EMERGENCY USE AUTHORIZATION of TAMIFLU®: dosing syringe or other device may be used to deliver the following volumes:

FACT SHEET FOR HEALTH CARE PROVIDERS1 2.5 mL (1/2 tsp) for children ≤ 15 kg, 3.8 mL (3/4 tsp) for > 15 kg to 23 kg,
5 mL (1 tsp) for > 23 kg to 40 kg, and 6.2 mL (1 ¼ tsp) for > 40 kg.
You have been asked as a health care provider to give TAMIFLU® (oseltamivir Pediatric Patients less than 1 year old*
phosphate) to people who have been exposed to novel Influenza A (H1N1) (Swine
Influenza A). TAMIFLU® is approved by the U.S. Food and Drug Administration Body Weight (kg) Dose by Age Recommended Treatment Dose for 5
(FDA) to treat and prevent influenza. Certain aspects of the emergency use are not Days (Dose in volume is based on the
concentration (12 mg/mL) of commercially-
part of the approved drug applications, such as use in pediatric patients less than 1
manufactured TAMIFLU® Oral Suspension)
year old, use in patients who are symptomatic for more than 2 days, and use in Dosing for infants < 3 months 12 mg (1 mL) twice daily
patients who have complicated illness requiring hospitalization. For more younger than 1 year
information, refer to http://www.cdc.gov/h1n1flu or www.fda.gov. 3-5 months 20 mg (1.6 mL) twice daily
not based on weight
6-11 months 25 mg (2 mL) twice daily
Recommended Treatment Dosage
*For more information regarding the basis for dose recommendations, see FDA’s “Tamiflu Technical Review
Adults and Adolescents 13 years and older: 75 mg twice daily for 5 days. Document for H1N1 Influenza A” on www.cdc.gov/h1n1flu or www.fda.gov.
Treatment should begin as soon as possible after symptom onset.
For infants less than 1 year old, a different measuring device (such as a 5-mL
Pediatric Patients 1 to 12 years old: Dosage is shown in the following table. For oral syringe) must be used to correctly measure the dose.
pediatric patients who cannot swallow capsules, TAMIFLU® for Oral Suspension
is the preferred formulation. If the oral suspension product is not available, Recommended Prophylaxis Dosage
TAMIFLU® Capsules may be opened and mixed with sweetened liquids such as Adults and Adolescents 13 years and older: 75 mg once daily for at least 10
regular or sugar-free chocolate syrup. days following close contact with an infected person. Therapy should begin as
Body Body Age Dose for 5 # Bottles of Oral # of Capsules soon as possible after exposure. The recommended dose for prophylaxis during
Weight Weight (years) Days Suspension Needed a community outbreak of influenza is 75 mg once daily. Safety and efficacy
(kg) (lbs) Needed for the 5 for the have been demonstrated for up to 6 weeks. The duration of protection lasts for
Day Regimen 5 Day as long as dosing is continued.
Regimen
≤ 15 ≤ 33 1-2 30 mg twice 1 10 capsules Pediatric Patients 1 to 12 years old: Dosage following close contact with an
daily (30 mg) infected individual is shown in the following table. For pediatric patients who
> 15-23 > 33-51 3-5 45 mg twice 2 10 capsules cannot swallow capsules, TAMIFLU® for Oral Suspension is the preferred
daily (45 mg) formulation. If the oral suspension product is not available, TAMIFLU®
> 23-40 > 51-88 6-9 60 mg twice 2 20 capsules Capsules may be opened and mixed with sweetened liquids such as regular or
daily (30 mg)
sugar-free chocolate syrup.
> 40 > 88 10-12 75 mg twice 3 10 capsules
daily (75 mg)

An oral dosing dispenser with 30 mg, 45 mg, and 60 mg graduations is provided

with TAMIFLU® for Oral Suspension; the 75 mg dose can be measured using a
combination of 30 mg and 45 mg. It is recommended that patients use this
dispenser. In the event that the dispenser provided is lost or damaged, another

1
In the event of an emergency, it is possible that public health officials or other volunteers might distribute
TAMIFLU® products to recipients as authorized. In this fact sheet, the term "health care provider(s)" includes
these individuals and is used for brevity here.

