Pediatric Treatment

Treating Influenza in Children 2 Weeks to Under 1 Year of Age

Indications and Limitations of Use

TAMIFLU is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. TAMIFLU is indicated for the prophylaxis of influenza A and B 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:

  • TAMIFLU is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
  • Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.
  • TAMIFLU is not recommended for patients with end-stage renal disease not undergoing dialysis.

Patients 2 weeks of age and older may benefit from treatment with Tamiflu for influenza.1

The safety and efficacy of TAMIFLU for the treatment of influenza in pediatric patients 2 weeks to less than 1 year of age is supported by adequate and well-controlled trials in adults and older pediatric patients and two open-label trials of TAMIFLU.

The two open-label trials evaluated the safety and pharmacokinetics of oseltamivir and oseltamivir carboxylate in 136 influenza-infected pediatric subjects 2 weeks to less than 1 year of age (including premature infants at least 36 weeks post conceptional age). Subjects received TAMIFLU at doses ranging from 2 to 3.5 mg per kg twice daily for 5 days depending on subject age. These clinical trials were not designed to evaluate clinical efficacy or virologic response.

In these two trials, the oseltamivir plasma concentrations in these subjects were similar to or higher than the oseltamivir plasma concentrations observed in older pediatric subjects and adults.

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.

Treating Influenza in Children Aged 1-12 Years

Indications and Limitations of Use

TAMIFLU is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. TAMIFLU is indicated for the prophylaxis of influenza A and B in patients 1 year and older.

The following points should be considered before initiating treatment with Tamiflu1:

  • TAMIFLU is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
  • Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.
  • TAMIFLU is not recommended for patients with end-stage renal disease not undergoing dialysis.

How to treat influenza in children aged 1-12 years

Tamiflu significantly reduced flu duration by 36 hours (26%) compared with placebo in children aged 1 through 12 years.1,2

In children 1-12 years of age: 26% (36 hours) reduction in duration of illness1,2

Tamiflu flu treatment for children, reduction in duration of illness chart

About the study

  • Tamiflu significantly reduced flu duration by 26% (36 hours) vs placebo (P<0.0001).1,2
  • Tamiflu reduced median duration of fever by 25 hours.1,2

Results are from a double-blind, placebo-controlled treatment trial conducted in 698 pediatric subjects aged 1 to 12 years. All included patients had fever (≥100°F) plus 1 respiratory symptom (cough or coryza), and 452 were influenza-infected. Study participants received Tamiflu 2 mg/kg twice daily or placebo within 2 days of symptom onset. The primary efficacy end point was time to freedom from illness, a composite end point that required 4 individual conditions be met: alleviation of cough, alleviation of coryza, resolution of fever, and parental opinion of a return to normal health and activity.

Did You Know?

In a clinical study, Tamiflu prophylaxis reduced postexposure flu transmission in children aged 1-12 years by 82%.2,3

Learn more >


References

  1. Tamiflu® (oseltamivir phosphate) Prescribing Information. South San Francisco, CA: Genentech USA, Inc.; June 2016.
  2. Whitley RJ, Hayden FG, Reisinger KS, et al. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J. 2001;20:127-133.
  3. Hayden FG, Belshe R, Villanueva C, et al. Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis. J Infect Dis. 2004;189:440-449.

Indications

TAMIFLU is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. TAMIFLU is indicated for the prophylaxis of influenza A and B in patients 1 year and older.

  • TAMIFLU is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
  • Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.
  • TAMIFLU is not recommended for patients with end-stage renal disease not undergoing dialysis.

Important Safety Information

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, or erythema multiforme to Tamiflu or any component of the product.
  • 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.

Neuropsychiatric Events

  • 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. Closely monitor Tamiflu-treated patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient.

Risk of Bacterial Infections

  • There is no evidence for efficacy of Tamiflu in any illness caused by pathogens other than influenza viruses. 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.

Fructose Intolerance in Patients with Hereditary Fructose Intolerance

  • Fructose can be harmful to patients with hereditary fructose intolerance. One dose of 75 mg Tamiflu for oral suspension delivers 2 grams of sorbitol. This is above the daily maximum limit of sorbitol for patients with hereditary fructose intolerance, and may cause dyspepsia and diarrhea.

