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U.S. Department of Health and Human Services

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Emergency Use of Tamiflu in Infants Less than 1 Year of Age

 

The information previously contained on this page was authorized under the 2009 H1N1 Influenza Emergency Use Authorizations (EUAs). As of June 23, 2010, the EUAs have been terminated and this information is no longer current. Please go to "Tamiflu and Relenza Emergency Use Authorization Disposition Letters and Question and Answer Attachments " for the most current information.

 

On October 30th, 2009, FDA issued an amendment to the Emergency Use Authorization for Tamiflu that included dosing recommendations based on weight for infants less than 1 year of age. This document was originally issued by FDA on 09-25-2009 and included age-based doses for treatment and prophylaxis for infants less than 1 year of age.

Tamiflu for Oral Suspension is approved for use in treatment and prophylaxis of influenza in pediatric patients 1 year of age and older. In certain cases, FDA has authorized emergency use of Tamiflu in infants less than 1 year of age.

Health care providers should be aware that there are limited data on safety and dosing when considering Tamiflu use in seriously ill, young infants with confirmed 2009 H1N1 influenza, or in one that has been exposed to a confirmed 2009 H1N1 influenza case. Infants should be carefully monitored for adverse events when Tamiflu is used.

Tamiflu should not be routinely used for prophylaxis in infants less than 3 months of age due to extremely limited pharmacokinetic data to guide dosing in this age group. Prophylaxis with Tamiflu in infants less than 3 months of age should be reserved for cases in which the exposure is significant and the risk of severe illness is considered high.

The following tables provide treatment (Table 1) and prophylaxis (Table 2) dosing recommendations for the emergency use of Tamiflu in Infants less than 1 year of age:

Table 1. Recommended Treatment Dose for Infants Less than 1 year of age Using Tamiflu Oral Suspension


Age
Recommended Treatment Dose for 5 Days (weight-based dosing)†
Less than 12 months3 mg/kg/dose twice a day

†Weight-based dosing is preferred, however, if weight is not known, dosing by age for treatment of influenza in full-term infants younger than 1 year of age may be necessary (birth-2 months = 12 mg (1 mL) twice daily; 3-5 months = 20 mg (1.6 mL) twice daily, 6-11 months = 25 mg (2 mL) twice daily)

Table 2. Recommended Prophylaxis Dose for Infants Less than 1 year of age Using Tamiflu Oral Suspension


Age
Recommended Prophylaxis Dose for 10 Days (weight-based dosing)††
3 months to less than 12 months3 mg/kg/dose once daily

Younger than 3 months
Not recommended unless situation judged critical due to limited data on use in this age group

††Weight-based dosing is preferred, however, if weight is not known, dosing by age for prophylaxis of influenza in full-term infants younger than 1 year of age may be necessary (3-5 months = 20 mg once daily (1.6 mL), 6-11 months = 25 mg (2 mL) once daily).

Current weight-based dosing recommendations are not intended for premature infants.  Premature infants may have slower clearance of Tamiflu due to immature renal function, and doses recommended for full term infants may lead to very high drug concentrations in this age group.  Very limited data from a cohort of premature infants receiving an average dose of 1.7 mg/kg twice daily demonstrated drug concentrations higher than those observed with the recommended treatment dose in term infants (3 mg/kg twice daily).  Observed drug concentrations were highly variable among premature infants.  These data are insufficient to recommend a specific dose of Tamiflu for premature infants.

When dispensing Tamiflu oral suspension for infants younger than 1 year of age, the oral dosing dispenser included in the product package should always be removed and replaced with an appropriate measuring device.  The pharmacist or other health care provider should provide a 3 ml or 5 ml oral syringe to correctly measure the dose and counsel the caregiver on how to administer the prescribed dose.