The pharmacokinetic and safety profiles of zanamivir after single and repeat intravenous administration in healthy Japanese males

Abstract

Single and 5-day BID repeat dosing of 600 mg were safely administered in Japanese healthy subjects. The pharmacokinetic profile of zanamivir after intravenous administration was consistent with previously reported findings in non-Japanese subjects.

Characteristics and mortality of severe influenza cases treated with parenteral aqueous zanamivir, United Kingdom, October 2009 to January 2011

“…Most cases had received prior treatment with oseltamivir, a drug which is well absorbed and has the same mode of action as zanamivir. Zanamivir has previously been reported as well tolerated, but most published previous evaluation has been of the inhaled powder formulation, which leads to low levels of systemic absorption, or in healthy volunteers . Intravenous administration of aqueous zanamivir results in higher systemic absorption which could result in more frequent or severe adverse events.…”

“…Zanamivir has previously been reported as well tolerated, but most published previous evaluation has been of the inhaled powder formulation, which leads to low levels of systemic absorption, or in healthy volunteers. 3,18 Intravenous administration of aqueous zanamivir results in higher systemic absorption 19 In the event of a future potential pandemic, information on novel treatments needs to be collected and analysed in real time in order to inform the response to a pandemic, using randomised, controlled trials where possible. Future evaluations of investigational products during influenza pandemics will require standardised collection of high-quality data to inform the evidence base, ideally planned in advance allowing for adequate staff training, and undertaken prospectively; a challenge that is currently being addressed by the PREPARE 24 and ISARIC 25 projects.…”