Adverse reactions : תופעות לוואי

4.8          Undesirable effects

The most common adverse reactions with bendamustine hydrochloride are hematological adverse reactions (leukopenia, thrombopenia), dermatologic toxicities (allergic reactions), constitutional symptoms (fever), gastrointestinal symptoms (nausea, vomiting).

The table below reflects the data obtained with bendamustine hydrochloride.

Table 1: Adverse reactions in patients treated with bendamustine hydrochloride.
MedDRA            Very common       Common           Uncommon          Rare            Very rare        Not system organ      ≥ 1/10            ≥1/100 to        ≥1/1,000 to       ≥1/10,000 to    <1/10,000        known class                               <1/10            <1/100            <1/1, 000                        (cannot be estimated from the available data)
Infections and    Infection NOS,                     Pneumocystis      Sepsis          Pneumonia infestations      Including                          jirovecii                         primary Opportunistic                      pneumonia                         atypical infection (e.g.
Herpes zoster,
cytomegalovirus
, hepatitis B)
Neoplasma                           Tumour lysis     Myelodysplastic benign,                             syndrome         syndrome, acute malignant and                                        myeloid unspecified                                          leukemia
(including cyst and polyp)
Blood and         Leukopenia        Haemorrhage,     Pancytopenia      Bone marrow     Haemolysis lymphatic         NOS,              Anaemia,                           failure system            Thrombocytope     Neutropenia disorders         nia,
Lymphopenia

Immune system                       Hypersensitivi                     Anaphylactic    Anaphylactic disorders                           ty NOS                             reaction,       shock Anaphylactoid reaction
Nervous system    Headache          Insomnia,                          Somnolence,     Dysgeusia, disorders                           Dizziness                          Aphonia         Paraesthesia, Peripheral sensory neuropathy,
Anticholinergi c syndrome,
Neurological
disorders,
Ataxia,
Encephalitis
Cardiac                               Cardiac          Pericardial                       Tachycardia,     Atrial disorders                             dysfunction,     effusion,                                          fibrillation such as          Myocardial palpitations,    infarction,
angina           Cardiac failure pectoris,
Arrhythmia
Vascular                              Hypotension,                       Acute           Phlebitis disorders                             Hypertension                       circulatory failure
Respiratory,                          Pulmonary                                          Pulmonary        Pneumonit thoracic and                          dysfunction                                        fibrosis         is mediastinal                                                                                               Pulmonary disorders                                                                                                 alveolar haemorrha ge
Gastrointestinal   Nausea,            Diarrhoea,                                         Haemorrhagic disorders          Vomiting           Constipation,                                      oesophagitis, Stomatitis                                         Gastrointestin al haemorrhage
Skin and                              Alopecia,                          Erythema,                        Stevens – subcutaneous                                                             Dermatitis,                      Johnson tissue disorders                      Skin disorders                     Pruritus,                        syndrome, NOS                                Maculopapular                    Toxic Urticaria                          rash,                            Epidermal Hyperhidrosis                    Necrolysis
(TEN)
Drug reaction with eosinophili a and systemic symptoms
(DRESS)*
Reproductive                          Amenorrhea                                         Infertility system and breast disorders
Hepatobiliary                                                                                             Hepatic disorder                                                                                                  failure General            Mucosal            Pain, Chills,                                      Multi organ disorders and      inflammation,      Dehydration,                                       failure administration     Fatigue, Pyrexia   Anorexia site conditions
Investigations     Haemoglobin        AST increase,
decrease,          ALT increase,
Creatinine         Alkaline increase, Urea     phosphatase increase           increase,
Bilirubin
increase,
Hypokalemia
Renal and                                                                                     Renal urinary                                                                                       failure disorders                                                                                     Nephrogen ic diabetes insipidus

NOS = Not otherwise specified

(*=combination therapy with rituximab)
Description of selected adverse reactions
There have been isolated reports of necrosis after accidental extra-vascular administration and tumour lysis syndrome, and anaphylaxis.

The risk of myelodysplastic syndrome and acute myeloid leukaemias is increased in patients treated with alkylating agents (including bendamustine). The secondary malignancy may develop several years after chemotherapy has been discontinued.

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