PMID- 25894719
OWN - NLM
STAT- MEDLINE
DCOM- 20150729
LR  - 20220317
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Linking)
VI  - 75
IP  - 6
DP  - 2015 Jun
TI  - Comparison of pharmacokinetics and safety of pegfilgrastim administered by two 
      delivery methods: on-body injector and manual injection with a prefilled syringe.
PG  - 1199-206
LID - 10.1007/s00280-015-2731-x [doi]
AB  - PURPOSE: 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.
FAU - Yang, Bing-Bing
AU  - Yang BB
AD  - Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA, 91320, USA, byang@amgen.com.
FAU - Morrow, Phuong Khanh
AU  - Morrow PK
FAU - Wu, Xikun
AU  - Wu X
FAU - Moxness, Michael
AU  - Moxness M
FAU - Padhi, Desmond
AU  - Padhi D
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20150417
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (Recombinant Proteins)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
RN  - 3A58010674 (pegfilgrastim)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - PVI5M0M1GW (Filgrastim)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Area Under Curve
MH  - Female
MH  - Filgrastim
MH  - Granulocyte Colony-Stimulating Factor/administration & dosage/*adverse 
      effects/*pharmacokinetics
MH  - Healthy Volunteers
MH  - Humans
MH  - Injections, Subcutaneous/methods
MH  - Male
MH  - Middle Aged
MH  - Neutropenia/drug therapy
MH  - Polyethylene Glycols
MH  - Recombinant Proteins/administration & dosage/adverse effects/pharmacokinetics
MH  - Syringes
MH  - Young Adult
EDAT- 2015/04/22 06:00
MHDA- 2015/07/30 06:00
CRDT- 2015/04/21 06:00
PHST- 2014/12/16 00:00 [received]
PHST- 2015/03/19 00:00 [accepted]
PHST- 2015/04/21 06:00 [entrez]
PHST- 2015/04/22 06:00 [pubmed]
PHST- 2015/07/30 06:00 [medline]
AID - 10.1007/s00280-015-2731-x [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2015 Jun;75(6):1199-206. doi: 
      10.1007/s00280-015-2731-x. Epub 2015 Apr 17.