s 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 class
Frequency
ADR
Blood and lymphatic system disorders
Uncommon
Thrombocytopenia#
Immune system disorders
Not known
Anaphylaxis, anaphylactic shock (in some cases, fatalities have been reported.)#
Nervous system disorders
Uncommon
Convulsion#
Respiratory, thoracic and mediastinal disorders
Common
Apnoea#
Skin and subcutaneous tissue disorders
Very common
Uncommon
Rash
Urticaria#
General disorders and administrative site conditions
Very common
Common
Pyrexia
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 eva luated. 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
In clinical studies, three children received an overdose of more than 15 mg/kg. These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg. No medical consequences were identified in these instances.
From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose (see section 4.8). In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropri |
