FDA Video: Emergency Use of Peramivir to Treat H1N1

FDA has authorized the emergency use of the investigational antiviral drug peramivir for certain adults and children hospitalized with confirmed or suspected 2009 H1N1 influenza. This includes patients who have an influenza A virus that is non-subtypeable and is suspected to be 2009 H1N1 based on cases in the community.

Peramivir, which is administered intravenously, is in the same drug class as Tamiflu and Relenza. Peramivir is authorized only under certain circumstances: when the patient is not responding to either oral or inhaled antiviral therapy, when other routes of drug administration are not expected to be dependable or feasible, or, in the case of adult patients, when the clinician judges that IV therapy is appropriate for other reasons.

Peramivir is not authorized to prevent influenza, to treat seasonal influenza, or to treat acute, uncomplicated 2009 H1N1 infection. Also, it should not be used in patients with severe allergies to Tamiflu (oseltamivir phosphate) or Relenza (zanamivir), or those who've shown resistance to Tamiflu.

Only CDC is authorized to distribute peramivir. Physicians who want to use it must apply through CDC's Peramivir IV Electronic Request System. Once the decision is made to ship the drug, it may take up to 24 hours to reach the hospital.

Because peramivir is an unapproved drug with limited safety data, health care providers or their designees are required to report certain adverse events and all medication errors associated with peramivir to FDA's MedWatch program. This must be done within 7 calendar days of the onset of the adverse event.