The American Academy of Pediatrics (AAP) issued recommendations for the use of palivizumab and RSV IV immune globulin (RSV-IVIG) for prophylaxis to prevent severe lower respiratory tract infections caused by respiratory syncytial virus (RSV). Both agents can significantly reduce hospitalizations in high risk infants and young children.


RSV season: usually starts in October to December and ends in March to May

(1) The season may start earlier in the South than in the North.

(2) The local health department should be consulted for disease activity updates.


Palivizumab is a humanized monoclonal antibody to RSV administered intramuscularly (IM). It is directed against the F glycoprotein on the viral surface.



no need to delay vaccination against measles or varicella

measles and varicella vaccine should not be administered until 9 months after the last dose of RSV-IVIG (contains antibodies that may limit immunogenicity)

administered once per RSV season

requires administration once per month during the RSV season (perhaps 6 or more doses)



more predictable supply

may be in short supply


may be beneficial in children with immune deficiency or HIV infection (due to other immunoglobulins present)


more adverse reactions


requires a 4 hour infusion


Recommendations for immune prophylaxis:

(1) infants and children under the age of 2 years of age with chronic lung disease (CLD, previously bronchopulmonary dysplasia) who have required medical therapy for the CLD within 6 months of the anticipated RSV season

(2) infants born <= 32 weeks of gestation or less without CLD (if born at <= 28 weeks of gestation, the prophylaxis should last until 12 months old; else up to 6 months of age)

(3) infants born <= 32 weeks of gestation or less with CLD who do not meet requirement 1 (no medical therapy for CLD in 6 months prior to RSV season)

(4) infants born 32-35 weeks of gestation with risk factors for severe disease if there is evidence of a cost benefit. This may include consideration of:

(4a) an underlying disease that may predispose to severe respiratory complications (like neurologic disease)

(4b) high risk of exposure to other children at home or in day care center

(4c) possible cardiac surgery in the near future

(4d) significant exposure to tobacco smoke or other irritants in the home

(4e) limited accessibility to health care facilities



• The recommendations include children with acyanotic congenital heart disease (patent ductus arteriosus or ventricular septal defect)

• A vial of palivizumab must be used within 6 hours of opening. It may be desirable to have several infants requiring prophylaxis treated in a few hours to minimize the risk of wastage.

• A premature newborn who is to be discharged during the RSV season or shortly before should be considered for prophylaxis prior to discharge.

• An infant with severe CLD may require prophylaxis for 2 RSV seasons.

• In the implementation I will assume that risk will involve a child who is <= 2 years at any time during the RSV season.



(1) children with cyanotic congenital heart disease (immunoprophylaxis associated with a higher surgical mortality rate): RSV-IVIG is contraindicated and palivizumab is not recommended.

(2) serious allergic reaction to product component


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