Adverse reactions : תופעות לוואי

4.8    Undesirable effects

In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9%) and constipation (5%).

In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron. These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100). Very rare (<1/10,000) adverse reactions were reported post-marketing.
Within each frequency grouping, adverse reactions are presented below in order of decreasing seriousness.


System organ class                  Common ARs           Uncommon ARs (≥1/1,000               Very rare ARs° (≥1/100 to <1/10)          to <1/100)                        (<1/10,000) Immune system disorders                                                                  Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock
Metabolism and nutrition                                Hyperkalaemia, metabolic disorders                                               disorders, hypocalcaemia, hypokalaemia, anorexia,
hyperglycaemia, appetite decreased
Psychiatric disorders                                    Anxiety, euphoric mood Nervous system disorders          Headache, dizziness Somnolence, insomnia, paraesthesia, hypersomnia,
peripheral sensory neuropathy
Eye disorders                                            Eye irritation, amblyopia Ear and labyrinth disorders                               Motion sickness, tinnitus Cardiac disorders                                       Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia,
sinus arrhythmia,
supraventricular extrasystoles
Vascular disorders                                      Hypotension, hypertension, vein discolouration, vein distended
Respiratory, thoracic and                               Hiccups mediastinal disorders
Gastrointestinal disorders        Constipation,         Dyspepsia, abdominal pain, diarrhoea             abdominal pain upper, dry mouth, flatulence
Hepatobiliary disorders                                 Hyperbilirubinaemia Skin and subcutaneous tissue                            Dermatitis allergic, pruritic disorders                                               rash
Musculoskeletal and                                     Arthralgia connective tissue disorders
Renal and urinary disorders                             Urinary retention, glycosuria Asthenia, pyrexia, fatigue,   Injection site reaction*
General disorders and feeling hot, influenza like administration site conditions illness
Investigations                                          Elevated transaminases, electrocardiogram QT prolonged
° From post-marketing experience
* Includes the following: burning, induration, discomfort and pain


Paediatric population
In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg). The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%.
System organ class                            Common ARs                  Uncommon ARs (≥1/100 to <1/10)          (≥1/1,000 to <1/100)
Nervous system disorders               Headache                    Dizziness, dyskinesia Cardiac disorders
Electrocardiogram QT prolonged conduction disorder, sinus tachycardia
Respiratory, thoracic and                                          Cough, dyspnoea, epistaxis mediastinal disorders
Skin and subcutaneous tissue                                       Dermatitis allergic, pruritus, skin disorders                                                          disorder, urticaria General disorders and                                              Pyrexia, infusion site pain, administration site conditions                                     infusion site reaction, pain 
Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles.

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