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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 6/2015

01-06-2015 | Original Article

Comparison of pharmacokinetics and safety of pegfilgrastim administered by two delivery methods: on-body injector and manual injection with a prefilled syringe

Authors: Bing-Bing Yang, Phuong Khanh Morrow, Xikun Wu, Michael Moxness, Desmond Padhi

Published in: Cancer Chemotherapy and Pharmacology | Issue 6/2015

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Abstract

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.
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Metadata
Title
Comparison of pharmacokinetics and safety of pegfilgrastim administered by two delivery methods: on-body injector and manual injection with a prefilled syringe
Authors
Bing-Bing Yang
Phuong Khanh Morrow
Xikun Wu
Michael Moxness
Desmond Padhi
Publication date
01-06-2015
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 6/2015
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-015-2731-x

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