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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 role will vaccines play?
Vaccination is one of the most effective ways to minimize suffering and death due to seasonal influenza.29 In fact, vaccination is universally regarded as the most important medical intervention for preventing seasonal influenza and reducing its health consequences.

Flu Vaccines

Flu vaccination is recommended for people who are at high risk for complications if they contract flu. It is also recommended for people aged 50 to 64, since one third of individuals in this age range have medical conditions that place them at increased risk for complications of flu. Flu vaccination is also recommended for those who will be in close contact with others at high risk for complications of flu.
 
A Flu vaccination is not recommended for the following:
  • people younger than six months old
  • individuals with severe allergies to chicken eggs
  • those who have had a severe reaction to flu vaccine in the past
  • or anyone who has ever developed Guillain-Barré syndrome

Vaccines in a Pandemic

In a pandemic, it could take several months to develop an effective vaccine. Presently, there is no commercially available vaccine to protect humans against potential pandemic strains. However, research studies to test potential vaccines to protect humans against pandemic flu are under way.22
 
For more information about the vaccine development process, visit the National Institutes of Health Web site - http://www.nih.gov.
 
Learn about what medical treatments are available to you.

 
FOOTNOTE
22. US Dept of Health and Human Services. Pandemic planning update: a report from Secretary Michael O. Leavitt (2006). Available at: http://www.pandemicflu.gov/plan/pdf/panflu20060313.pdf. Accessed April 13, 2006.
29. Department of Health and Human Services. Centers of Disease Control and Prevention. Supplement 6: vaccine distribution and use. Available at: http://www.hhs.gov/pandemicflu/plan/sup6.html#vacc. Accessed April 26, 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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