Next Article in Journal
Antiproliferative Activity of Neem Leaf Extracts Obtained by a Sequential Pressurized Liquid Extraction
Previous Article in Journal
Clopidogrel Pharmacokinetics in Malaysian Population Groups: The Impact of Inter-Ethnic Variability
Previous Article in Special Issue
Improved Intranasal Retentivity and Transnasal Absorption Enhancement by PEGylated Poly-l-ornithine
Article Menu
Issue 3 (September) cover image

Export Article

Open AccessArticle
Pharmaceuticals 2018, 11(3), 75; https://doi.org/10.3390/ph11030075

Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety

1
Baxalta Innovations GmbH, Shire, Industriestraße 67, 1220 Vienna, Austria
2
Shire, Bank of America Plaza, 540 W Madison St, Chicago, IL 60661, USA
3
PAREXEL International, 433 Hackensack Avenue, 10th Floor, Hackensack, NJ 07601, USA
*
Author to whom correspondence should be addressed.
Received: 25 June 2018 / Revised: 21 July 2018 / Accepted: 23 July 2018 / Published: 26 July 2018
(This article belongs to the Special Issue Polyethylene Glycol (PEG) and PEGylation in Pharmacy)
Full-Text   |   PDF [1091 KB, uploaded 26 July 2018]   |  

Abstract

Polyethylene glycol (PEG) is an inert, water soluble polymer, used for decades in pharmaceuticals. Although PEG is considered safe, concerns persist about the potential adverse effects of long-term exposure to PEG-containing therapies, specifically in children, following the introduction of PEGylated recombinant factor products used for the treatment of hemophilia. Given the absence of long-term surveillance data, and to evaluate the potential risk, we estimated PEG exposure in the pediatric population receiving PEGylated therapies with pediatric indications administered intravenously or intramuscularly. We used a range of pediatric weights and doses based on prescribing information (PI) or treatment guidelines. PIs and reporting websites were searched for information about adverse events (AEs). For a child weighing 50 kg on the highest prophylactic dose of a FVIII product, the range of total PEG exposure was 40–21,840 mg/year; for factor IX (FIX) products, the range was 13–1342 mg/year; and for other products, the range was 383–26,743 mg/year, primarily as a derivative excipient. No AE patterns attributable to PEG were found for any of these products, including potential renal, neurological, or hepatic AEs. Our analyses suggest the pediatric population has had substantial exposure to PEG for several decades, with no evidence of adverse consequences. View Full-Text
Keywords: PEGylation; safety; pediatric; biologics; polyethylene glycol; excipient; conjugation; polysorbate; hemophilia; rurioctocog alfa pegol PEGylation; safety; pediatric; biologics; polyethylene glycol; excipient; conjugation; polysorbate; hemophilia; rurioctocog alfa pegol
Figures

Figure 1

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

Supplementary material

SciFeed

Share & Cite This Article

MDPI and ACS Style

Stidl, R.; Denne, M.; Goldstine, J.; Kadish, B.; Korakas, K.I.; Turecek, P.L. Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety. Pharmaceuticals 2018, 11, 75.

Show more citation formats Show less citations formats

Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Related Articles

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Pharmaceuticals EISSN 1424-8247 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top