aphylaxis and anaphylactic shock have been reported following palivizumab administration. In some cases, fatalities have been reported (see section 4.8).
Medicinal products for the treatment of severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, should be available for immediate use following administration of palivizumab.
A moderate to severe acute infection or febrile illness may warrant delaying the use of palivizumab, unless, in the opinion of the physician, withholding palivizumab entails a greater risk. A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of palivizumab.
Palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
The efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective. The possible risk of enhanced RSV infection in the season following the season in which the patients were treated with palivizumab has not been conclusively ruled out by studies performed aiming at this particular point.
4.5 Interaction with other medicinal products and other forms of interaction
No formal interactions studies with other medicinal products were conducted, . In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines.
Palivizumab may interfere with immune-based RSV diagnostic tests, such as some antigen detection based assays. In addition, palivizumab inhibits virus replication in cell culture and, therefore, may also interfere with viral culture assays. Palivizumab does not interfere with reverse transcriptase polymerase chain reaction-based assays. Assay interference could lead to false-negative RSV diagnostic test results. Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions.
4.6 Fertility, pregnancy and lactation
Not relevant. Synagis is not indicated for use in adults. Data on fertility, pregnancy and lactation are not available.
4.7 Effects on ability to drive and use machines
Not relevant.
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 |
