Tamiflu Is Indicated for Treatment of Infants 2 Weeks and Older
Indications and Limitations of Use
Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age 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.
- Safety and efficacy of Tamiflu for treatment of influenza in pediatric patients less than 2 weeks of age have not been established.
- Safety and efficacy of Tamiflu for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age.
The following points should be considered before initiating treatment with Tamiflu1:
Patients 2 weeks of age and older may benefit from treatment with Tamiflu for influenza.1
Results from 2 open-label pharmacokinetic and safety studies of 136 children 2 weeks to less than 1 year of age infected with influenza tested how well Tamiflu was tolerated in this population. By extrapolation, a 3 mg/kg twice-daily dose for 5 days is expected to provide efficacy similar to that seen in older pediatric patients.1
The safety profile observed in infants less than 1 year of age was consistent with the established safety profile of pediatric subjects aged 1 year and above, with vomiting, diarrhea, and diaper rash being the most frequently reported adverse reactions.
Treatment Dosing of Tamiflu for
Influenza in Pediatric Patients Aged 2 Weeks to Less Than 1 Year
|Weight (kg)||Treatment dosing for 5 days||Prophylaxis dosing for 10 days||Volume of Oral Suspension (6 mg/mL) for each dose**||Number of bottles of Oral Suspension to dispense||Number of capsules and strength to dispense§|
|Any weight||3 mg/kg twice daily||Not applicable*||0.5 mL/kg†||1 bottle||Not applicable|
Tamiflu is not approved for prophylaxis of patients less than 1 year of age.
An oral dosing dispensing device that measures the appropriate volume in mL should be utilized with the oral suspension.
For patients less than 1 year of age, provide an appropriate dosing device that can accurately measure and administer small volumes.
Oral Suspension is the preferred formulation for patients who cannot swallow capsules.
Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age 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
- Efficacy of Tamiflu in patients who begin treatment after 48 hours of symptoms has not been established
- Tamiflu is not a substitute for early and annual influenza vaccination
- There is no evidence for efficacy of Tamiflu in any illness caused by agents other than influenza viruses types A and B
- Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu
Serious Skin/Hypersensitivity Reactions
- Tamiflu is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of Tamiflu
- In postmarketing experience, cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected
- 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
- Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient
- Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications
Limitations of Populations Studied
- Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization
- Efficacy of Tamiflu for treatment or prophylaxis of influenza has not been established in immunocompromised patients
Concurrent Use with Live Attenuated Influenza Vaccine
- The concurrent use of Tamiflu with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated
Most Common Adverse Reactions
- Adverse events that occurred more frequently in patients treated with Tamiflu than in patients taking placebo (frequency ≥ 2%) across clinical trials were nausea, vomiting, abdominal pain, ear disorder, and diarrhea
- The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of subjects aged 1 year and above, with vomiting, diarrhea and diaper rash being the most frequently reported adverse reactions
For additional important safety information, please see Tamiflu full prescribing information at www.tamiflu.com.
You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
- Tamiflu® (oseltamivir phosphate) Prescribing Information. South San Francisco, CA: Genentech USA, Inc.; January, 2013