Alerts
Peramivir Injection – Emergency Use Authorization for H1N1 Influenza
October 26, 2009
The FDA has issued an Emergency Use Authorization for peramivir injection for the treatment of H1N1 influenza (formerly called swine flu) infection, in response to a request from the Centers for Disease Control and Prevention (CDC). Peramivir is an investigational neuraminidase inhibitor antiviral agent, which is not FDA-approved. The emergency use authorization allows for peramivir use in hospitalized adults and children with suspected or confirmed H1N1 infection who meet at least 1 of the following criteria:
- Oral or inhaled antiviral therapy has been tried with inadequate response,
- Administration by the IV route is desired because:
- Oral or inhaled administration of antivirals is expected to be undependable or is infeasible, or
- IV administration is desired for other reasons (only applies to adults).
Peramivir injection will be distributed by CDC, in response to a request from a licensed prescriber. The prescriber must complete a product request form (available at http://www.cdc.gov/h1n1flu/eua/MASTER%20Manual%20PERAMIVIR%20Request%20FormV2_rev25Oct09CDC.pdf), then fax the completed form to CDC at 770-488-7107 or 404-553-7508. CDC will review requests for peramivir injection and distribute product to hospitals. Once CDC approves use for a specific patient, CDC will distribute peramivir to the hospital within 24 hours of this decision.
Peramivir is given IV once daily for 5 – 10 days. Dosage adjustment is necessary in patients with renal dysfunction. The recommended adult dose is peramivir 600 mg/day IV, infused over 30 minutes (or no faster than 40 mg/minute). The pediatric dose is based on the patient’s age and weight, up to a maximum of 600 mg/day, as follows:
- Up to 30 days: 6 mg/kg/day
- 31 – 90 days: 8 mg/kg/day
- 91 – 180 days: 10 mg/kg/day
- 181 days – 5 years: 12 mg/kg/day
- 6 – 17 years: 10 mg/kg/day
Common side effects of peramivir include diarrhea, nausea, vomiting, and neutropenia. Because its safety has not been well-evaluated, mandatory reporting is required for selected adverse events and any medication errors. Such events must be reported to MedWatch within 7 calendar days of onset. Clinicians must also conduct follow-up evaluations related to these events, as requested by FDA or CDC. Reportable adverse events include death, neuropsychiatric reactions, renal effects, serious skin reactions, hypersensitivity reactions, severe IV site reactions, severe reactions related to IV administration, and other life-threatening events.
Additional information can be obtained at the following links:
- FDA Information
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm187814.htm - Press Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187813.htm - CDC Information Page:
http://www.cdc.gov/h1n1flu/eua/peramivir.htm - Recommendations:
http://www.cdc.gov/h1n1flu/EUA/peramivir_recommendations.htm - Product request form:
http://www.cdc.gov/h1n1flu/eua/MASTER%20Manual PERAMIVIR Request FormV2_rev25Oct09CDC.pdf - Peramivir Drug Information:
- Information for HealthCare Professionals:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm187710.htm - Healthcare Provider Information Sheet, with package insert information:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/UCM187811.pdf - Patient and Caregiver Information Sheet:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ UCM187799.pdf - Letter of Authorization for Emergency Use:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/UCM187800.pdf
Updated
October 26, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
