Palivizumab Prophylaxis Among high-risk Children with RSV Infection: AAP Guidance

The updated recommendations regarding Palivizumab Prophylaxis Among increased risk of hospitalization Children and infants with Respiratory Syncytial Virus Infection were published in the Pediatrics.

Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by a 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 become available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection.

The updated policy recommendations focus on 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.

Following is quick summary of the latest policy recommendations:

• In the first year of life, palivizumab prophylaxis is recommended for infants born before 29 weeks, 0 days' gestation.

• Palivizumab prophylaxis is not recommended for otherwise healthy infants born at or after 29 weeks, 0 days' gestation.

• In the first year of life, palivizumab prophylaxis is recommended for preterm infants with CLD of prematurity, defined as birth at <32 weeks, 0 days' gestation and a requirement for >21% oxygen for at least 28 days after birth.

• Clinicians may administer palivizumab prophylaxis in the first year of life to certain infants with hemodynamically significant heart disease.

• Clinicians may administer up to a maximum of 5 monthly doses of palivizumab (15 mg/kg per dose) during the RSV season to infants who qualify for prophylaxis in the first year of life. Qualifying infants born during the RSV season may require fewer doses. For example, infants born in January would receive their last dose in March.

• Palivizumab prophylaxis is not recommended in the second year of life except for children who required at least 28 days of supplemental oxygen after birth and who continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy).

• Monthly prophylaxis should be discontinued in any child who experiences a breakthrough RSV hospitalization.

• Children with a pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways may be considered for prophylaxis in the first year of life.

• Children younger than 24 months who will be profoundly immunocompromised during the RSV season may be considered for prophylaxis

• Insufficient data are available to recommend palivizumab prophylaxis for children with cystic fibrosis or Down syndrome.

• The burden of RSV disease and costs associated with transport from remote locations may result in broader use of palivizumab for RSV prevention in Alaska Native populations and possibly in selected other American Indian populations.

• Palivizumab prophylaxis is not recommended for the prevention of healthcare-associated RSV disease.

Reference:

Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection by Committee on infectious diseases and bronchiolitis guidelines committee published in the Pediatrics: Official journal of the American Academy of Pediatrics

DOI: https://doi.org/10.1542/peds.2014-1665