title: Comparison of pharmacokinetics and safety of pegfilgrastim administered by two delivery methods: on-body injector and manual injection with a prefilled syringe.
abstract: OBJECTIVE
  For patients with clinically significant risk of febrile neutropenia, pegfilgrastim administration should occur the day after myelosuppressive chemotherapy; however, a variety of factors may preclude patients from returning to the clinic the next day for pegfilgrastim administration, necessitating other strategies. This study compared the pharmacokinetics and safety of pegfilgrastim administered via an on-body injector applied to the subject's skin versus manual injection using a prefilled syringe.
  
  
  METHODS
  Healthy subjects aged 18-50 years were randomized 1:1 to receive a single 6-mg subcutaneous pegfilgrastim dose from an on-body injector or a prefilled syringe. Blood for pharmacokinetic measurements was collected at baseline and prespecified time points after pegfilgrastim administration; safety was assessed throughout the 6-week study. Primary endpoints were maximum concentration (C max) and area under the concentration curve from time 0 to infinity (AUC0-inf). Secondary endpoints included safety, tolerability, and immunogenicity.
  
  
  RESULTS
  Pegfilgrastim mean AUC0-inf values for the on-body injector (n = 125) and manual injection (n = 128) were 10,900 and 11,100 h ng/mL, respectively; mean C max values were 248 and 262 ng/mL, respectively. The least squares geometric mean ratios were 0.97 for C max and 1.00 for AUC0-inf; the corresponding 90 % CIs were within the prespecified range (0.80-1.25), indicating comparable pegfilgrastim pharmacokinetics between delivery methods. Treatment-emergent adverse events (AEs) were similar between groups (injector, 86 %; manual, 85 %). Injector- or syringe-related AEs were more prevalent with the injector (13 %; manual, 4 %); none were serious. No pegfilgrastim-neutralizing antibodies were detected.
  
  
  CONCLUSIONS
  Pegfilgrastim pharmacokinetics and safety were comparable between the on-body injector and manual injection groups.
authors.affiliation: Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA, 91320, USA, byang@amgen.com.
authors.forename: Bing-Bing
authors.initials: BB
authors.lastname: Yang
authors.forename: Phuong Khanh
authors.initials: PK
authors.lastname: Morrow
authors.forename: Xikun
authors.initials: X
authors.lastname: Wu
authors.forename: Michael
authors.initials: M
authors.lastname: Moxness
authors.forename: Desmond
authors.initials: D
authors.lastname: Padhi
mesh_terms: D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D064368:Healthy Volunteers; D006801:Humans; D007279:Injections, Subcutaneous / Q000379:methods; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D013594:Syringes; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim