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Synagis safety profile in high-risk patients based on 2 clinical studies

IMpact study: The most frequent adverse events judged related to study drug1*

EVENT
Placebo (n=500)
Synagis (n=1,002)
P value
Fever
3.0%
2.8%
0.870
Nervousness
2.6%
2.5%
0.865
Injection-site reaction
1.6%
2.3%
0.444
Diarrhea
0.4%
1.0%
0.357

Reported events in at least 1% of children in the palivizumab group are provided along with the corresponding incidence in the placebo group. These represent adverse events reported by the investigator and include those identified by protocol-mandated testing and other clinically indicated evaluations.1

In postmarketing experience, the adverse reactions occurring ≥10% and at least 1% more frequently than placebo
are fever and rash.1

FELTES ET AL TRIAL: The most frequently reported adverse events in infants and children with CHD, regardless of whether it was drug-related2†

EVENT
Placebo (n=648)
Synagis (n=639)
Fever
23.9%
27.1%
Infection
2.9%
5.6%
Injection-site reaction
2.2%
3.4%
Upper respiratory infection
46.1%
47.4%
Conjunctivitus
9.3%
11.3%
Arrythmia
1.7%
3.1%
Cyanosis
6.9%
9.1%

Few adverse events were reported at an absolute incidence ≥1% higher in the Synagis group compared to the placebo group.

None of the events reported as arrhythmia and 1 reported as cyanosis (placebo recipient) were judged related to the study drug.

In postmarketing experience, the adverse reactions occurring ≥10% and at least 1% more frequently than placebo are fever and rash.2

Important Safety Information

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). The recommended dose of Synagis is 15 mg/kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season.

The efficacy of Synagis at doses less than 15 mg/kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.

Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis. Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to Synagis. Other acute hypersensitivity reactions, which may be severe, have also been reported on initial exposure or re-exposure to Synagis. The relationship between these reactions and the development of antibodies to Synagis is unknown. If a significant hypersensitivity reaction occurs with Synagis, its use should be permanently discontinued. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of Synagis. As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder. Palivizumab may interfere with immunological-based RSV diagnostic tests, such as some antigen detection-based assays.

Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. In post-marketing reports, cases of severe thrombocytopenia (platelet count <50,000/microliter) and injection site reactions have been reported.

Please see full Prescribing Information for Synagis, including Patient Information.