Influenza (Flu) Antiviral Drugs and Related Information -Tamiflu (oseltamivir phosphate)

Influenza (Flu) Antiviral Drugs and Related Information

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.




Introduction
Influenza Vaccine Information
Drug Information
Influenza Information from Other Web Sites
Contacts For More Information
Introduction

The term "influenza" refers to illness caused by influenza virus. This is commonly also called "flu", but many different illnesses cause "flu-like" systemic and respiratory symptoms such as fever, chills, aches and pains, cough, and sore throat. In addition, influenza itself can cause many different illness patterns, ranging from mild common cold symptoms to typical "flu" to life-threatening pneumonia and other complications, including secondary bacterial infections.

This web site contains links to several sources of general information about influenza. Because vaccination is the primary means of preventing and controlling influenza, links related to influenza vaccine are listed first, followed by links related to antiviral drugs that have been approved in the United States for influenza. After the vaccine and antiviral drug links, there is a list of web sites that provide additional influenza information from United States government agencies and the World Health Organization, and a list of contacts for further inquiries.

Information provided on this web site may change frequently, and should not be used as a substitute for individual evaluation by a health care provider, or as the primary means of diagnosing influenza or determining treatment.

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Influenza Vaccine Information
Influenza vaccine is the principal method of preventing and controlling influenza. The following links provide information on general uses of vaccines and on current supply issues.

Influenza Virus Vaccine. Information from Center for Biologics Evaluation and Research (CBER)
Seasonal Flu. Comprehensive flu information for consumers and healthcare professionals from the Centers for Disease Control and Prevention (CDC).
Influenza Vaccine: What you need to know. Consumer pamphlet from the CDC containing basic vaccine questions and answers.
Drug Information

Uncomplicated influenza gets better with or without treatment, but may cause substantial discomfort and limitation of activity before getting better. Complications of influenza can include bacterial infections, viral pneumonia, and cardiac and other organ system abnormalities. People with chronic medical conditions may have increased risk of complications when they get influenza. Many other diseases, including serious infections such as rapidly progressive bloodstream infections, may start with symptoms that resemble influenza and may need to be considered in treatment decisions. Rapid laboratory tests can help in detecting influenza but do not exclude the possibility of other illnesses or take the place of clinical evaluation.

Many people with uncomplicated influenza use over-the-counter medicines to help lessen their symptoms. Antiviral drugs available by prescription can also help to reduce the time it takes for symptoms to improve in uncomplicated illness caused by influenza virus. Recent increases in the number and promotion of antiviral drugs for influenza have increased interest in the role of specific antiviral drugs for this condition. Other products are sometimes promoted for prevention or treatment of influenza, but may not have been tested for their actual effects against influenza.

Complications of influenza, and other illnesses that resemble influenza, may require different treatment and may need urgent medical attention. Use of antiviral drugs does not eliminate the risk of complications, and some complications (as well as other medical conditions that could be confused with influenza) can be life-threatening. In addition, influenza viruses can become resistant to specific anti-influenza antiviral drugs, and all of the drugs have side effects. Therefore, if you have new symptoms during treatment, or your symptoms persist or get worse during treatment, you should see your health care provider.

There has been a lot of recent concern about "bird flu" infection and infections initially called "swine flu" and then called " H1N1" . These terms refer to a number of influenza viruses that occur in birds or that resemble some infections in pigs, and can sometimes cause infections in people. Some of the current influenza antiviral drugs are able to inhibit many of these viruses in the laboratory although it is not known exactly how much effect they might have against illness in people. More information and public health recommendations about these infections can be found at the CDC and WHO websites and the pandemicflu.gov website listed below under "Influenza Information from Other Web Sites."

Outbreaks of influenza occur every year and typically reach epidemic levels during some part of the season. If a new variety of influenza starts to be transmitted rapidly between people, it can cause extremely widespread illness known as a pandemic. Depending on the strain of influenza causing a pandemic, antiviral drugs may have varying levels of usefulness. The government is stockpiling antiviral drugs, and developing recommendations about their use, as part of pandemic preparedness efforts (see additional information at links below).

