RAPIVAB Influenza Treatment Description
RAPIVAB (peramivir injection) is an influenza virus neuraminidase inhibitor.
Neuraminidase inhibitors interfere with the release of the influenza virus from infected host cells, a process that prevents infection of new host cells and thereby halts the spread of infection in the respiratory tract.
RAPIVAB Influenza Treatment Indication
RAPIVAB is indicated for treating acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days.
RAPIVAB Influenza Treatment Dosage
RAPIVAB (peramivir injection) is approved in the United States and is administered via an intravenous infusion for a minimum of 15 minutes at recommended doses of 600 mg/kg for adults and adolescents and 12 mg/kg for pediatric patients ages six months to 12 years.
RAPIVAB Influenza Treatment Clinical Trials
Clinical Trial NCT02369159: A Phase 3, Randomized, Open-Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics, and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute Uncomplicated Influenza
This study will evaluate the safety, pharmacokinetics, and effectiveness of a single dose of IV peramivir compared to a standard 5-day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza. Two-thirds of the participants will receive peramivir, while one third will receive oseltamivir.
Clinical Trial NCT00705406: A Phase II, Multicenter, Randomized, Placebo-Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
Clinical Trial NCT00419263: Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.
Peramivir is a neuraminidase inhibitor that was previously shown to be effective in the treatment of human experimental influenza using an oral formulation. Parenteral formulations of peramivir (for intramuscular and intravenous injection) entered clinical development at the time of this Phase 2 study.
A series of Phase 1 studies in human volunteers was completed that provided safety and pharmacokinetic results that supported the initiation of this Phase 2 multinational, randomized, double-mask study that compared the antiviral efficacy and safety of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza.
Because of the unique pharmacokinetic and pharmacodynamic properties of peramivir - a long terminal half-life in plasma and an extended duration of binding to the neuraminidase enzyme - subjects were randomized in a 1:1:1 ratio to receive a single dose of one of three treatments: peramivir 150 mg, peramivir 300 mg, and placebo.
The study drug was administered as one 2-mL intramuscular injection in each gluteal muscle (total of 4 mL, injected in divided doses). This multinational study was originally to be conducted at approximately 80 sites in the US and Canada. When enrollment during the North American influenza season of 2006-2007 did not achieve the target, the study was extended to sites in Australia, New Zealand, South Africa, and Hong Kong.