Palivizumab

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][3] It is recommended for infants that are high-risk because of prematurity or other medical problems such as congenital heart disease.[2][3]

Palivizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetRSV protein F
Clinical data
Trade namesSynagis
AHFS/Drugs.comMonograph
MedlinePlusa698034
License data
Pregnancy
category
  • AU: N
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only) [1]
  • US: ℞-only [2]
  • EU: Rx-only [3]
  • 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
 NY (what is this?)  (verify)

The most common side effects include fever and rash.[2][3]

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%. Palivizumab is dosed once a month via intramuscular (IM) injection, to be administered throughout the duration of the RSV season.[2]

Palivizumab targets the fusion protein of RSV,[4] inhibiting its entry into the cell and thereby preventing infection. Palivizumab was approved for medical use in 1998.[5]

Medical use

Palivizumab is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:[2][3]

  • children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season;[3]
  • children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months;[3]
  • children less than two years of age and with haemodynamically significant congenital heart disease.[3]

The American Academy of Pediatrics has published guidelines for the use of palivizumab. The most recent updates to these recommendations are based on new information regarding RSV seasonality, palivizumab pharmacokinetics, the incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates.[6]

All infants younger than one year who were born at <29 weeks (i.e. ≤28 weeks, 6 days) of gestation are recommended to use palivizumab. Infants younger than one year with bronchopulmonary dysplasia (i.e. who were born at <32 weeks gestation and required supplemental oxygen for the first 28 days after birth) and infants younger than two years with bronchopulmonary dysplasia who require medical therapy (e.g. supplemental oxygen, glucocorticoids, diuretics) within six months of the anticipated RSV season are recommended to use palivizumab as prophylaxis.[6]

Other potential target groups for palivizumab prophylaxis include:

Decisions regarding palivizumab prophylaxis for children in these groups should be made on a case-by-case basis.[6]

Side effects

Palivizumab use may cause side effects, which include, but are not limited to:[7]

Some more serious side effects include:

References
  1. "Synagis 100 mg/ml solution for injection - Summary of Product Characteristics (SmPC)". (emc). 12 August 2020. Retrieved 20 August 2020.
  2. "Synagis- palivizumab injection, solution". DailyMed. 12 May 2017. Retrieved 20 August 2020.
  3. "Synagis EPAR". European Medicines Agency (EMA). Retrieved 20 August 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. Levinson W (2004). Medical Microbiology and Immunology (8th ed.). Lange. p. 430.
  5. Long SS, Pickering LK, Prober CG (2012). Principles and Practice of Pediatric Infectious Disease. Elsevier Health Sciences. p. 1502. ISBN 978-1437727029.
  6. Brady MT, Byington CL, Davies HD, Edwards KM, Jackson MA, et al. (American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee.) (August 2014). "Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection". Pediatrics. 134 (2): 415–20. doi:10.1542/peds.2014-1665. PMID 25070315.
  7. "Palivizumab Injection". MedlinePlus Drug Information. U.S. National Library of Medicine. Retrieved 2016-01-30.
  • "Palivizumab". Drug Information Portal. U.S. National Library of Medicine.
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