II. Indications: RSV Prophylaxis (AAP guidelines, 2014)
- Congenital airway, pulmonary or neuromuscular disorder interfering with secretion clearance in age <12 months
- Hemodynamically significant Congenital Heart Disease in age <12 months
- Severe Immunodeficiency in age <24 months
- Preterm Infants with Gestational age at birth <29 weeks and age <12 months
- Chronic lung disease of prematurity
- Age <12 months
- Gestational age <32 weeks AND
- Required Supplemental Oxygen >21% for at least 28 days after delivery
- Age <24 months
- Treatment (oxygen, broncodilators, steroids, Diuretics) within 6 months of RSV season start
- Age <12 months
-
Cystic Fibrosis
- Age <12 months
- Findings of chronic lung disease or nutritional deficiency
- Age <24 months
- Weight for Length below 10th percentile OR
- Severe lung disease (respiratory related hospitalization in age <1 year or persistent CXR changes)
- Age <12 months
III. Mechanism
- Humanized mouse Monoclonal Antibody to RSV
- Provides passive Immunity to RSV in high risk infants
IV. Dosing
- Palivizumab 15 mg/kg IM monthly for up to 5 months of RSV season
- Historically RSV season has been November 1 to March 1 in U.S.
- However post-2020 Covid, peak RSV season has shifted to spring-summer
V. Efficacy
- Decreases hospitalizations by 45 to 55%
- NNT 18 to prevent one RSV related hospitalization
- Does not decrease RSV related mortality
VI. Resources
- Palivizumab Injection Solution (DailyMed)
VII. References
- Pickering (2009) Red Book, AAP, Elk Grove Village, p. 560
- (2014) Pediatrics 134(2): e620-38 [PubMed]
- Gargnani (2021) Cochrane Database Syst Rev 11(11):CD013757 +PMID: 34783356 [PubMed]
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Related Studies
Definition (NCI) | A humanized monoclonal antibody against the fusion protein (F protein) of human respiratory syncytial virus (RSV), with prophylactic application in respiratory syncytial virus infections. RSV F protein, a small envelop glycoprotein, is not only required for cytopathic syncytia resulting from cell-to-cell fusion, but is also necessary for viral spreading and evading neutralizing antibody. Palivizumab neutralizes and inhibits fusion activity of RSV, thereby preventing syncytia formation. Administration of this antibody does not interfere with other immunizations. |
Concepts | Pharmacologic Substance (T121) , Amino Acid, Peptide, or Protein (T116) , Immunologic Factor (T129) |
MSH | C111186 |
SnomedCT | 108725001, 386900007 |
English | palivizumab, palivizumab (medication), PALIVIZUMAB, palivizumab [Chemical/Ingredient], Palivizumab (product), Palivizumab (substance), Palivizumab, PALI |
Spanish | palivizumab (producto), palivizumab (sustancia), palivizumab |
Ontology: Synagis (C0723567)
Concepts | Pharmacologic Substance (T121) , Amino Acid, Peptide, or Protein (T116) , Immunologic Factor (T129) |
MSH | C111186 |
English | Synagis, palivizumab (Synagis), synagis, MedImmune brand of palivizumab, Abbott brand of palivizumab |