Important Prescribing Information
Page 1
Subject: Announcing a new strength of TAMIFLU® (oseltamivir phosphate) for Oral Suspension –
changing the concentration from 12 mg/mL to 6 mg/mL and the dispenser from mgs to mLs
Dear Healthcare Provider,
Genentech is pleased to introduce a new strength of TAMIFLU for Oral Suspension 6 mg/mL. We have changed the
concentration from 12 mg/mL to 6 mg/mL and the dispenser from mgs to mLs to help reduce the potential for prescribing
and dosing confusion. (The 12 mg/mL concentration is no longer being manufactured.)
Tamiflu is indicated in patients 1 year and older for the treatment of uncomplicated influenza in those who have been
symptomatic for no more than 2 days and for the prophylaxis of influenza.
Important prescribing information (revised March 2011) 1
Prescribe TAMIFLU for appropriate patients as follows:
Formulation and concentration (or strength):
Oral Suspension (6 mg/mL) or capsules (30 mg, 45 mg, or 75 mg)
Dose:
mL (preferred for Oral Suspension) or mg (preferred for capsules), based on patient’s weight.
Refer to the Dosing Table below for more information.
Frequency and Duration:
Treatment: twice daily for five days
Prophylaxis: once daily, typically
s &OR TEN DAYS FOR POST
EXPOSURE PROPHYLAXIS OR
s &OR UP TO SIX WEEKS DURING A COMMUNITY OUTBREAK
Updated Dosing Table (Revised March 2011) 1
Treatment and Prophylaxis Dosing of Oral TAMIFLU for Influenza
For Patients 1 Year of Age and Older Based on Body Weight†
Weight (kg) Weight (lbs) Treatment Dosing for Prophylaxis Dosing Volume of Oral Number of Number of Capsules
5 days for 10 days‡ Suspension Bottles of Oral and Strength
(6 mg/mL) Suspension to to Dispense
for Each Dose* Dispense
15 kg or less 33 lbs or less 30 mg twice daily 30 mg once daily 5 mL 1 bottle 10 Capsules, 30 mg
16 kg thru 23 kg 34 lbs thru 51 lbs 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 Capsules, 45 mg
24 kg thru 40 kg 52 lbs thru 88 lbs 60 mg twice daily 60 mg once daily 10 mL 2 bottles 20 Capsules, 30 mg
41 kg or more 89 lbs or more 75 mg twice daily 75 mg once daily 12.5 mL **
3 bottles 10 Capsules, 75 mg
† Treatment should begin within 2 days of onset of symptoms and prophylaxis should begin within 2 days of exposure to an infected individual. Please
see the Prescribing Information for dosing in patients with renal impairment.
‡ Prophylaxis for adults following close contact with an infected individual
FOR AT LEAST DAYS $URATION OF PROPHYLAXIS IN BOTH ADULTS AND PEDIATRIC PATIENTS DURING A COMMUNITY OUTBREAK IS UP TO WEEKS IN IMMUNOCOMPETENT
patients.
* A 10 mL oral dosing dispenser is provided with the oral suspension. In the event that the dispenser provided is lost or damaged, another dosing
dispenser may be used to deliver the volumes.
** Delivery of this TAMIFLU for Oral Suspension dose requires administering 10 mL followed by another 2.5 mL.
1
Please see Prescribing Information (enclosed or available at www.Tamiflu.com/HCP)
Important Prescribing Information
Page 2
TAMIFLU in Multiple Formulations1
TAMIFLU provides healthcare providers with multiple options to treat influenza patients:
For pediatric and adult patients who can swallow capsules, the following options are available:
TAMIFLU 30 mg, 45 mg or 75 mg capsules
For pediatric and adult patients who cannot swallow capsules, the following options are available:
TAMIFLU for Oral Suspension 6 mg/mL
TAMIFLU 30 mg, 45 mg or 75 mg capsules, opened and mixed with a liquid by caregiver1
If TAMIFLU for Oral Suspension is unavailable, TAMIFLU 75 mg capsules can be compounded into a 6 mg/mL
oral suspension by a pharmacist.1
Please see the full Indication and Limitations of Use and Important Safety Information for Tamiflu attached
at the end of this letter.
