Palivizumab warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Warnings And Precautions
Hypersensitivity Reactions
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. Signs and symptoms may include urticaria, pruritus, angioedema, dyspnea, respiratory failure, cyanosis, hypotonia, hypotension, and unresponsiveness. 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 anaphylaxis or other significant hypersensitivity reaction occurs, administer appropriate medications (e.g., epinephrine) and provide supportive care as required. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of Synagis.
Coagulation Disorders
Synagis is for intramuscular use only. As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder.
[[respiratory syncytial virus|RSV]] Diagnostic Test Interference
Palivizumab may interfere with immunological-based [[respiratory syncytial virus|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 [[respiratory syncytial virus|RSV]] diagnostic test results. Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions [see Microbiology (12.4)].
Treatment of [[respiratory syncytial virus|RSV]] Disease
The safety and efficacy of Synagis have not been established for treatment of [[respiratory syncytial virus|RSV]] disease.
Proper Administration
The single-dose vial of Synagis does not contain a preservative. Administration of Synagis should occur immediately after dose withdrawal from the vial. The vial should not be re-entered. Discard any unused portion.[1]
References
- ↑ "SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [MEDIMMUNE, LLC]". Retrieved 8 January 2014.
Adapted from the FDA Package Insert.