Dosing and Storage

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.

Dosing for Treatment and Prophylaxis of Pediatric and Adult Patients

Tamiflu may be taken with or without food. However, when it is taken with food, tolerability may be enhanced in some patients. Use the dosing charts below to find the right dosage of Tamiflu for your pediatric and adult patients within 2 days of symptom onset.

Dosing chart for pediatric patients

Tamiflu Dosing Information for Influenza in Pediatric Patients chart

The recommended duration for post-exposure prophylaxis is 10 days and the recommended duration for community outbreak (seasonal/pre-exposure) prophylaxis is up to 6 weeks (or up to 12 weeks in immunocompromised patients). The amount supplied (e.g., number of bottles or capsules) for seasonal prophylaxis may be greater than for post-exposure prophylaxis.

Use an oral dosing dispensing device that measures the appropriate volume in mL with the oral suspension.

TAMIFLU for oral suspension is the preferred formulation for patients who cannot swallow capsules.

For patients less than 1 year of age, provide an appropriate dosing device that can accurately measure and administer small volumes.

Dosing for adult patients

Flu treatment for adults and teens aged 13 years and older

  • Take 75 mg, twice daily, for 5 days.

Flu prevention for adults and teens aged 13 years and older

  • Take 1 dose, once daily, for 10 days or as long as prescribed.

One dose is 75 mg/12.5 mL for adults and teens

Capsules or oral suspension can be used for 30 mg dosing.

The recommended duration for post-exposure prophylaxis is at least 10 days and the recommended duration for community outbreak (seasonal/pre-exposure) prophylaxis is up to 6 weeks (or up to 12 weeks in immunocompromised patients).

Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients.

Please see the Tamiflu full Prescribing Information for complete safety information.

What if the local pharmacy does not have any Tamiflu for Oral Suspension in stock?

Tamiflu provides the flexibility for healthcare professionals to treat and prevent influenza with alternatives to oral suspension:

  • Tamiflu 30-mg or 45-mg capsules, depending on the weight of the child.
  • For patients with difficulty swallowing capsules, contents can be mixed into sweetened liquids, such as chocolate syrup, by a caregiver.

In emergency situations, if commercially manufactured Tamiflu for Oral Suspension is not readily available from wholesalers or Genentech, a liquid suspension can be prepared in an emergency by a pharmacist using Tamiflu 75-mg capsules. Instructions for dosing and compounding may be found in the Tamiflu Prescribing Information.

Taking Tamiflu with other medications1

Oseltamivir is extensively converted to oseltamivir carboxylate by esterases, located predominantly in the liver.

Drug interactions involving competition for esterases have not been extensively reported in literature. Low protein binding of oseltamivir and oseltamivir carboxylate suggests that the probability of drug displacement interactions is low.

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 TAMIFLU administration, unless medically indicated. Inactivated influenza vaccine can be administered at any time relative to use of TAMIFLU.

Oseltamivir carboxylate is not further metabolized. Neither oseltamivir nor oseltamivir carboxylate is a substrate for, or inhibitor of, cytochrome P450 isoforms.

No clinically relevant pharmacokinetic interactions have been observed when coadministering oseltamivir with amoxicillin, acetaminophen, aspirin, cimetidine, antacids (magnesium and aluminum hydroxides and calcium carbonates), rimantadine, amantadine, or warfarin.

Storing Tamiflu for Oral Suspension1

Store dry powder at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Storing Constituted Tamiflu for Oral Suspension1

Store constituted suspension under refrigeration for up to 17 days at 2° to 8°C (36° to 46°F). Do not freeze. Alternatively, store constituted suspension for up to 10 days at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Did You Know?

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

Learn more >

References

  1. Tamiflu® (oseltamivir phosphate) Prescribing Information. South San Francisco, CA: Genentech USA, Inc.; June 2016.
  2. 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.

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