TAMIFLU® (oseltamivir phosphate) has been studied only in strains of influenza that were circulating at the time. The magnitude of effect of TAMIFLU in treating and preventing novel strains of influenza, such as those that may be involved in a pandemic, cannot be predicted.
Store antivirals for your organization
It is important to consider where and how your organization will store the
supply of TAMIFLU it receives. TAMIFLU capsules are supplied in blister
packages of 10 (NDC 0004-0800-85). They are 75 mg grey/light yellow hard
gelatin capsules. "Roche" is printed in blue ink on the grey body, and "75
mg" is printed in blue ink on the light yellow cap. The following
checklist will help you to select a suitable storage site.
How Supplied
Each case contains 88 blisters.
Each pallet contains either 45 or 56 cases
depending on configuration.
The dimensions and weight case and pallet are as follows:
Case Configuration
Number of blister packs per case = 88
Length, width, depth
Configuration 1: 13.375"L x 10.125"W x 8.625"H
Configuration 2: 13.438"L x 8.875"W x 10.562"H
Pallet Configuration
Number of cases per pallet = 45 or 56
Length and width
40.5" x 48" = 56 cases
42" x 48" = 45 cases
Understand criteria for TAMIFLU storage An organization can store product at any entity that meets ALL of the following criteria:
Adheres to TAMIFLU product storage
requirements (see Package Insert)
Adheres to storage guidelines of United States Pharmacopeia (USP) www.usp.org
Has sufficient and appropriate storage based on order quantity and distribution plan
The entity must also meet these TAMIFLU storage requirements:
TAMIFLU capsules must be stored at 25º Celsius (77º Fahrenheit); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
Identify and contact entities and evaluate their capacity to store TAMIFLU for your organization In most cases, an organization can store product at any of the following locations:
Company warehouse or storage facility in
compliance with the aforementioned criteria
Pharmaceutical wholesaler
Specialty distributor
Pharmacy Benefit Manager
Company or community clinic
Physician's office
Notes:
- Other options may exist
- Not all companies will be able to store product
TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients 1 year and older who have been symptomatic for no more than 2 days.
TAMIFLU is also indicated for the prophylaxis of influenza in patients 1 year and older.
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).
Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.
Safety Information
There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.
Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.
No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization.
Efficacy of TAMIFLU has not been established in immunocompromised patients.
Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.
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. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.
The most common adverse events reported >1% of patients treated with TAMIFLU and more commonly than in patients treated with placebo are:
Treatment of adult and pediatric patients - nausea, vomiting.
Prophylaxis of adult and pediatric patients - nausea, vomiting, abdominal pain.
Vaccination is considered the first line of defense against influenza.
TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients 1 year and older who have been symptomatic for no more than 2 days.
TAMIFLU is also indicated for the prophylaxis of influenza in patients 1 year and older.
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).
Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.
Safety Information
There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.
Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.
No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization.
Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.
Efficacy of TAMIFLU has not been established in immunocompromised patients.
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. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.
The most common adverse events reported >1% of patients treated with TAMIFLU and more commonly than in patients treated with placebo are:
Treatment of adult and pediatric patients – nausea, vomiting.
Prophylaxis of adult and pediatric patients – nausea, vomiting, abdominal pain.
Vaccination is considered the first line of defense against influenza.
Understand criteria for TAMIFLU storage
