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Pandemic Planning Toolkit A resource to assist your organization in preparing for pandemic influenza

TAMIFLU® (oseltamivir phosphate) has been studied only in strains of influenza that were circulating at the time. The magnitude of effect of TAMIFLU in treating and preventing novel strains of influenza, such as those that may be involved in a pandemic, cannot be predicted.

Who is most at risk for a pandemic flu?

Pandemic flu

A flu pandemic occurs when a new flu virus against which the human population has no immunity appears. This results in several, simultaneous epidemics worldwide with enormous numbers of infections and deaths.
 
With the increase in global transport and communications, as well as urbanization and overcrowded conditions, epidemics due to the new flu virus are likely to quickly take hold around the world.5

Pandemic flu doesn't discriminate.

In the worst pandemic of all time, the "Spanish flu" of 1918, as many as 50 million people perished worldwide. This pandemic caused most deaths in young and healthy persons in the age range of 15 to 35 years. In a complete reversal of previous patterns, 99% of deaths occurred in people younger than 65 years.8 The "milder" flu pandemic that occurred during 1968 and 1969 killed 1 million people across the globe.9
 
Find out what the likelihood is of a flu pandemic.
FOOTNOTE
5. Stimola AN. Avian Influenza, or "Bird Flu": What You Need to Know. New York, NY: American Council of Science and Health; 2006.
8. Kamps BS, Hoffmann C, Preiser W, eds. Influenza report. Available at: http://www.influenzareport.com/ir/overview.htm. Accessed April 13, 2006.
9. World Health Organization Web site. Avian influenza: assessing the pandemic threat. January 2005. Available at: http://www.who.int/csr/disease/influenza/H5N1-9reduit.pdf. Accessed April 18, 2006.
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.

Please see TAMIFLU full Prescribing Information for additional safety information.
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