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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.

How does seasonal flu differ from pandemic flu?
 
Seasonal Flu
Pandemic Flu
Outbreaks follow predictable seasonal patterns; occurs annually, usually in winter, in temperate climates Occurs rarely (three times in 20th century - last in 1968)
Usually some immunity built up from previous exposure No previous exposure; little or no preexisting immunity
Healthy adults usually not at risk for serious complications; the very young, the elderly, and those with certain underlying health conditions at increased risk for serious complications Healthy people may be at increased risk for serious complications
Health systems can usually meet public and patient needs Health systems may be overwhelmed
Vaccine developed based on known flu strains and available for annual flu season Vaccine probably would not be available in the early stages of a pandemic
Adequate supplies of antivirals are usually available Effective antivirals may be in limited supply
Average US deaths approximately 36,000/yr Number of deaths could be high
Symptoms: fever, cough, runny nose, muscle pain. Deaths often caused by complications, such as pneumonia Symptoms may be more severe and complications more frequent
Generally causes modest impact on society (e.g., some school closing, encouraging people who are sick to stay home) May cause major impact on society (e.g., widespread restrictions on travel, closings of schools and businesses, cancellation of large public gatherings)
Manageable impact on domestic and world economy Potential for severe impact on domestic and world economy

 
Find out who is most at risk for a pandemic flu.

 
FOOTNOTE
7.US Dept of Health and Human Services. Flu Information. Available at: http://www.pandemicflu.gov/season_or_pandemic.html. Accessed April 13, 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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