Human Research Protection Program

EUA for use of peramivir IV for H1N1 2009

In a letter dated October 23rd, 2009, The Food and Drug Administration (FDA)/Department of Health and Human Services (DHHS)

approved the Centers for Disease Control (CDC) request for an Emergency Use Authorization for the unapproved drug peramivir IV for the treatment of H1N1 virus 2009.

This EUA authorizes CLINICAL use of peramivir -- without IRB oversight -- under the following conditions:

1. For the treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to non subtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology.  Specifically the peramivir product is authorized only for the following patients who have been admitted to a hospital and are under the care or consultation of a license clinician (skilled in the diagnosis and management of patients with potentially life threatening illness and the ability to recognize and manage medication-related adverse events):
   
   1. Adult patients for whom therapy with an IV agent is clinically appropriate, based on one or more of the following reasons:
      
      • Patient is not responding to either oral or inhaled antiviral therapy, or
      • Drug delivery by a route other than IV (e.g. enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or  feasible, or
      • The clinician judges IV therapy to be appropriate due to other circumstances

The Fact Sheet includes some precautions regarding the use of peramivir. For example, patients with known or suspected renal insufficiencies must have creatinine clearance determined prior to peramivir IV dose calculation and first administration. Another example is that patients with severe allergies to similar drugs (zanamivir or oseltamivir) should not receive peramivir IV. The Fact Sheet also spells out some procedural requirements for the use of peramivir under this EUA.  The clinician must document use of peramivir in the medical chart and must document he/she provided patients, parents and/or caregivers with the approved fact sheet outlining alternatives, and informing them that peramivir is an unapproved drug authorized for use in an emergency use authorization.

It is critical that clinicians know and follow these guidelines. Any exception to the guidelines (clinical profile of patient, different route of drug administration, failure to make required chart documentation or failure to document that patient was informed the drug is UNAPPROVED and being used under EMERGENCY USE AUTHORIZATION) invalidates the authorization, and requires that the clinician apply to the IRB for prior approval.

If you have any questions, please feel free to contact Dr. Clark (dclark@mcw.eduor 414-456-8422) or Kathryn Gaudreau (kgaudrea@mcw.eduor 414-456-8337).