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Pediatrics Aug 2014Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial...
Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at increased risk of severe disease. Since that time, the American Academy of Pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection. The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing 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. This policy statement updates and replaces the recommendations found in the 2012 Red Book.
Topics: Antibodies, Monoclonal, Humanized; Antiviral Agents; Child, Preschool; Hospitalization; Humans; Immunocompromised Host; Infant; Infant, Premature; Infant, Premature, Diseases; Palivizumab; Respiratory Syncytial Virus Infections
PubMed: 25070315
DOI: 10.1542/peds.2014-1665 -
Journal of the Pediatric Infectious... Aug 2023In children with congenital heart disease and/or chronic lung disease entering their second respiratory syncytial virus (RSV) season, 200 mg nirsevimab had a similar...
In children with congenital heart disease and/or chronic lung disease entering their second respiratory syncytial virus (RSV) season, 200 mg nirsevimab had a similar safety profile to that of palivizumab and resulted in nirsevimab serum exposures associated with efficacy in healthy infants, supporting efficacy in this population at risk of severe RSV disease.
Topics: Infant; Child; Humans; Antibodies, Monoclonal; Antiviral Agents; Seasons; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus, Human; Lung Diseases
PubMed: 37466917
DOI: 10.1093/jpids/piad052 -
The Journal of Pediatrics Sep 2019
Topics: Academies and Institutes; Child; Gestational Age; Humans; Palivizumab; Pediatrics; United States
PubMed: 31204023
DOI: 10.1016/j.jpeds.2019.05.045 -
The New England Journal of Medicine Dec 2023
Topics: Humans; Palivizumab; Respiratory Syncytial Virus Infections; Antiviral Agents
PubMed: 38157505
DOI: 10.1056/NEJMe2312934 -
The Medical Letter on Drugs and... Oct 2023
PubMed: 37755690
DOI: 10.58347/tml.2023.1686a -
Minerva Pediatrica Dec 2018Infants born prematurely before 37 weeks of gestational age (GA) have particular anatomical, immunological and metabolic characteristics that predispose them, even in... (Review)
Review
Infants born prematurely before 37 weeks of gestational age (GA) have particular anatomical, immunological and metabolic characteristics that predispose them, even in the absence of diseases at birth, to severe morbidity. Respiratory syncytial virus (RSV) is the leading cause of hospitalization for lower respiratory tract infections (LRTI) in the first year of life, as well as an important cause of respiratory outcomes as recurrent wheezing in industrialized countries or mortality in developing countries. Prematurity is an important risk factor for hospitalization for severe RSV disease, but epidemiological, environmental and demographic risk factors also play a role in RSV infection. Currently, there is no effective antiviral therapy for the treatment of RSV infection, nor the possibility of using maternal immunization or vaccination of children to prevent infection, although numerous preclinical and clinical studies are still ongoing. Passive immunization with palivizumab has been shown to be safe and effective in preventing RSV hospitalization in children at greater risk of contracting a serious infection. Costs associated with palivizumab prophylaxis and its monthly intramuscularly administration has prompted many health institutions of different countries to implement specific recommendations, with the aim of protecting at risk infants for whom RSV infection is likely to cause serious illness or death. The cost-effectiveness ratio of prophylaxis, related to reduce hospitalization costs and the impact of the burden of RSV disease worldwide, greatly affects the drafting and the adoption of specific recommendations and the adherence to them, concerning the passive immunization with palivizumab.
Topics: Animals; Antiviral Agents; Cost-Benefit Analysis; Hospitalization; Humans; Infant, Newborn; Infant, Premature; Palivizumab; Respiratory Syncytial Virus Infections; Respiratory Tract Infections; Risk Factors
PubMed: 30334620
DOI: 10.23736/S0026-4946.18.05300-8 -
Pediatrics Jul 2022To examine the relationship between changes in American Academy of Pediatrics (AAP) guidance and palivizumab use for infants admitted to the NICU. We hypothesized that...
OBJECTIVE
To examine the relationship between changes in American Academy of Pediatrics (AAP) guidance and palivizumab use for infants admitted to the NICU. We hypothesized that each change in guidance would be associated with a change in palivizumab usage.
METHODS
This is a retrospective repeated cross-sectional study of palivizumab usage in defined subgroups of infants discharged between 1999 and 2020 using the Pediatrix Clinical Data Warehouse.
RESULTS
Palivizumab utilization increased in all groups between 1999 and 2003 and remained stable until 2013. Large changes in palivizumab use occurred between 2013 and 2015 followed by slower changes from 2016 to 2020. The largest decrease was in infants born between 29 0/7 and 31 6/7 weeks' gestational age without chronic lung disease (decreased from 87% to 21%; P < .001). The second largest absolute decrease was infants born at 32 0/7 to 34 6/7 weeks' gestational age without chronic lung disease and no major anomalies (decreased from 52% to 6%; P < .001). The decrease in term infants with major congenital heart problem was smaller (25 to 17%; P < .001). Even in the most vulnerable infants born between 22 0/7 and 28 6/7 estimated gestational age, palivizumab use declined (88% in 2013 to 74% in 2020; P < .001).
CONCLUSIONS
Early AAP guidelines had minor impacts on palivizumab use in infants discharged from the hospital from the NICU. The 2014 guidelines resulted in major changes in palivizumab use and extended into populations for which the AAP guidance remained unchanged.
Topics: Antiviral Agents; Child; Cross-Sectional Studies; Hospitalization; Humans; Infant; Infant, Newborn; Intensive Care Units, Neonatal; Lung Diseases; Palivizumab; Respiratory Syncytial Virus Infections; Retrospective Studies
PubMed: 35730329
DOI: 10.1542/peds.2021-055607 -
Pediatric Pulmonology Dec 2021
Topics: Antiviral Agents; Hospitalization; Humans; Infant; Palivizumab; Respiratory Syncytial Virus Infections
PubMed: 34547834
DOI: 10.1002/ppul.25634 -
MMW Fortschritte Der Medizin Jun 2024
Topics: Humans; Respiratory Syncytial Virus Infections; Infant; Infant, Newborn; Antiviral Agents; Palivizumab; Antibodies, Monoclonal, Humanized; Respiratory Syncytial Virus Vaccines
PubMed: 38806929
DOI: 10.1007/s15006-024-3993-1