Please see the enclosed full prescribing information for Tamiflu. Genentech encourages you to become familiar with these
prescribing instructions. If you have any questions or require additional information concerning TAMIFLU, please refer to
these resources for further details:
TAMIFLU.com Website:
www.Tamiflu.com/HCP (general information for healthcare providers)
www.Tamiflu.com/OS (detailed information on the Oral Suspension)
'ENENTECH -EDICAL )NFORMATION#OMMUNICATIONS $EPARTMENT
Genentech will continue to monitor the safety of TAMIFLU through established reporting mechanisms and notify regulatory
authorities of any serious adverse events for evaluation. We will continue to provide you with the most current product
information for TAMIFLU moving forward. You can assist us in monitoring the safety of TAMIFLU by reporting adverse
REACTIONS TO US AT
BY &!8 AT
OR TO &$! AT WWWFDAGOVMEDWATCH OR BY MAIL TO -ED7ATCH
FDA Federal Safety Information and Adverse Event Reporting Program, Food and Drug Administration, 5600 Fishers Lane,
2OCKVILLE -$
Sincerely,
Hal Barron, MD
Executive Vice President, Global Development and Chief Medical Officer
Genentech, A Member of the Roche Group
1
Please see Prescribing Information (enclosed or available at www.Tamiflu.com/HCP)
Important Prescribing Information
Page 3
Indications and Limitations of Use
TAMIFLU is indicated in patients 1 year and older for the treatment of uncomplicated influenza caused by viruses types A
and B who have been symptomatic for no more than 2 days and for the prophylaxis of influenza.
%FlCACY OF 4!-)&,5 IN PATIENTS WHO BEGIN TREATMENT AFTER HOURS OF SYMPTOMS HAS NOT BEEN ESTABLISHED
TAMIFLU is not a substitute for early and annual vaccination as recommended by the Centers for Disease Control’s Advisory
Committee on Immunization Practices (ACIP).
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. Other factors
(for example, changes in viral virulence) might also diminish clinical benefits of antiviral drugs. Prescribers should consider
available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu.
Important Safety Information
4!-)&,5 IS CONTRAINDICATED IN PATIENTS WHO HAVE HAD SEVERE ALLERGIC REACTIONS SUCH AS ANAPHYLAXIS OR SERIOUS SKIN REACTIONS
SUCH AS TOXIC EPIDERMAL NECROLYSIS 3TEVENS
*OHNSON SYNDROME OR ERYTHEMA MULTIFORME TO ANY COMPONENT OF 4!-)&,5
#ASES OF THESE EVENTS HAVE BEEN REPORTED IN POSTMARKETING EXPERIENCE WITH 4!-)&,5 4AMImU SHOULD BE STOPPED AND
APPROPRIATE TREATMENT INSTITUTED IF AN ALLERGIC
LIKE REACTION OCCURS OR IS SUSPECTED
4HERE 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 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. If neuropsychiatric
SYMPTOMS OCCUR THE RISKS AND BENElTS OF CONTINUING TREATMENT SHOULD BE EVALUATED FOR EACH PATIENT
3ERIOUS BACTERIAL INFECTIONS MAY BEGIN WITH INmUENZA
LIKE SYMPTOMS OR MAY CO
EXIST WITH OR OCCUR AS COMPLICATIONS DURING
the course of influenza. TAMIFLU has not been shown to prevent such complications.
%FlCACY IN SUBJECTS WITH CHRONIC CARDIAC ANDOR RESPIRATORY DISEASE OR IN IMMUNOCOMPROMISED PATIENTS HAS NOT BEEN
ESTABLISHED .O INFORMATION IS AVAILABLE REGARDING TREATMENT OF INmUENZA IN PATIENTS AT IMMINENT RISK OF REQUIRING HOSPITALIZATION
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 ,!)6 SHOULD NOT BE ADMINISTERED WITHIN WEEKS BEFORE OR
HOURS AFTER ADMINISTRATION OF 4!-)&,5 UNLESS MEDICALLY INDICATED
!DVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN PATIENTS TREATED WITH 4!-)&,5 THAN IN PATIENTS TAKING PLACEBO AND OCCURRED
in 2% of patients were (TAMIFLU%, placebo %):
4REATMENT IN ADULTS n NAUSEA VOMITING BRONCHITIS
4REATMENT IN PEDIATRICS n VOMITING ABDOMINAL PAIN EPISTAXIS EAR DISORDER
0ROPHYLAXIS OF ADULTS n HEADACHE NAUSEA DIARRHEA VOMITING ABDOMINAL
pain (2%, 1%)
Prophylaxis of pediatrics – vomiting (10%, 2%), abdominal pain (3%, 0%), nausea (4%, 1%)
