Home | Print This Page | Site Map
Search
blue bar
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 is the efficacy and safety profile of TAMIFLU?

Proven efficacy in clinical trials*

Treatment34

In clinical trials for seasonal flu, adult patients who took TAMIFLU started to feel better sooner (30%, or 1.3 days faster) compared with patients who did not take TAMIFLU. Patients took TAMIFLU 75 mg twice daily for 5 days. Similar results were seen in children.
 
For more information, visit http://www.tamiflu.com/hcp/treatment/treat_index.asp.

Prevention

The results of a clinical study showed that TAMIFLU was effective for postexposure prophylaxis in adolescents and adults when taken once daily for 7 days.40 In this study, 24 of 200 contacts in the placebo group developed clinical influenza compared with 2 of 205 patients taking TAMIFLU. The protective efficacy of TAMIFLU in this group was 92%.40 Similar results were seen in children.
 
For more information, visit http://www.tamiflu.com/hcp/prophylaxis/prophy_index.asp.


Tamiflu 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 or associated with avian flu) cannot be predicted.

Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza


Safety and tolerability


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.



 
Learn about TAMIFLU's resistance profile.

 
FOOTNOTE
34. Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. JAMA. 2000;283:1016-1024.
40. Welliver R, Monto AS, Carewicz O, et al. Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA. 2001;285:748-754
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.
Home |  
Antiviral Supply and Ordering  |  State & Local Government Resources  |  
Important Safety Information  |  Contact Us  |  Site Map
spacer.gif
Complete Product Information  |   Legal Statement   |  Privacy Statement   |  Unsubscribe

 

Roche THIS SITE INTENDED FOR U.S. AUDIENCES ONLY#9959900
Copyright © 2006-20102006-2010 Roche Laboratories Inc. All rights reserved. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Statement.