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        Common            Uncommon         Rare           Very rare          Not known organ class          ≥1/10              ≥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 atypical Opportunistic                        pneumonia
infection (e.g.
Herpes zoster,
cytomegalovirus,
hepatitis B)


MedDRA system        Very common        Common             Uncommon          Rare            Very rare          Not known organ class          ≥1/10              ≥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)
Neoplasma                               Tumour lysis       Myelodysplastic benign, malignant                       syndrome           syndrome, acute and unspecified                                            myeloid
(including cyst                                            leukemia
and polyp)
Blood and            Leukopenia NOS,    Haemorrhage,       Pancytopenia      Bone marrow Haemolysis lymphatic system     Thrombocytopenia   Anaemia,                             failure 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 disorders                      Hypotension,                         Acute           Phlebitis Hypertension                         circulatory
failure
Respiratory,                            Pulmonary                                            Pulmonary          Pneumonitis thoracic and                            dysfunction                                          fibrosis           Pulmonary mediastinal                                                                                                     alveolar disorders                                                                                                       haemorrhage Gastrointestinal     Nausea, Vomiting   Diarrhoea,                                           haemorrhagic disorders                               Constipation,                                        oesophagitis, Stomatitis                                           Gastrointestinal haemorrhage
Skin and                                Alopecia,                            Erythema,                          Stevens – subcutaneous                            Skin disorders                       Dermatitis,                        Johnson tissue disorders                        NOS                                  Pruritus,                          syndrome, Urticaria                            Maculopapular                      Toxic 
MedDRA system         Very common            Common                Uncommon      Rare            Very rare     Not known organ class           ≥1/10                  ≥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)
Rash,                         Epidermal
Hyperhidrosis                 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 site   Fatigue, Pyrexia       Anorexia
conditions
Investigations        Haemoglobin            AST increase,
decrease, Creatinine   ALT increase,
increase, Urea         Alkaline
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