PMID- 25767550
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150313
LR  - 20220321
IS  - 1745-1981 (Print)
IS  - 1740-4398 (Electronic)
IS  - 1740-4398 (Linking)
VI  - 4
DP  - 2015
TI  - Safety and pharmacokinetics of extended use of palivizumab in Saudi Arabian 
      infants and children.
LID - 10.7573/dic.212270 [doi]
LID - 212270
AB  - 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, non-comparative, 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 mug/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.
FAU - Al-Alaiyan, Saleh
AU  - Al-Alaiyan S
AD  - Neonatology Section, Department of Pediatrics, King Faisal Specialist Hospital 
      and Research Centre, Riyadh, Saudi Arabia;
FAU - Pollack, Paul
AU  - Pollack P
AD  - GI Immunology Medical Affairs, Global Pharmaceutical and Research Division, 
      AbbVie Inc., North Chicago, IL, USA;
FAU - Notario, Gerard F
AU  - Notario GF
AD  - Virology Global Project Team, Global Pharmaceutical Research and Development, 
      AbbVie Inc., North Chicago, IL, USA.
LA  - eng
PT  - Journal Article
DEP - 20150227
PL  - England
TA  - Drugs Context
JT  - Drugs in context
JID - 101262187
PMC - PMC4353192
OTO - NOTNLM
OT  - Saudi Arabia
OT  - infants
OT  - open-label
OT  - palivizumab
OT  - pediatrics
OT  - pharmacokinetics
OT  - respiratory syncytial virus
OT  - safety
EDAT- 2015/03/15 06:00
MHDA- 2015/03/15 06:01
PMCR- 2015/02/27
CRDT- 2015/03/14 06:00
PHST- 2014/11/26 00:00 [received]
PHST- 2015/02/04 00:00 [revised]
PHST- 2015/02/06 00:00 [accepted]
PHST- 2015/03/14 06:00 [entrez]
PHST- 2015/03/15 06:00 [pubmed]
PHST- 2015/03/15 06:01 [medline]
PHST- 2015/02/27 00:00 [pmc-release]
AID - dic-4-212270 [pii]
AID - 10.7573/dic.212270 [doi]
PST - epublish
SO  - Drugs Context. 2015 Feb 27;4:212270. doi: 10.7573/dic.212270. eCollection 2015.