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 S.K, were headache (9 %) and constipation (5 %).
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Palonosetron S.K. 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                 Very rare ARs° (1/100 to<1/10)    (1/1,000 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              Somnolence, insomnia, Dizziness            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                              Dermatitis allergic, pruritic tissue disorders                                               rash
Musculoskeletal and                                         Arthralgia connective tissue disorders
Renal and urinary disorders                             Urinary retention, glycosuria
General disorders and                              Asthenia, pyrexia, fatigue,     Injection site reaction* administration site                                feeling hot, influenza like 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, disorders                                                               skin 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/