Peramivir Fact Sheet for Health Care Providers

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EMERGENCY USE AUTHORIZATION OF PERAMIVIR IV FACT SHEET FOR HEALTH CARE PROVIDERS

To request Peramivir IV under Emergency Use Authorization (EUA) go to: www.cdc.gov/h1n1flu/eua.

FDA has authorized the emergency use of Peramivir IV under EUA based upon its conclusion that the statutory criteria have been met. Even though there are a number of limitations to the safety and efficacy data available at this stage of Peramivir's development and the data reported are preliminary in nature, based upon the totality of scientific evidence available, it is reasonable to believe that Peramivir IV may be effective in certain patients as specified in this Fact Sheet.

The health care provider should communicate to the patient or parents/caregiver information consistent with this Fact Sheet and/or the Fact Sheet for Patients and Parents/Caregivers prior to the patient receiving Peramivir IV, including:

1. The Secretary of HHS has authorized the emergency use of Peramivir IV, which is not an FDA approved drug.
2. The patient has the option to accept or refuse Peramivir IV
3. The significant known and potential risks and benefits of Peramivir IV and the extent to which such risks and benefits are unknown;
4. Information on available alternative treatments and the risks and benefits of those alternatives.

HIGHLIGHTS

This section provides a brief introduction to selected information on use of Peramivir IV under EUA. Health care providers must read the full Fact Sheet for Health Care Providers that follows.

• Peramivir, a neuraminidase inhibitor, is an intravenous (IV) drug authorized for emergency use for the treatment of certain hospitalized patients with known or suspected 2009 H1N1 influenza.
• Peramivir IV is an unapproved drug and is still being evaluated in phase 3 clinical trials. Limited phase 2 and 3 safety and efficacy data for Peramivir IV are available, but not sufficient to constitute an adequate basis to establish safety and efficacy that is required for full marketing approval. The data are sufficient to allow approval for emergency use of Peramivir IV in certain patients as described herein.
• The standard adult dose of Peramivir is 600 mg once a day, administered intravenously for 5 to 10 days.
• Commonly reported adverse events in Peramivir IV clinical trials were diarrhea, nausea, vomiting, and neutropenia. Additional adverse events associated with the drug, some of which may be serious, may become apparent with more widespread use.
• Although not observed in clinical trial data available to date Peramivir IV may be associated with rare cases of anaphylaxis and serious skin reactions and a variety of neurologic and behavioral symptoms that have been reported with other neuraminidase inhibitors.