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Influenza (Flu) Antiviral Drugs and Related Information
2009 H1N1 Flu Virus Update: 5/20/2009
FDA Approved Drugs for Influenza
Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the two FDA-approved influenza antiviral drugs that are recommended by CDC for use against the 2009 H1N1 influenza virus. The prescribing information for both products is provided below, as well as the Emergency Use Authorizations (EUA’s) and fact sheets for both drugs.
For comprehensive information from FDA, please go to the 2009 H1N1 Flu Virus (Swine Flu) Information page.
Relenza
Relenza Letter for Emergency Use Authorization
Relenza Healthcare Provider Fact Sheet
Relenza Patient Fact Sheet
Relenza Prescribing Information
Tamiflu
Update:Tamiflu Letter for Emergency Use Authorization
Update:Tamiflu Healthcare Provider Fact Sheet
Update:Tamiflu Patient Fact Sheet
Tamiflu Prescribing Information
Tamiflu Emergency Dosing Recommendations for Treatment and Prophylaxis of Influenza in Pediatric Patients less than 1 year old
Tamiflu Technical Review Document for H1N1 Influenza A
Emergency Compounding by Pharmacists of an Oral Suspension from Tamiflu Capsules
Stockpiles and commercial supplies of Tamilflu oral suspension are limited. FDA would like to remind healthcare providers and pharmacists of the FDA-approved Instructions for the emergency compounding of an oral suspension from Tamiflu capsules. These instructions provide for an alternative oral suspension when commercially manufactured oral suspension formulation is not readily available. The instructions can be found in the DOSAGE AND ADMINISTRATION section of the Tamiflu package insert under a subheader titled: Emergency Compounding of an Oral Suspension from TAMIFLU Capsules (Final Concentration 15 mg/mL)."
Stockpiled Antivirals at or Nearing Expiration
All companies, U.S. states and localities, and other organizations with Tamiflu and Relenza that are approaching, or past, the labeled expiration date, are urged to consider keeping it while the U.S. Department of Health and Human Services evaluates options, including those that may allow for their use if needed during this 2009 H1N1 flu virus outbreak.
If the stockpiling entity decides to retain expired or soon-to-expire Tamiflu and Relenza, it should be maintained and monitored under the product’s labeled storage conditions provided below.
These organizations are also urged to contact the FDA’s Emergency Operations Center with information on how much Tamiflu and Relenza in their stockpiles is at or approaching expiration.
Relenza Prescribing Information
Tamiflu Prescribing Information
Storage of Tamiflu (oseltamivir phosphate)
Tamiflu should be stored at controlled room temperature. The United States Pharmacopeia (USP) defines controlled room temperature as a temperature that is maintained by thermostat and is between 20 and 25˚C (68 to 77˚ F).
Under the Emergency Use Authorization (EUA) for Tamiflu, the storage requirements for Tamiflu held in public health authority stockpiles may be waived for a maximum of 90 days (consecutive or non-consecutive) from the date of shipment to the public health authority. This waiver is limited in that Tamiflu may be stored with temperature excursions in excess of 40°C (104˚F) for a total cumulative period of 14 days (consecutive or non-consecutive) within the 90-day period. Other temperature excursions that are outside of the labeled temperature storage conditions are permitted within the 90-day period provided they do not exceed 40˚C (104˚ F).
Tamiflu Lots Whose Expiration Date Has Been Extended
Four lots (batches) of Tamiflu for Oral Suspension were tested in the federal government’s Shelf Life Extension Program (SLEP)1. FDA has determined that the data from scientific testing supported the extension of the expiration dates for these four lots of Tamiflu.
The following table lists the lot numbers of Tamiflu Oral Suspension that have passed SLEP testing along with their original expiration dates and extended expiration dates:
Tamiflu for Oral Suspension
Lot number
Manufacturer’s original expiry date
FDA’s extended expiry date
B1184
June 30, 2009
May 31, 2011
B1185
June 30, 2009
May 31, 2011
B1186
June 30, 2009
May 31, 2011
B1187
June 30, 2009
May 31, 2011
The U.S. Department of Health and Human Services continues to evaluate options for antiviral drugs that are approaching, or past, the labeled expiration date. See “Stockpiled Antivirals at or Nearing Expiration”.
1 Certain antiviral medications that are at or nearing their expiration date may be tested under the federal government’s Shelf-Life Extension Program (SLEP). Under SLEP, FDA conducts scientific testing to see if specific lots of TAMIFLU can be used beyond the expiration dates originally printed on the label by the manufacturer. If the product passes testing, FDA determines that the shelf life of the product can be extended beyond the expiration dates originally printed on the label.
Fraudulent H1N1 Influenza Products
FDA is concerned that there may be websites selling products that claim to prevent or cure the H1N1 influenza virus. If you suspect that a website may be offering fraudulent H1N1 influenza products for sale please visit: Report Suspected Fraudulent Products.
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm
