Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which >8,000 subjects received Ferinject, as well as those reported from the post-marketing experience (see table footnotes for details).

The most commonly reported ADR is nausea (occurring in 2.9% of the subjects), followed by injection/infusion site reactions, hypophosphatemia, headache, flushing, dizziness and hypertension. Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare.

The most serious ADR is anaphylactoid/anaphylactic reactions (rare);fatalities have been reported. See section 4.4 for further details.
Table 4: Adverse drug reactions observed during clinical trials and post-marketing experience 


Common                    Uncommon (≥1/1,000 to                           Rare                          Frequency not System Organ Class
(≥1/100 to <1/10)                   <1/100)                          (≥1/10,000 to <1/1,000)                  known(1) Immune system                                               Hypersensitivity                         Anaphylactoid/anaphylactic disorders                                                                                            reactions Metabolism and                  Hypophosphataemia
nutritional disorders
Nervous system                 Headache, dizziness          Paraesthesia, dysgeusia                                                   Loss of consciousness(1) disorders
Psychiatric disorders                                                                                Anxiety(2) Cardiac disorders                                           Tachycardia                                                               Kounis syndrome(1)
Vascular disorders             Flushing,                    Hypotension                              Phlebitis, syncope(2), hypertension                                                          presyncope(2) Respiratory, thoracic                                       Dyspnoea                                 Bronchospasm(2) and mediastinal
disorders
Gastrointestinal               Nausea                       Vomiting, dyspepsia, abdominal           Flatulence disorders                                                   pain, constipation, diarrhoea 

Skin and subcutaneous                                       Pruritus, urticaria, erythema,           Angioedema(2), pallor(2),        Face oedema(1) tissue disorders                                            rash(3)
Musculoskeletal and                                         Myalgia, back pain, arthralgia,                                           Hypophosphataemic connective tissue                                           pain in extremity, muscle                                                 osteomalacia(1) disorders                                                   spasms
General disorders and          Injection/infusion site      Pyrexia, fatigue, chest pain,            Malaise, influenza like administration site            reactions(4)                 oedema peripheral, chills                illness (whose onset may conditions                                                                                           vary from a few hours to several days) (2)
Investigations                                              Alanine aminotransferase increased, aspartate
aminostransferase increased,
gamma-glutamyltransferase
increased, blood lactate
dehydrogenase increased, blood
alkaline phosphatase increased



1.   ADRs exclusively reported in the post-marketing setting; estimated as rare.
2.   ADRs reported in the post-marketing setting which are also observed in the clinical setting.
3.  Includes the following preferred terms: rash (individual ADR determined to be uncommon) and rash erythematous, - generalised, -macular, -maculo-papular, -pruritic (all individual ADRs determined to be rare).
4. Includes but is not limited to, the following preferred terms: injection/infusion site -pain, -haematoma, -discolouration, - extravasation, -irritation, -reaction, (all individual ADRs determined to be uncommon) and -paraesthesia (individual ADR determined to be rare).
Note: ADR = Adverse drug reaction.

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/