Synagis (Pavlizumab)

• humanized monoclonal antibody against the RSV F glycoprotein
• licensed for use in selected infants and children younger than 24 months with BPD, preterm birth (≤35 weeks), or hemodynamically significant congenital heart disease [1,27,60].

Dose and schedule

• 15 mg/kg IM once per month for a total of five doses.
• first dose is administered before the RSV season begins (usually in November, but may vary by geographic region)
• once immunoprophylaxis is initiated, all five doses should be administered, even if the infant becomes old enough that prophylaxis is no longer indicated [1,27]. i.e an infant born at 29 weeks who is without BPD or congenital heart disease and turns 6 months old in January should still receive immunoprophylaxis in February and March.
• Immunoprophylaxis also should continue even if the infant experiences breakthrough infection [1]. This is because high-risk infants may be hospitalized more than once during an RSV season and more than one strain of RSV may cocirculate in a community.

Adverse events

• Rare cases of severe hypersensitivity reactions (<1 per 100,000 recipients) have been described after an initial dose as well as after reexposure [69].
• Palivizumab does not interfere with routine childhood immunizations.

Target groups

• AAP: infants and young children with BPD, prematurity, and hemodynamically significant congenital heart disease [1].
• other factors that may influence the decision to administer immunoprophylaxis include the presence of other conditions that predispose to respiratory illness (eg, neurologic disease), distance to and availability of hospital care for severe respiratory illness, logistical difficulties of monthly administration and cost [1,79-81]. Administration in the home setting may increase adherence to the schedule [66,82,83].
• UpToDate suggests synagis for:
  • < 2 years of age and:
    • with BPD who have required medical therapy for their pulmonary disease within 6 months of the anticipated RSV season [1].
    • who have hemodynamically significant cyanotic and acyanotic congenital heart disease [1]. Decisions should be made on the basis of degree of cardiovascular compromise (show table 1). Infants in this category who require cardiac bypass during RSV season should receive a postoperative dose of palivizumab as soon as they are medically stable because the mean serum palivizumab concentration has been observed to decrease by more than 50 percent after cardiac bypass [1,68,84].
  • < 1 yo who were born at ≤28 weeks of gestation
  • <6 months of age who were born between 29 and 32 weeks of gestation, particularly if they have risk factors for RSV, such as day care attendance or school-aged siblings [1].
  • If preemie born between 32-35 weeks gestation, give synagis if:
    • < 6 months at the start of the RSV season
    • and for older infants if they have ≥2 risk factors (day care attendance, school-age siblings, exposure to environmental air pollutants, congenital abnormalities of the airways, or severe neuromuscular disease).
  • Immunocompromised — has not been evaluated in immunocompromised children in controlled trials. Nonetheless, children with severe immunodeficiencies (eg, severe combined immunodeficiency or severe acquired immunodeficiency, children younger than two years who have undergone lung transplantation or hematopoietic stem cell transplantation) may benefit from immunoprophylaxis [1].

References: Abridged from UpToDate: Treatment and Prevention of Respiratory Syncitial Virus infection, Treatment and prevention of respiratory syncytial virus infection
Authors
Frederick E Barr, MD
Barney S Graham, MD, PhD
Section Editors
Morven S Edwards, MD
George B Mallory, MD
Deputy Editor
Mary M Torchia, MD

Last literature review version 16.3: October 2008

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