TAMIFLU® EUA, Fact Sheet for Health Care Providers: July 14, 2009
 Body Body Dose Dose for # Bottles of Oral Number of Special Dosage Instructions
Weight Weight by Age 10 Days Suspension Capsules No dose adjustment is recommended for patients with mild or moderate hepatic
(kg) (lbs) (years) Needed for the Needed for
impairment (Child-Pugh score ≤ 9). No dose adjustment is required for geriatric
10 Day Regimen the 10 Day
Regimen patients.
≤ 15 ≤ 33 1-2 30 mg 1 10 capsules Renal Impairment, Recommended Treatment Dosage: Dose adjustment is
once daily (30 mg) recommended for patients with creatinine clearance between 10 and 30 mL/min.
> 15-23 > 33-51 3-5 45 mg 2 10 capsules Treatment dose should be reduced to 75 mg once daily for 5 days. No
once daily (45 mg)
recommended dosing regimens are available for patients undergoing routine
> 23-40 > 51-88 6-9 60 mg 2 20 capsules
once daily (30 mg) hemodialysis and continuous peritoneal dialysis treatment with end-stage renal
> 40 > 88 10-12 75 mg 3 10 capsules disease.
once daily (75 mg) Renal Impairment, Recommended Prophylaxis Dosage: Dose adjustment is
recommended for patients with creatinine clearance between 10 and 30 mL/min
An oral dosing dispenser with 30 mg, 45 mg, and 60 mg graduations is provided receiving TAMIFLU®. In these patients it is recommended that the dose be
with TAMIFLU® for Oral Suspension; the 75 mg dose can be measured using a reduced to 75 mg of TAMIFLU® every other day or 30 mg TAMIFLU® every
combination of 30 mg and 45 mg. It is recommended that patients use this day. No recommended dosing regimens are available for patients undergoing
dispenser. In the event that the dispenser provided is lost or damaged, another routine hemodialysis and continuous peritoneal dialysis treatment with
dosing syringe or other device may be used to deliver the following volumes: end-stage renal disease.
2.5 mL (1/2 tsp) for children ≤ 15 kg, 3.8 mL (3/4 tsp) for > 15 kg to 23 kg, 5
Preparation of TAMIFLU® for Oral Suspension
mL (1 tsp) for > 23 kg to 40 kg, and 6.2 mL (1 ¼ tsp) for > 40 kg.
TAMIFLU® for Oral Suspension may be constituted by a pharmacist or health
Prophylaxis in pediatric patients following close contact with an infected care provider.
individual is recommended for 10 days. Prophylaxis in patients 1 to 12 years of 1. Tap the closed bottle several times to loosen the powder.
age has not been evaluated for longer than 10 days duration. Therapy should 2. Measure 23 mL of water in a graduated cylinder.
begin soon as possible. 3. Add the total amount of water for constitution to the bottle and shake
Pediatric Patients less than 1 year old* the closed bottle well for 15 seconds.
4. Remove the child-resistant cap and push bottle adapter into the neck of
Body Weight (kg) Dose by Age Recommended Prophylaxis Dose for
the bottle.
10 Days (Dose in volume is based on the
concentration (12 mg/mL) of commercially- 5. Close bottle with child-resistant cap tightly. This will assure the proper
manufactured TAMIFLU® for Oral seating of the bottle adapter in the bottle and child-resistant status of the
Suspension) cap.
Dosing for infants < 3 months Not recommended unless situation NOTE: SHAKE THE TAMIFLU® FOR ORAL SUSPENSION WELL
younger than 1 year judged critical BEFORE EACH USE.
not based on weight 3-5 months 20 mg (1.6 mL) once daily
Store constituted suspension under refrigeration at 2-8°C (36-46°F). Do not
6-11 months 25 mg (2 mL) once daily
freeze. The constituted TAMIFLU® for Oral Suspension (12 mg/mL) should be
*For more information regarding the basis for dose recommendations, see FDA’s “Tamiflu Technical Review used within 10 days of preparation; the pharmacist, health care official, patient,
Document for H1N1 Influenza A” on www.cdc.gov/h1n1flu or http://www.fda.gov.
or patient’s parent or guardian should write the date of expiration of the
For infants less than 1 year old, a different measuring device (such as a 5-mL constituted suspension on the label. The Fact Sheet for Patients and Parents and
oral syringe) must be used to correctly measure the dose. oral dispenser should be dispensed to the patient.

TAMIFLU® EUA, Fact Sheet for Health Care Providers: July 14, 2009
Expired TAMIFLU® for Oral Suspension Reporting And Monitoring Adverse Events
If you have been asked to distribute/dispense TAMIFLU® for Oral Suspension Health care providers and recipients that experience adverse events or
that is past its original labeled expiration date, please be aware that the medication errors are encouraged to report to MedWatch at
expiration date may have been extended as part of the federal government’s www.fda.gov/medwatch, by submitting a MedWatch Form 3500 (available at
Shelf Life Extension Program (SLEP). Under SLEP, FDA conducts scientific http://www.fda.gov/medwatch/safety/FDA-3500_fillable.pdf) or by calling
testing to see if specific lots of TAMIFLU® can be used beyond the expiration 1-800-FDA-1088.
dates originally printed on the label by the manufacturer. If the product passes
testing, FDA determines that the shelf life of the product can be extended
beyond the expiration dates originally printed on the label. For any
TAMIFLU® for Oral Suspension that is past its original labeled expiration
date, you may look up the lot number at the following website to determine
if the expiry date for this lot has been extended and for how long:
www.cdc.gov/h1n1flu/eua. For TAMIFLU® for Oral Suspension whose
expiration date has been extended, you may inform recipients of the new
expiration date.
What are the Possible Side Effects of TAMIFLU®?
The side effects reported most often in those people who took this drug were
gastrointestinal (i.e., nausea and vomiting). Nausea and vomiting may be less
severe if TAMIFLU® is taken with food.
Rare cases of anaphylaxis and serious skin reactions including toxic epidermal
necrolysis, Stevens-Johnson Syndrome, and erythema multiforme have been
reported in post marketing experience with TAMIFLU®. TAMIFLU® should be
stopped and appropriate treatment instituted if an allergic-like reaction occurs or
is suspected.
There have been postmarketing reports of delirium and abnormal behavior
leading to injury, and in some cases resulting in fatal outcomes, in patients with
influenza who were receiving TAMIFLU®. These events may occur in the
setting of encephalitis or encephalopathy but can occur without obvious severe
disease. 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.
Refer to the Package Insert for more safety information.
Make available to recipients the information in the Fact Sheet for Patients
and Parents

TAMIFLU® EUA, Fact Sheet for Health Care Providers: July 14, 2009