Safety and pharmacokinetics of extended use of palivizumab in Saudi Arabian infants and children

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Background: The peak season of respiratory syncytial virus (RSV) infections in warmer climates may extend beyond the typical five-month RSV season of temperate regions. Additional monthly doses of palivizumab may be necessary in warmer regions to protect children at high risk for serious infection by the RSV.

Methods: In a Phase II, single-arm, single-center, noncomparative, open-label, prospective study conducted in Saudi Arabia, children at high risk for RSV infection received up to seven monthly injections of palivizumab (15 mg/kg) during the 2000–2001 RSV season. Key enrollment criteria were no previous exposure to palivizumab and gestational age ≤35 weeks, ≤6 months of age at enrollment, or chronic lung disease and ≤24 months of age at enrollment. We wished to assess the safety, immunogenicity, and pharmacokinetics of palivizumab as an extended seven-dose regimen.

Results: Of 18 enrolled patients, 17 patients received seven palivizumab injections. Seven adverse events (AEs) occurred in five patients. Bronchiolitis was the most commonly reported AE. Six serious AEs occurred in four patients. No AEs were considered related to palivizumab. Trough levels of palivizumab in serum were >40 μg/mL in most patients after the first injection and in 16/18 and 14/17 patients after the fourth and sixth injections, respectively. Except for one patient at one visit, the anti-palivizumab titer was <1:10 at all visits.

Conclusion: These data suggest that an extended palivizumab regimen of up to seven monthly doses during the RSV season exhibited an acceptable safety profile in children at high risk for RSV infection in Saudi Arabia.

Keywords: infants, open-label, palivizumab, pediatrics, pharmacokinetics, respiratory syncytial virus, safety, Saudi Arabia.

Abbreviations: AE, adverse event; CLDP, chronic lung disease of prematurity; LRTI, lower respiratory tract infection; RSV, respiratory syncytial virus

al-Alaiyan S, Pollack P, Notario GF. Safety and pharmacokinetics of extended use of palivizumab in Saudi Arabian infants and children. Drugs in Context 2015; 4: 212270. doi: 10.7573/dic.212270

Copyright © 2015 al-Alaiyan S, Pollack P, Notario GF. Distributed under the terms of the Creative Commons License Deed CC BY NC ND 3.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

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Copyright © 2015 al-Alaiyan S, Pollack P, Notario GF. Published by Drugs in Context under Creative Commons Attributions License Deed CC BY NC ND 3.0.

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Gerard F Notario, MD, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL 60064, USA.

Submitted, peer-reviewed externally

Submitted: 26 November 2014
Revised manuscript submitted: 4 February 2015
Accepted for publication: 6 February 2015
Publication date: 27 February 2015

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