TAMIFLU Indications and Safety Information

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.

 

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. Other events reported more frequently in patients taking TAMIFLU compared with placebo included abdominal pain, epistaxis, ear disorder and conjunctivitis. 

 

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, vomiting, diarrhea, abdominal pain, dizziness, headache and insomnia. In a household prophylaxis trial that included patients 1 to 12 years old, adverse events were consistent with those observed in pediatric treatment studies, with GI events being the most frequently observed.

 

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. Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

 

In post-marketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.

 

Vaccination is considered the first line of defense against influenza.