References

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  2. Centers for Disease Control and Prevention. Seasonal influenza. http://www.cdc.gov/flu/about/qa/disease.htm. Accessed July 6, 2012.
  3. Centers for Disease Control and Prevention. The influenza (flu) viruses. http://www.cdc.gov/flu/about/viruses/index.htm. Accessed July 22, 2010.
  4. Centers for Disease Control and Prevention. Flu symptoms & severity. http://www.cdc.gov/flu/about/disease/symptoms.htm. Accessed July 22, 2010.
  5. Centers for Disease Control and Prevention. People at high risk of developing flu-related complications. http://www.cdc.gov/flu/about/disease/high_risk.htm. Accessed July 22, 2010.
  6. Centers for Disease Control and Prevention. Updated CDC estimates of 2009 H1N1 influenza cases, hospitalizations and deaths in the United States, April 2009-April 10, 2010. http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm. Accessed July 22, 2010.
  7. Centers for Disease Control and Prevention. Flu View. 2008-2009 influenza season week 12 ending March 28, 2009. http://www.cdc.gov/flu/weekly/weeklyarchives2008-2009/weekly12.htm. Accessed July 22, 2010.
  8. Whitley RJ, Hayden FG, Reisinger KS, et al. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J. 2001;20:127-133.
  9. Poehling KA, Edwards KM, Weinberg GA, et al; New Vaccine Surveillance Network. The underrecognized burden of influenza in young children. N Engl J Med. 2006;355:31-40.
  10. Centers for Disease Control and Prevention. Role of laboratory diagnosis of influenza. http://www.cdc.gov/flu/professionals/diagnosis/labrole.htm. Accessed July 22, 2010.
  11. Centers for Disease Control and Prevention. Interim results: influenza A (H1N1) 2009 monovalent vaccination coverage — United States, October - December 2009. MMWR Morb Mortal Wkly Rep. January 22, 2010; 59:44 - 48.
  12. Centers for Disease Control and Prevention. ACIP recommendations: introduction and biology of influenza. http://www.cdc.gov/flu/professionals/acip/background.htm. Accessed July 22, 2010.
  13. Centers for Disease Control and Prevention. Updated interim recommendations for the use of antiviral medications in the treatment and prevention of influenza for the 2009-2010 season. http://www.cdc.gov/h1n1flu/recommendations.htm. Accessed June 28, 2012.
  14. Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. JAMA. 2000;283:1016-1024.
  15. Data on file, Genentech USA, Inc.
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  17. National Institute of Allergy and Infectious Diseases. Is it a cold or the flu? http://www.niaid.nih.gov/topics/Flu/Documents/sick.pdf. Accessed August 3, 2010.
  18. Atkinson W, Hamborsky J, McIntyre L, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 11th ed. Washington, DC: Public Health Foundation; 2009:135-154. http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm. Accessed June 25, 2010.
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  22. Welliver R, Monto A, Carewicz O, et al. Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA. 2001;285(6):748-754.
  23. Hayden FG, Belshe R, Villanueva C, et al. Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis. J Infect Dis. 2004;189:440-449.
  24. Centers for Disease Control and Prevention. Vaccine selection for the 2011-2012 and 2012-2013 influenza seasons: questions & answers. http://www.cdc.gov/flu/about/qa/vaccine-selection.htm. Accessed June 28, 2012.
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  33. American Academy of Pediatrics. Policy Statement — Recommendations for Prevention and Control of Influenza in Children, 2011-2012. Committee on Infectious Diseases. Pediatrics; originally published online September 2, 2011. http://pediatrics.aapublications.org/content/early/2011/08/30/peds.2011-2295. Accessed September 7, 2011.
  34. Centers for Disease Control and Prevention. Interim estimates of cumulative influenza vaccination coverage for 2010-11 season — United States, end of February 2011. http://www.cdc.gov/flu/professionals/vaccination/reporti1011/reportII/. Accessed July 19, 2011.
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  36. US Census Bureau. USPOP Clock Projection. 2011. http://www.census.gov/population/www/popclockus.html. Accessed June 20, 2012.
  37. Fiore AE, Fry A, Shay D, Gubareva L, Bresse JS, Uyeki TM; Centers for Disease Control and Prevention. Antiviral agents for the treatment and chemoprophylaxis of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011;60(RR01):1-24. http://www.cdc.gov/h1n1flu/recommendations.htm. Accessed June 28, 2012.
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Did you know?

The CDC recommends antivirals in addition to yearly vaccination and preventive measures as part of an effective influenza management plan.30, 31

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Indications and Limitations of Use

TAMIFLU is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days.

TAMIFLU is also indicated for the prophylaxis of influenza in patients 1 year and older.

  • Efficacy of TAMIFLU in patients who begin treatment after 48 hours of symptoms has not been established.
  • TAMIFLU is not a substitute for early and annual vaccination as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
  • There is no evidence for efficacy of TAMIFLU in any illness caused by agents other than influenza virus types A and B.
  • Influenza viruses change over time. Emergence of resistant mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.
Important Safety Information

Severe allergic reactions

  • TAMIFLU is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of TAMIFLU.
  • In postmarketing experience, cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme, have been reported with TAMIFLU. TAMIFLU should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected.

Neurologic symptoms

  • Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
  • There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving TAMIFLU. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on TAMIFLU usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of TAMIFLU to these events has not been established. Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient.

Bacterial infections

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. TAMIFLU has not been shown to prevent such complications.

Limitations of populations studied

  • Efficacy of TAMIFLU in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization.
  • Efficacy of TAMIFLU for treatment or prophylaxis of influenza has not been established in immunocompromised patients.
  • Safety and efficacy of TAMIFLU for treatment of influenza in pediatric patients less than 2 weeks of age have not been established.
  • Safety and efficacy of TAMIFLU for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age.

Concurrent use with live attenuated influenza vaccine

  • The concurrent use of TAMIFLU with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of TAMIFLU, unless medically indicated.

Most common adverse reactions

  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of pediatric subjects aged 1 year and above, with vomiting, diarrhea, and diaper rash being the most frequently reported adverse reactions.
  • Adverse events that occurred more frequently in patients treated with TAMIFLU than in patients taking placebo and occurred in ≥2% of patients were (TAMIFLU %, placebo %):
    • Treatment in adults — nausea (10%, 6%), vomiting (9%, 3%).
    • Treatment in pediatrics — vomiting (15%, 9%), abdominal pain (5%, 4%), ear disorder (2%, 1%).
    • Prophylaxis of adults — nausea (7%, 3%), diarrhea (3%, 2%), vomiting (2%, 1%), abdominal pain (2%, 1%).
    • Prophylaxis of pediatrics — vomiting (10%, 2%), abdominal pain (3%, 0%), nausea (4%, 1%).

Please see the TAMIFLU full Prescribing Information for complete safety information.


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