Clinicians Considering the Use of Peramivir IV

Clinicians Considering the Use of Peramivir IV

Currently there is no intravenous formulation of antiviral product approved by the U.S. Food and Drug Administration (FDA) for the treatment of hospitalized patients with influenza. Peramivir, a neuraminidase inhibitor, is an unapproved (investigational) antiviral drug available in an intravenous (IV) formulation. Peramivir IV is currently under development for treatment of acute influenza in patients who require hospitalization due to the severity of influenza virus infection. The efficacy and safety of Peramivir have not yet been established. The FDA has issued an Emergency Use Authorization (EUA) to allow the use of Peramivir IV to treat certain adult and pediatric patients with suspected or laboratory confirmed 2009 H1N1 virus infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology. The authorized use of Peramivir IV under EUA is subject to the scope, conditions, and terms of FDA-issued EUA.

Clinicians considering Peramivir under EUA must read and understand the content of the FDA-issued Emergency Use Authorization of Peramivir IV: Fact Sheet For Health Care Providers prior to initiating a request and must agree to comply with terms and conditions of authorized use of Peramivir per the FDA-issued EUA in order to successfully complete and transmit the request for this product.

Additionally, clinical studies of Peramivir IV in hospitalized patients are currently being conducted. Clinicians who wish to consider whether their patients would be appropriate for inclusion in these clinical studies, please refer to clinicaltrials.gov for more information on these trials.

If after reviewing these and other materials on CDC website, you have clinical questions relating to use of Peramivir, please contact CDC INFO at 1-800-232-4636, 24 hours a day, 7 days a week (For TTY, call 1-888-232-6348).

If after reviewing these materials, you would like to proceed with requesting Peramivir IV, click on the button below. If you have questions relating to emergency use authorizations, contact: EUA.OCET@fda.hhs.gov

Other Antiviral Treatment Options for Patients Hospitalized due to Complicated Influenza
Currently there is no FDA-approved intravenous formulation of antiviral product for the treatment of hospitalized patients with influenza. Oral Tamiflu® (oseltamivir) and inhalation Relenza® (zanamivir) are FDA-approved for the treatment of uncomplicated acute illness due to influenza. Use of these medications is authorized for emergency use for the treatment of hospitalized patients with 2009 H1N1 influenza under FDA-issued EUAs.

The FDA-issued EUA for Tamiflu® authorizes use of Tamiflu® for the treatment of patients hospitalized due to complicated influenza and in patients symptomatic for more than 2 days, including pediatric patients less than 1 year old. The authorized use of Tamiflu® is subject to the terms and conditions of the EUA. For more information on the Tamiflu® EUA, please see: www.cdc.gov/h1n1flu/eua/tamiflu.htm

The FDA-issued EUA for Relenza® authorized use of Relenza® for the treatment of patients hospitalized due to complicated influenza and in patients symptomatic for more than 2 days. The authorized use of Relenza® is subject to the terms and conditions of the EUA. For more information on the Relenza® EUA, please see: www.cdc.gov/h1n1flu/eua/relenza.htm

You will be required to acknowledge your compliance with the terms and conditions of the EUA in order to request Peramivir IV.


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Clinicians Considering the Use of Peramivir IV