Palivizumab

Y. Vivian Tsai, Pharm.D., Paul G. Auwaerter, M.D.

INDICATIONS

FORMER U.S. FDA-LABELED INDICATIONS

  • Palivizumab was voluntarily discontinued in the U.S. and is no longer manufactured, distributed, or available for purchase after December 31, 2025.
    • Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease:
      • History of premature birth (≤35 weeks gestational age) and those who are 6 months of age or younger at the beginning of the RSV season.
      • History of bronchopulmonary dysplasia that required medical treatment within the previous 6 months, and who are 24 months of age or younger at the beginning of the RSV season.
      • Hemodynamically significant congenital heart disease and those who are 24 months of age or younger at the beginning of the RSV season.

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Last updated: October 11, 2026