References

References

  1. TAMIFLU® (oseltamivir phosphate) Prescribing Information. Nutley, NJ: Roche Laboratories Inc.; August 2008.
  2. Centers for Disease Control and Prevention. Key facts about influenza and the influenza vaccine [CDC Web site]. August 30, 2006. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed December 15, 2006.
  3. Centers for Disease Control and Prevention. Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2006;55(RR-10):1-42.
  4. Centers for Disease Control and Prevention. Hoyert DL, Heron MP, Murphy SL, Kung HC. Deaths: Final data for 2003. Natl Vital Stat Rep. 2006;54:1-38.
  5. Montalto, NJ. An office-based approach to influenza: clinical diagnosis and laboratory testing. Am Fam Phys. 2003;67:111-118.
  6. Whitley RJ, Hayden FG, Reisinger KS, et al. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J. 2001;20:127-133.
  7. Poehling KA, Edwards KM, Weinberg GA, et al, for the New Vaccine Surveillance Network. The underrecognized burden of influenza in young children. N Engl J Med. 2006;355:31-40.
  8. 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.
  9. 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.
  10. Ward P, Small I, Smith J, Suter P, Dutkowski R. Oseltamivir (TAMIFLU®) and its potential for use in the event of an influenza pandemic. J Antimicrob Chemother. 2005;55(suppl 1):i5-i21.
  11. Welliver R, Monto AS, Carewicz O, et al, for the Oseltamivir Post Exposure Prophylaxis Investigator Group. Effectiveness of oseltamivir in preventing influenza in household contacts. A randomized clinical trial. JAMA. 2001;285:748-754.
  12. National Prescription Audit™ and Next Generation Prescription Services™, 1999-present. IMS Health; 2006.

Important Safety Information

Indications

TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients 1 year 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.

TAMIFLU is not a substitute for early and annual vaccination as recommended by the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP).

Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.

Safety Information

There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.

Treatment efficacy in subjects with chronic cardiac 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 at imminent risk of requiring hospitalization.

Efficacy of TAMIFLU has not been established in immunocompromised patients.

Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

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. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.

The most common adverse events reported >1% of patients treated with TAMIFLU and more commonly than in patients treated with placebo are:

  • Treatment of adult and pediatric patients - nausea, vomiting.
  • Prophylaxis of adult and pediatric patients - nausea, vomiting, abdominal pain.

Vaccination is considered the first line of defense against influenza.

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