When conducting studies on the use of the drug for preventive purposes, adverse reactions in children in the control group and in the group of children receiving the drug were similar. Adverse reactions were transient, their degree of severity varied from mild to moderate.
Side effects, possibly causally related to the use of the drug, both clinical and laboratory, are given below with frequency (frequent ≥1 / 100, but <1/10, infrequent ≥1 / 1000, but <1/100).
Preterm infants and children with bronchopulmonary dysplasia
Infections
Infrequent: viral infections, infections of the upper respiratory tract.
On the part of the blood and lymphatic system
Infrequent: leukopenia.
From the nervous system
Frequent: nervousness.
From the skin and subcutaneous tissues
Infrequent: rash.
On the part of the respiratory system
Infrequent: rhinitis, cough, wheezing.
From the side of the digestive system
Frequent: diarrhea.
Infrequent: vomiting.
Other
Frequent: increased body temperature, reaction at the injection site.
Infrequent: pain.
Laboratory indicators
Infrequent: increased activity of serum aspartate aminotransferase (ACT) and serum alanine aminotransferase (ALT), a deviation from the norms of the results of functional liver tests.
There were no clinically significant differences in adverse reactions in studies on the prevention of infections caused by RSV in preterm infants and children with bronchopulmonary dysplasia, as well as in the subgroups of children studied,differing by clinical category, sex, age, intrauterine growth, country of residence, race or ethnicity, or by the concentration of palivizumab in the blood serum. There was no difference in the safety profile between children without acute RSV infection and those who were hospitalized with the indicated diagnosis.
The abolition of the use of palivizumab due to the development of adverse reactions was rare (0.3%). The number of deaths was approximately equal in the groups of children who were prescribed palivizumab or placebo (0.4% and 1%, respectively), there was no connection with the administration of the drug.
Children with congenital heart diseases
Infections
Infrequent: gastroenteritis, upper respiratory tract infection.
From the nervous system
Infrequent: drowsiness, hyperkinesia, nervousness.
From the skin and subcutaneous tissues
Infrequent: a rash, eczema.
From the side of the cardiovascular system
Infrequent: bleeding.
On the part of the respiratory system
Infrequent: rhinitis.
From the side of the digestive system
Infrequent: vomiting, diarrhea, constipation.
Other
Frequent: increased body temperature, reaction at the injection site.
Infrequent: asthenia.
There were no clinically significant differences in adverse reactions in studies on the prevention of PCB-induced infections in children with congenital heart disease, and in the subgroups of children that differed in clinical terms. The frequency of serious side effects was significantly lower in the group of children who received palivizumab, compared with the placebo group. There were no serious side effects associated with the administration of palivizumab.
Postmarketing observations.
Since information on these side effects was reported voluntarily and was obtained on an unknown population, it is not always possible to reliably estimate their frequency and cause-and-effect relationship with the administration of palivizumab.
The following adverse reactions were noted:
from the side of the respiratory system: apnea;
from the side of blood and lymphatic system: thrombocytopenia;
from the immune system: anaphylaxis, anaphylactic shock (including fatal cases have been reported);
from the nervous system: convulsions;
from the skin and subcutaneous tissue: hives.
Formation of anti-antibodies to human immunoglobulins.
In the clinical study it was found that in the first course of therapy with the Sinagis® preparation, antibodies specific for palivizumab characterized by a low titer are formed in 1% of cases. In the second course of therapy, 55 of 56 children did not have antibodies, including two cases of antibody detection during the first course. Consequently, the formation of antibodies is temporary and has no clinical significance. In studies on children with congenital heart disease, the antigenic activity of the drug has not been studied.