Adverse reactions : תופעות לוואי

4.8   Undesirable effects


Summary of the safety profile
The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions. Common adverse reactions occurring with palivizumab are fever, rash, and injection site reaction.


Tabulated list of adverse reactions
Adverse reactions both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to <1/10; uncommon ≥ 1/1,000 to <1/100; rare ≥ 1/10,000 to <1/1,000) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and paediatric congenital heart disease patients.


The adverse reactions identified via post-marketing surveillance are reported voluntarily from a population of uncertain size; it is not always possible to reliably estimate their frequency or establish a causal relationship to palivizumab exposure. The frequency for these "ADRs" as presented in the table below was estimated using the safety data of the two registration clinical studies. The incidences of these reactions in these studies showed no difference between the palivizumab and placebo groups and the reactions were not drug related.


Undesirable effects in clinical studies* and post-marketing reports in paediatric patients
MedDRA system organ         Frequency                        ADR class
Blood and lymphatic         Uncommon                         Thrombocytopenia# system disorders
Immune system               Not known                        Anaphylaxis, disorders                                                    anaphylactic shock (in some cases, fatalities have been reported.)#
Nervous system              Uncommon                         Convulsion# disorders
Respiratory, thoracic       Common                           Apnoea# and mediastinal disorders
Skin and subcutaneous       Very common                      Rash tissue disorders
Uncommon                         Urticaria#
General disorders and       Very common                      Pyrexia administrative site conditions                  Common                           Injection site reaction *For full study description, see Section 5.1 Clinical studies
# ADRs identified from post-marketing surveillance


Description of selected adverse reactions
Post-marketing experience
Post-marketing serious spontaneous adverse reactions reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated. A total of 1,291 serious reports were received where palivizumab had been administered as indicated and the duration of therapy was within one season. The onset of the adverse reactions occurred after the sixth or greater dose in only 22 of these reports (15 after the sixth dose, 6 after the seventh doses and 1 after the eight dose). These adverse reactions are similar in character to those after the initial five doses.


Palivizumab treatment schedule and adverse reactions were monitored in a group of nearly 20,000 infants tracked through a patient compliance registry between 1998 and 2000. Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections,
and 27 infants had either 8 or 9 injections. Adverse reactions observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.


In an observational, post-marketing, database study, a small increase in the frequency of asthma was observed among preterm palivizumab recipients; however, the causal relationship is uncertain.


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/