title: Comparison of hypersensitivity reactions to PEG-asparaginase in children after intravenous and intramuscular administration.
abstract: BACKGROUND
  Polyethylene-glycolated (PEG)-asparaginase (PEG-ASP) is a crucial component of pediatric acute lymphoblastic leukemia therapy. Although hypersensitivity reactions to PEG-ASP occur less frequently than with other formulations, they are not uncommon and have an adverse impact on patient outcomes. Intravenous (IV) administration of PEG-ASP reduces patient pain and anxiety and is being used with increasing frequency in children.
  
  
  METHODS
  A retrospective review was performed to compare the incidence of hypersensitivity reactions to PEG-ASP in children when administered either by intramuscular (IM) or IV routes between January 2006 and May 2008.
  
  
  RESULTS
  Of 68 patients studied, 7 experienced a hypersensitivity reaction (10.3%). Two of 16 patients (12.5%) who received only IV PEG-ASP and 3 of 27 patients (11.1%) exposed to only IM PEG-ASP experienced a hypersensitivity reaction. Severe reactions (grade 3 or 4) occurred only once after 119 total doses (0.8%) of IV PEG-ASP and once after 215 total doses (0.5%) of IM PEG-ASP (P=1.0). Thrombosis or pancreatitis were rare and were not increased after IV PEG-ASP administration.
  
  
  CONCLUSIONS
  IV PEG-ASP is well tolerated and does not result in a significant increase in the incidence of hypersensitivity reactions in children.
authors.affiliation: *Childrens Mercy Hospital, Kansas City, MO †Division of Blood and Marrow Transplantion, University of Minnesota, Minneapolis, MN ‡Sigma-Tau Pharmaceuticals, Washingtonian Boulevard, Gaithersburg, MD.
authors.forename: Keith J
authors.initials: KJ
authors.lastname: August
authors.forename: Weston P
authors.initials: WP
authors.lastname: Miller
authors.forename: Amanda
authors.initials: A
authors.lastname: Dalton
authors.forename: Sara
authors.initials: S
authors.lastname: Shinnick
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001215:Asparaginase / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004342:Drug Hypersensitivity / Q000175:diagnosis*; D005260:Female; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D008297:Male; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D011092:Polyethylene Glycols; C042705:pegaspargase; D001215:Asparaginase