Peramivir Fact Sheet for Health Care Providers
EMERGENCY USE AUTHORIZATION OF PERAMIVIR IV FACT SHEET FOR HEALTH CARE PROVIDERS
- Peramivir Injection 200 mg/20mL (10 mg/mL) is an Unapproved Product
- Mandatory Requirements for Peramivir IV Administration Under Emergency Use Authorization (EUA)
- Other Considerations Prior to Peramivir IV Use
- Authorized Use
- Dosage and Administration
- Warnings and Precautions
- Drug Interactions
- Clinical Pharmacology
- How Supplied
- Product Description
- Patient Information
The Secretary of the Department of Health and Human Services (HHS) has declared the rapid and extensive incidence of 2009 HIN1 infection a public health emergency that justifies the emergency use of certain drugs to treat 2009 H1N1 influenza. In response to this emergency, the Food and Drug Administration (FDA) has authorized the use of the unapproved drug, Peramivir IV, to treat certain adult and pediatric patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology.
Do not use Peramivir IV for the treatment of seasonal influenza A or B virus infections, for outpatients with acute uncomplicated 2009 H1N1 virus infection or for pre- or post-exposure chemoprophylaxis (prevention) of influenza.
The prescribing health care provider and/or their designee is/are responsible for mandatory FDA MedWatch reporting of all medication errors and selected adverse events occurring during Peramivir IV treatment within 7 calendar days from the onset of the event. See the Adverse Reactions and Medication Errors section below for details on the required FDA MedWatch reporting.
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:
- The Secretary of HHS has authorized the emergency use of Peramivir IV, which is not an FDA approved drug.
- The patient has the option to accept or refuse Peramivir IV
- The significant known and potential risks and benefits of Peramivir IV and the extent to which such risks and benefits are unknown;
- Information on available alternative treatments and the risks and benefits of those alternatives.
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.
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