                                 Not known
EAR AND LABYRINTH     Deafness                                       Not known DISORDERS             Vertigo                                        Not known Tinnitus                                       Not known
CARDIAC DISORDERS     Cardiotoxicity*                                Uncommon Arrythmia (including supraventricular and      Not known ventricular arrhythmia)                        Not known
Atrial fibrillation                            Not known
Premature atrial contractions                  Not known
Bradycardia                                    Not known
Cardiac arrest*                                Not known
Myocardial infarction                          Not known
Cardiac failure*                               Not known
Myocardial hemorrhage                          Not known
Angina pectoris                                Not known
Cardiomyopathy* (including congestive          Not known cardiomyopathy)                                Not known
Electrocardiogram ST-segment abnormal          Not known
Electrocardiogram T- wave inversion            Not known
Electrocardiogram QRS complex abnormal
VASCULAR DISORDERS Hypotension                                       Uncommon Pulmonary embolism                                Not known
Deep vein thrombosis                              Not known
Capillary leak syndrome                           Not known
Vasculitis                                        Not known
Hypertension                                      Not known
Flushing                                          Not known
RESPIRATORY,          Respiratory failure*                           Not known THORACIC, AND         Acute respiratory distress syndrome*           Not known MEDIASTINAL           Pulmonary hypertension                         Not known DISORDERS             Interstitial lung disease* (as manifested by   Not known Pulmonary fibrosis)                            Not known
Pneumonitis*                                   Not known
Pulmonary oedema*                              Not known
Pleural effusion                               Not known
Dyspnea                                        Not known
Hypoxia                                        Not known
Cough                                          Not known
GASTROINTESTINAL      Nausea/Vomiting                                Very common DISORDERS             Diarrhea                                       Uncommon Stomatitis                                     Uncommon
Enterocolitis                                  Not known
Pancreatitis                                   Not known
Ileus                                          Not known
Gastrointestinal hemorrhage                    Not known
Mucosal ulceration                             Not known
Constipation                                   Not known
Abdominal pain                                 Not known
Salivary hypersecretion                        Not known
HEPATOBILIARY         Hepatotoxicity                                 Common DISORDERS             - Hepatic failure                              Not known Veno-occlusive liver disease                 Not known
Portal vein thrombosis                       Not known
Cytolytic hepatitis                          Not known
SKIN AND                Alopecia                                     Very common SUBCUTANEOUS            Dermatitis                                   Rare TISSUE DISORDERS        Papular rash                                 Rare Toxic epidermal necrolysis                   Not known
Stevens-Johnson syndrome                     Not known
Palmar-plantar erythrodysesthesia syndrome   Not known
Radiation recall dermatitis                  Not known
Skin necrosis                                Not known
Facial swelling                              Not known
Rash                                         Not known
Pruritus                                     Not known
Erythema                                     Not known
Skin hyperpigmentation                       Not known
Hyperhidrosis                                Not known
Nail disorder                                Not known
MUSCULOSKELETAL         Rhabdomyolysis                               Not known AND CONNECTIVE          Osteomalacia                                 Not known TISSUE DISORDERS        Rickets                                      Not known Growth retardation                           Not known
Myalgia                                      Not known
Arthralgia                                   Not known
Muscle twitching                             Not known
RENAL AND URINARY       Haemorrhagic cystitis                        Very common DISORDERS               Haematuria                                   Very common Renal dysfunction*                           Very common
- Acute renal failure                        Very common
- Chronic renal failure                      Not known
- Aminoaciduria                              Not known
- Phosphaturia                               Not known
- Fanconi syndrome                           Not known
- Tubulointerstitial nephritis               Not known
Renal structural damage                      Not known
Nephrogenic diabetes insipidus               Not known
Polyuria                                     Not known
Enuresis                                     Not known
Feeling of residual urine                    Not known
REPRODUCTIVE            Infertility                                  Not known SYSTEM AND BREAST       Ovarian failure                              Not known DISORDERS               Premature menopause                          Not known Amenorrhea                                   Not known
Ovulation disorder                           Not known
Azoospermia                                  Not known
Oligospermia                                 Not known
CONGENITAL, FAMILIAL Fetal growth retardation                        Not known AND GENETIC
DISORDERS
GENERAL DISORDERS       Phlebitis                                    Common AND ADMINISTRATIVE      Fatigue                                      Uncommon SITE CONDITIONS         Malaise                                      Not known Multiorgan failure*                          Not known
General physical deterioration               Not known
Injection/Infusion site reactions            Not known
Oedema                                       Not known
Pain                                         Not known
Pyrexia                                      Not known
Chills                                            Not known
* including fatal outcomes

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.
Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il