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 system       Very common ≥1/10       Common               Uncommon           Rare                 Very rare         Not known organ class                                 ≥1/100 to <1/10      ≥1/1,000 to        ≥1/10,000 to         <1/10, 000        (cannot be <1/100             <1/1,000                               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 syndrome,
benign, malignant                           syndrome             acute myeloid and unspecified                                                  leukemia (including cyst and polyp)


Blood and           Leukopenia NOS,         Haemorrhage,         Pancytopenia      Bone marrow           Haemolysis failure lymphatic system    Thrombocytopenia        Anaemia,
disorders           Lymphopenia             Neutropenia
Immune system                               Hypersensitivity                        Anaphylactic         Anaphylactic disorders                                   NOS                                     reaction,            shock Anaphylactoid reaction
Nervous system      Headache                Insomnia                                 Somnolence,         Dysgeusia, disorders                                   Dizziness                                Aphonia             Paraesthesia, Peripheral sensory neuropathy,
Anticholinergic syndrome,
Neurological disorders,
Ataxia,
Encephalitis
Cardiac disorders                           Cardiac               Pericardial                               Tachycardia        Atrial dysfunction,          effusion,                                                    fibrillation such as               Myocardial palpitations,         infarction,
angina pectoris,
Cardiac failure
Arrhythmia
Vascular                                    Hypotension,                            Acute circulatory       Phlebitis disorders                                   Hypertension                            failure 

Respiratory,                                Pulmonary                                                       Pulmonary          Pneumonitis, thoracic and                                dysfunction                                                     fibrosis           Pulmonary alveolar mediastinal haemorrhage disorders
Gastrointestinal    Nausea, Vomiting        Diarrhoea,                                                      Haemorrhagic disorders                                   Constipation,                                                   oesophagitis, Stomatitis                                                      Gastrointestinal haemorrhage
Skin and                                    Alopecia,                               Erythema,                                  Stevens – subcutaneous                                Skin disorders                          Dermatitis, Pruritus,                      Johnson tissue disorders                            NOS                                     Maculopapular                              syndrome, Urticaria                               rash,
Toxic
Hyperhidrosis
Epidermal
Necrolysis
(TEN),
Drug reaction with eosinophilia and systemic symptoms
(DRESS)*


Reproductive                                Amenorrhea                                                      Infertility system and breast disorders
Hepatobiliary                                                                                                                   Hepatic disorder                                                                                                                        failure 
General disorders   Mucosal                 Pain, Chills,                                                   Multi organ and                 inflammation,           Dehydration,                                                    failure administration      Fatigue, Pyrexia        Anorexia site conditions
Investigations      Haemoglobin             AST increase, ALT decrease, Creatinine    increase, Alkaline increase, Urea increase phosphatase increase, Bilirubin increase,
Hypokalemia


Renal and urinary                                                                                                              Renal failure disorders
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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il