Preprint Article Version 1 This version is not peer-reviewed

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

Version 1 : Received: 25 June 2018 / Approved: 26 June 2018 / Online: 26 June 2018 (12:15:59 CEST)

A peer-reviewed article of this Preprint also exists.

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. 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.

Journal reference: Pharmaceuticals 2018, 11, 75
DOI: 10.3390/ph11030075

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 US Food and Drug Administration-approved parenteral therapies with pediatric indications. 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 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.

Subject Areas

PEGylation; safety; pediatric; biologics; polyethylene glycol; excipient; conjugation; polysorbate; hemophilia; rurioctocog alfa pegol

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