The following links lead to information such as trade names, package inserts, and other material related to the four antiviral drugs currently approved by FDA to treat acute, uncomplicated influenza. Two related drugs, amantadine (approved 1966; available as generic Amantadine Hydrochloride) and rimantadine (approved 1993; Trade Name Flumadine, also available as generic Rimantadine Hydrochloride), are approved for treatment and prevention of influenza A, but many strains of influenza have now become resistant to these drugs as noted in the 2006 CDC Health Alert. Two newer drugs, zanamivir (approved 1999; Trade Name Relenza; no approved generics) and oseltamivir phosphate (approved 1999; Trade Name Tamiflu; no approved generics), are approved for treatment of acute uncomplicated illness due to influenza A and B. Both zanamivir and oseltamivir are approved for preventive use. Approved ages, doses, and dosing instructions in children are different for each drug, so the individual package inserts should be checked for this information. The anti-influenza antiviral drugs are not a substitute for vaccine and are used only as an adjunct to vaccine in the control of influenza.

The antiviral drug information addresses side effects or adverse events that might be associated with each drug. Because some side effects can be serious and because viruses may become resistant when antiviral drugs are used indiscriminately, decisions on the use of these drugs should be based on individual evaluations of risk and benefit. FDA encourages reporting of serious adverse events (associated with these or any other drugs) to the MedWatch program to facilitate continued updating of risk/benefit information.

Amantadine Hydrochloride. Approval, review, and labeling information from Drugs@FDA.
Flumadine (rimantadine). Approval, review, and labeling information from Drugs@FDA.
Relenza (zanamivir). Approval, review, and labeling information from Drugs@FDA, plus consumer information.
Tamiflu (oseltamivir phosphate). Approval, review, and labeling information from Drugs@FDA, plus consumer information. (updated 11/13/2006)
CDC Recommends Against the Use of Amantadine and Rimantadine for the Treatment or Prophylaxis of Influenza in the United States During the 2005–06 Influenza Season. (1/14/2006)
CDC Interim Antiviral Guidance for 2008-09
Office of Generic Drugs - Statement on Expedited Review of Generic Drug Products for the Prophylaxis and Treatment of Illness Caused by Various Strains of the Influenza Virus. (10/18/2004)
Public Health Advisory: Safe and Appropriate Use of Influenza Drugs. (Issued 1/12/2000). Health professionals, especially prescribers, are reminded of important clinical decisions that need to be made when considering use of anti-viral drugs for signs and symptoms of influenza.
Emerging Viral Infections Information on approaches to drug development for antiviral drugs.
Draft Guidance for Industry, Influenza: Developing Drugs for Treatment and/or Prophylaxis
Electronic Orange Book This resource can be searched for holders of approved or discontinued marketing applications, especially for drugs that may have more than one source of generic preparations.
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Contacts for More Information
Information on availability of influenza vaccine:
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Communication, Training & Manufacturers Assistance
301-827-1800. Fax: 301-827-3843
octma@fda.hhs.gov

Information on drugs used to treat influenza:
Food and Drug Administration
Center for Drug Evaluation and Research
Drug Information Line
888-info-FDA or 301-827-4573. Fax: 301-827-4577
druginfo@fda.hhs.gov

Information on influenza prevention and control:
Centers for Disease Control and Prevention
Public Inquiries Office
800-311-3435 or 404-639-3311. Fax: 770-488-4995
inquiry@cdc.gov


-Influenza Information from Other Web Sites
2009 H1N1 (Swine) Flu Virus
FDA is working to address human infection with the 2009 H1N1 flu virus as part of a team led by the Department of Health and Human Services.
Centers for Disease Control and Prevention (CDC) Swine Influenza Web Site
Centers for Disease Control and Prevention (CDC) Swine Influenza Web Site
Avian Influenza (Bird Flu) - CDC
CDC: Influenza (Flu)
Comprehensive flu information for consumers and healthcare professionals from the CDC.
Cautions in Using Rapid Tests for Detecting Influenza A Viruses
Information about rapid influenza tests currently available in the U.S. market, their uses and limitations for detecting Influenza A viruses.
World Health Organization (WHO) - Influenza Information
WHO fact sheets, plus global surveillance and outbreak information.
National Institutes of Allergy and Infectious Diseases (NIAID) flu page
National Institutes of Allergy and Infectious Diseases (NIAID) flu page
National Vaccine Program Office - Pandemic Influenza
Information about influenza, pandemics, and the Pandemic Influenza Preparedness and Response Plan.
Flu.gov
U.S. government Web site for information on multiple topics related to influenza.
- Contact Us1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online

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