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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.

What is seasonal flu?
The flu is a contagious respiratory illness caused by influenza type A or type B viruses. It can cause mild to severe illness and at times can be fatal. The best way to prevent this illness is by getting a flu vaccination (flu shot) each fall.1
 
Each year in the United States, seasonal flu imposes a heavy burden on society:1
  • About 5% to 20% of the population gets the flu
  • More than 200,000 people are hospitalized with flu complications
  • About 36,000 people die from flu complications
 
Common flu symptoms in adults and
young children1
 
In Adults
Children may also experience
Symptoms
  • Fever (usually high)
  • Headache
  • Extreme fatigue
  • Muscle aches
  • Dry cough
  • Sore throat
  • Stuffy nose
  • Vomiting
  • Diarrhea
Complications
  • Bacterial pneumonia
  • Dehydration
  • Worsening of chronic medical conditions (congestive heart failure, asthma, diabetes)
  • Sinus problems
  • Ear infections

Flu spreads easily1


Flu viruses spread in respiratory droplets caused by coughing and sneezing. The flu viruses usually spread from person-to-person, though sometimes people become infected by touching something with a flu virus on it and then touching their mouth or nose.
 
Most healthy adults may be able to infect others 1 day before symptoms develop and up to 5 days after becoming sick. That means that you can pass on the flu to someone else before you know you are sick, as well as while you are sick.
 
Now that you know a little more about seasonal flu, find out who is most at risk to get it.

 
FOOTNOTE
1. US Dept of Health and Human Services. Centers for Disease Control and Prevention Web site. Key facts about influenza and influenza vaccine. Available at: http://www.cdc.gov/avian/gen-info/facts.htm 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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