Palivizumab

Palivizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetRSV protein F
Clinical data
Trade namesSynagis
AHFS/Drugs.comMonograph
MedlinePlusa698034
License data
Routes of
administration
Intramuscular
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)[1]
  • UK: POM (Prescription only)[2]
  • US: ℞-only[3]
  • EU: Rx-only[4]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life18-20 days
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6470H10056N1700O2008S50
Molar mass145388.51 g·mol−1
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Palivizumab, sold under the brand name Synagis, is a monoclonal antibody produced by recombinant DNA technology used to prevent severe disease caused by respiratory syncytial virus (RSV) infections.[2][4] It is recommended for infants at high-risk for RSV due to conditions such as prematurity or other medical problems including heart or lung diseases.[2][4]

The most common side effects include fever and rash.[2][4]

Palivizumab is a humanized monoclonal antibody (IgG) directed against an epitope in the A antigenic site of the F protein of RSV. In two phase III clinical trials in the pediatric population, palivizumab reduced the risk of hospitalization due to RSV infection by 55% and 45%.[5] Palivizumab is dosed once a month via intramuscular (IM) injection, to be administered throughout the duration of the RSV season, which in based on past trends has started in Mid-September to Mid-November.[2][6][7]

Palivizumab targets the fusion protein of RSV,[8] inhibiting its entry into the cell and thereby preventing infection. Palivizumab was approved for medical use in 1998.[9]

  1. ^ https://www.tga.gov.au/resources/artg/231139 [bare URL]
  2. ^ a b c d e "Synagis 100 mg/ml solution for injection - Summary of Product Characteristics (SmPC)". (emc). 12 August 2020. Retrieved 20 August 2020.
  3. ^ "Synagis- palivizumab injection, solution". DailyMed. 12 May 2017. Retrieved 20 August 2020.
  4. ^ a b c d "Synagis EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 20 August 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ^ "Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany". ClinicalTrials.gov. 2021.
  6. ^ Borchers AT, Chang C, Gershwin ME, Gershwin LJ (December 2013). "Respiratory syncytial virus--a comprehensive review". Clinical Reviews in Allergy & Immunology. 45 (3): 331–379. doi:10.1007/s12016-013-8368-9. PMC 7090643. PMID 23575961.
  7. ^ CDC (2020-12-18). "Trends and Surveillance for RSV in the US". Centers for Disease Control and Prevention. Retrieved 2021-08-10.
  8. ^ Levinson W (2004). Medical Microbiology and Immunology (8th ed.). Lange. p. 430. ISBN 9780071431996.
  9. ^ Long SS, Pickering LK, Prober CG (2012). Principles and Practice of Pediatric Infectious Disease. Elsevier Health Sciences. p. 1502. ISBN 978-1437727029.