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Quick, important information on influenza and TAMIFLU®
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Influenza Virus
Management of Influenza
In accordance with the CDC's Advisory Committee on Immunization Practices, the first option for reducing the
effect of influenza is through annual vaccination with either inactivated (i.e., killed virus) vaccine or
live attenuated influenza vaccine (LAIV). Both types of vaccine differ based on their route of
administration, administration guidelines, virus strains and approved age and risk groups.3
Vaccination is the First Line of Defense Against Influenza
The CDC recommends annual vaccination for the following groups:
- Children aged 6–59 months
- Women who will be pregnant during the influenza season
- Persons aged > 50 years
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Children and adolescents (aged 6 months-18 years) who are receiving long-term
aspirin therapy and, therefore, might be at risk for experiencing Reye Syndrome
after influenza infection
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Adults and children who have chronic disorders of the pulmonary or cardiovascular systems, including asthma
(hypertension is not considered a high-risk condition)
-
Adults and children who have required regular medical follow-up or hospitalization during the
preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction,
hemoglobinopathies, or immunodeficiency (including immunodeficiency caused by medications or by human
immunodeficiency virus)
-
Adults and children who have any condition (e.g., cognitive dysfunction, spinal cord injuries,
seizure disorders, or other neuromuscular disorders) that can compromise respiratory function or
the handling of respiratory secretions, or that can increase the risk for aspiration; Residents of nursing homes
and other chronic-care facilities that house persons of any age who have chronic medical conditions
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Persons who live with or care for persons at high risk for influenza-related complications,
including healthy household contacts and caregivers of children aged 0–59 months; and
- Healthcare workers 3
Limitations of Vaccines
-
Vaccine effectiveness can vary, since new strains of the influenza virus surface regularly. Therefore, influenza should not be ruled out in the differential diagnosis.
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17-59 years of age*: 70% to 90% effective
-
50-64 years of age*: 52% effective
-
58-104 years of age†: 17% to 53% effective
* Vaccine efficacy based on measurement of immune response.
† Vaccine efficacy based on measurement of antibody response.
The CDC Recommends Use of Neuraminidase Inhibitors for the Treatment
and Prevention of Flu During the 2006-2007 Influenza Season
-
Vaccination is the first line of defense against influenza. According to the CDC, antiviral
medications can also be effective at treating and preventing influenza 3
-
The CDC recommends the use of oseltamivir (TAMIFLU) or zanamivir if an antiviral medication is used for the treatment or prevention
of influenza 3
TAMIFLU Resistance Profile
- Study results in 1999 showed a 1.3% (4/301) level of resistance to TAMIFLU for adults and 8.6% (9/105) in pediatric patients aged 1 to 12 years 1
- In a study of TAMIFLU postexposure prophylaxis conducted in 277 households, no TAMIFLU-resistant variants were detected in treated index cases or contacts 8
- Insufficient information is available to fully characterize the risk of emergence of TAMIFLU resistance in clinical use
- Please see Important Safety Information
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Important Safety Information
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.
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