TAMIFLU for Treatment of Influenza

Treatment with TAMIFLU Significantly Reduces the Duration of Influenza

TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days. TAMIFLU is indicated for prophylaxis of influenza in patients 1 year and older. TAMIFLU is not a substitute for early and annual influenza vaccination. ¹

Treat Influenza in Adults

TAMIFLU Significantly Reduces Duration of Illness by 1.3 days (30%) Compared with Placebo in Adults 18 to 65 Years Old ⁹

TAMIFLU significantly reduced flu duration by 1.3 days (30%) versus placebo (P<0.001)⁹
Symptom relief was defined as the first 24-hour period in which all influenza symptoms were scored as mild or none ⁹

*A randomized, placebo-controlled, double-blind study conducted January through March 1998 that included 629 healthy, non-immunized adults aged 18-65 years. The primary efficacy endpoint was time to resolution of illness, defined as time from study-drug initiation to time of alleviation of symptoms among individuals with influenza infection (374 of the subjects were influenza infected). ⁹

Treat Influenza in Children

TAMIFLU Significantly Reduces Duration of Illness by 1.5 Days (26%) Compared with Placebo in Children 1 to 12 Years Old (P<0.0001) ⁶

Primary efficacy endpoint was the time to resolution of illness, including mild/absent cough and mild/absent coryza, return to normal activity and euthermia (N=452)⁶
In children, TAMIFLU reduces median duration of fever by 25 hours ⁶

A randomized, double-blind, placebo-controlled study in which 695 children aged 1 to 12 years with fever ≥100°F (≥38°C) and a history of cough or coryza <48 h duration received oseltamivir 2 mg/kg/dose or placebo twice daily for 5 days. ⁶

TAMIFLU is indicated for the treatment of influenza in patients 1 year and older who have been symptomatic for no more than 2 days.

Learn about TAMIFLU side effects and safety.

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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.

1-Minute Video Series

TAMIFLU for Treatment of Influenza

TAMIFLU for Treatment of Influenza