Use in Specific Populations

  • Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease was evaluated in one randomized, placebo-controlled clinical trial. Efficacy in this population was not established, but no new safety signals were identified.
  • No clinical trial data are 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
  • 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

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 Tamiflu to inhibit replication of live vaccine virus and possibly reduce the efficacy of LAIV, avoid administration of LAIV within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated.

Most Common Adverse Reactions

  • Adverse reactions that occurred in ≥ 1% of Tamiflu-treated adults and adolescents (13 years of age and older) and ≥ 1% greater in Tamiflu-treated subjects when compared to placebo-treated subjects were:
    • Pooled treatment trials - nausea (10%, 6%), vomiting (8%, 3%), headache (2%, 1%)
    • Pooled prophylaxis trials- nausea (8%, 4%), vomiting (2%, 1%), headache (17%, 16%) pain (4%, 3%)
  • Pediatric subjects 1 to 12 years of age: In the treatment trials, vomiting was the only adverse reaction reported at a frequency of ≥ 1% in subjects receiving Tamiflu (16%) compared to placebo (8%). In the prophylaxis trials, vomiting was the most frequent adverse reaction (8% Tamiflu versus 2% in the no prophylaxis group).
  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was similar across the age range studied, with vomiting (9%), diarrhea (7%) and diaper rash (7%) 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.

Indications and Important Safety Information

Indications

TAMIFLU is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. TAMIFLU is indicated for the prophylaxis of influenza A and B in patients 1 year and older.

  • TAMIFLU is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
  • Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.
  • TAMIFLU is not recommended for patients with end-stage renal disease not undergoing dialysis.

Important Safety Information

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, or erythema multiforme to Tamiflu or any component of the product.
  • 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.

Neuropsychiatric Events

  • 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. Closely monitor Tamiflu-treated patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient.

Risk of Bacterial Infections

  • There is no evidence for efficacy of Tamiflu in any illness caused by pathogens other than influenza viruses. 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.

Fructose Intolerance in Patients with Hereditary Fructose Intolerance

  • Fructose can be harmful to patients with hereditary fructose intolerance. One dose of 75 mg Tamiflu for oral suspension delivers 2 grams of sorbitol. This is above the daily maximum limit of sorbitol for patients with hereditary fructose intolerance, and may cause dyspepsia and diarrhea.

Use in Specific Populations

  • Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease was evaluated in one randomized, placebo-controlled clinical trial. Efficacy in this population was not established, but no new safety signals were identified.
  • No clinical trial data are 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
  • 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

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 Tamiflu to inhibit replication of live vaccine virus and possibly reduce the efficacy of LAIV, avoid administration of LAIV within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated.

Most Common Adverse Reactions

  • Adverse reactions that occurred in ≥ 1% of Tamiflu-treated adults and adolescents (13 years of age and older) and ≥ 1% greater in Tamiflu-treated subjects when compared to placebo-treated subjects were:
    • Pooled treatment trials - nausea (10%, 6%), vomiting (8%, 3%), headache (2%, 1%)
    • Pooled prophylaxis trials- nausea (8%, 4%), vomiting (2%, 1%), headache (17%, 16%) pain (4%, 3%)
  • Pediatric subjects 1 to 12 years of age: In the treatment trials, vomiting was the only adverse reaction reported at a frequency of ≥ 1% in subjects receiving Tamiflu (16%) compared to placebo (8%). In the prophylaxis trials, vomiting was the most frequent adverse reaction (8% Tamiflu versus 2% in the no prophylaxis group).
  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was similar across the age range studied, with vomiting (9%), diarrhea (7%) and diaper rash (7%) 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.

You are Now Leaving Tamiflu.com

The link you have selected will take you away from this site to one that is owned by a third-party and is not owned by Genentech, Inc. Unless otherwise noted on the third-party site, Genentech, Inc. does not own, control or influence content on this third-party site. For such content, Genentech, Inc. makes no representation as to the accuracy of this information and does not recommend or endorse it. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

Tell a Colleague