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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 could TAMIFLU play in a pandemic?

TAMIFLU to play dual role: prevention and treatment

The antiviral TAMIFLU could play two principal roles in the management of seasonal flu:
  • Prophylaxis - aimed at decreasing the likelihood of developing flu
  • Treatment - aimed at reducing the duration of flu by 1.3 days
Research has demonstrated the effectiveness of antivirals when used for both purposes. When used for treatment purposes, these drugs need to be administered within 48 hours after the onset of symptoms.22a

Tamiflu has been studied only in strains of the influenza virus that were circulating at the given time.  The magnitude of effect of Tamiflu in treating and preventing novel strains of influenza cannot predicted.

The Centers for Disease Control, along with an interagency working group with representatives from State, local and tribal public health agencies, drafted guidance on antiviral use strategies and stockpiling. The working group recommends the following strategies and settings for antiviral use:22a
  • Containing or suppressing initial pandemic outbreaks overseas and in the U.S. with treatment and post-exposure prophylaxis (PEP) among individuals identified as exposed to pandemic influenza and/or geographically targeted prophylaxis for geographic areas where exposure is thought likely to occur;


  • Reducing introduction of infection into the United States early in an influenza pandemic by post-exposure prophylaxis of exposed travelers as part of a risk-based policy at U.S. borders;


  • Treatment of persons with pandemic illness who present for care early during their illness and would benefit from such treatment;


  • Prophylaxis of critical health care workers, emergency service personnel, and workers with unique roles maintaining critical infrastructures for the duration of community outbreaks;


  • Post-exposure prophylaxis of household contacts of persons with influenza illness as a component of community mitigation

  • Post-exposure prophylaxis of workers in the health care sector with limited patient contact, of persons with compromised immune systems who are unable to be protected by vaccination, and of persons living in closed settings such as nursing homes and prisons if a pandemic outbreak occurs at that facility.

Expert recommendations for pandemic flu management 30

  1. Recent studies based on mathematical modeling suggest that antivirals could be used prophylactically near the start of a pandemic to reduce the risk that a fully transmissible virus will emerge (or at least delay its spread internationally), thus gaining time to augment vaccine supplies.

    This research has not been conducted in patients. Results are not based on a clinical study, but on mathematical modeling, which has significant limitations.

  2. The World Health Organization (WHO) recommends TAMIFLU for the prevention of pandemic influenza disease in household contacts. This recommendation is based on the effectiveness of TAMIFLU in preventing ordinary influenza in healthy and elderly patients and children ages 1 year and older. 31

Experts look to neuraminidase inhibitors for pandemic flu

  • TAMIFLU and Relenza are antivirals that belong to a drug class known as neuraminidase inhibitors. In laboratory studies, the neuraminidase inhibitors have been shown to reduce the duration of illness caused by seasonal influenza.34 The efficacy of the neuraminidase inhibitors depends on their administration within 48 hours after symptom onset. Studies are currently underway to examine the efficacy of TAMIFLU against potential pandemic strains of influenza.32
  • Another class of antiviral drugs, the M2 inhibitors amantadine and rimantadine, could potentially be used against pandemic influenza, but resistance to these drugs may develop.35
     
    -HHS Pandemic Plan

 
For more information about Tamiflu resistance, please see What is the TAMIFLU resistance profile?

 
FOOTNOTE
22a Centers for Disease Control (CDC), Proposed Guidance on
Antivirals Drug Use Strategies during an Influenza Pandemic,
November 8, 2007; Available at: http://www.businessgrouphealth.org/benefitstopics/topics/avianfludocs/110607_
antiviraldrugusestrategiesfedguidance.pdf
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.
30. US Dept of Health and Human Services. Centers for Disease Control and Prevention Web site. Interim Guidance for Protection of Persons Involved in U.S. Avian Influenza Outbreak Disease Control and Eradication Activities. Available at: http://www.cdc.gov/flu/avian/professional/protect-guid.htm. Accessed April 24, 2006
31. World Health Organization Web site. Advice on use of oseltamivir. Available at: http://www.who.int/csr/disease/avian_influenza/guidelines/-
useofoseltamivir2006_03_17A.pdf. Accessed May 16, 2006.
32. World Health Organization Website. Antiviral drugs: their role during a pandemic. November 2005. Available at: http://www.who.int/CSR/disease/avian_influenza/antivirals2005_11_3/en/.
33. Data on file. NDC #. Hoffmann-La Roche, Nutley NJ.
34. Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and safety of the oral neauraminidise inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. JAMA. 2000;28: 1016-1024.
35. US Dept of Health and Human Services. Supplement 7 Antiviral Drug Distribution and Use. Available at: http://www.hhs.gov/ pandemicflu/plan/sup7.html#5. Accessed April 19, 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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