Peramivir: an intravenous neuraminidase inhibitor for the treatment of 2009 H1N1 influenza.
OBJECTIVE
To review the efficacy and safety of peramivir, an unapproved neuraminidase inhibitor recently granted an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) for the treatment of 2009 H1N1 influenza in select patients.


METHODS
Literature was accessed via MEDLINE (1950-April 2010) using the search terms peramivir, BCX-1812, RWJ 270201, influenza H1N1, swine influenza, and neuraminidase inhibitors. The manufacturer of peramivir, BioCryst Pharmaceuticals, was contacted for unpublished data and information presented at recent scientific meetings. Information was obtained from the Centers for Disease Control and Prevention (CDC) and FDA Web sites. The mandatory requirements for the EUA for peramivir were also consulted.


METHODS
Available English-language literature was reviewed and selected based on relevance, as was information from the CDC, FDA, and the drug manufacturer.


RESULTS
The 2009 H1N1 influenza pandemic has necessitated the selective use of intravenous peramivir, an unapproved neuraminidase inhibitor. Intravenous peramivir has been studied in 4 clinical trials, 2 of which compared the drug to oseltamivir. Dose adjustments are required in pediatric patients and in those with impaired renal function. Clinicians wishing to use peramivir must request authorization from the CDC to confirm patient characteristics warranting its use and to verify the prescriber's understanding of dosing considerations and unapproved status.


CONCLUSIONS
Peramivir has shown efficacy for the treatment of 2009 H1N1 influenza; however, it has yet to receive FDA approval. Peramivir is used in hospitalized adult and pediatric patients with suspected or laboratory-confirmed 2009 H1N1 influenza meeting specific criteria, including those unable to receive inhaled or oral neuraminidase inhibitors, those who have not responded to other neuraminidase inhibitors, or when drug delivery by a route other than intravenous is not feasible.
Mancuso
Carissa E
CE
Department of Pharmacy Practice, College of Pharmacy, University of Illinois at Chicago, Chicago, IL 60612, USA. cmancuso@uic.edu
Gabay
Michael P
MP
Steinke
Leah M
LM
Vanosdol
Sherilyn J
SJ
D000146:Acids, Carbocyclic; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D003517:Cyclopentanes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D006146:Guanidines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000302:isolation & purification; D007251:Influenza, Human / Q000188:drug therapy* / Q000821:virology; D009439:Neuraminidase / Q000037:antagonists & inhibitors
D000146:Acids, Carbocyclic; D000998:Antiviral Agents; D003517:Cyclopentanes; D006146:Guanidines; D009439:Neuraminidase; C414210:peramivir