Important Safety Information
Indications
TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses (virus) types
A and B in patients 1 year and older who have had flu symptoms for no more than 2 days.
TAMIFLU is also indicated for the prevention of influenza in patients 1 year and older.
TAMIFLU is not a substitute for annual early vaccination as recommended by the Centers for
Disease Control and Prevention.
Safety Information
TAMIFLU has not been shown to be effective against any illness other than that caused by
influenza types A and B. Efficacy of treatment in patients with chronic cardiac and/or respiratory
disease has not been established. No difference in the incidence of complications was seen 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 courses of TAMIFLU for treatment or
prevention have not been studied. In postmarketing experience, rare cases of
anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson
syndrome and erythema multiforme, have been reported.
There have been postmarketing reports (mostly from Japan) of self-injury and
delirium with the use of TAMIFLU in patients with influenza. The reports were primarily
among children. The relative contribution of the drug to these events is not known.
Patients with influenza should be closely monitored for signs of abnormal behavior
throughout the treatment period.
In treatment studies in adult patients, the most frequently reported adverse
events (incidence ≥ 1%) were nausea and vomiting. Other events reported numerically
more frequently in patients taking TAMIFLU compared with placebo were bronchitis,
insomnia and vertigo. In treatment studies in patients 1 to 12 years old, the most
frequently reported adverse event (incidence ≥ 1%) was vomiting (15%). Other events
reported more frequently in patients taking TAMIFLU compared with placebo included
abdominal pain (5% vs 4%), nosebleed (3% vs 3%), ear disorder (2% vs 1%) and pinkeye (1% vs < 1%).
In prophylaxis studies in adult patients, adverse events were similar to those seen in
the treatment studies. Events reported more frequently in patients taking TAMIFLU compared
with placebo (incidence ≥ 1%) were nausea (7% vs 3%), vomiting (2% vs 1%), diarrhea (3% vs 2%),
abdominal pain (2% vs 1%), dizziness (1% vs 1%), headache (18% vs 18%) and insomnia (1% vs 1%).
In a household prevention trial that included patients 1 to 12 years old, adverse events were
similar to those observed in pediatric treatment studies, with GI events being the most common.
The concurrent use of TAMIFLU and live attenuated influenza vaccine (LAIV) intranasal
has not been evaluated. However, due to the possibility for interference between these
products, LAIV should not be given within 2 weeks before or 48 hours after taking TAMIFLU,
unless it is deemed appropriate by your doctor. Trivalent inactivated influenza vaccine
can be administered at any time relative to use of TAMIFLU.