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TAMIFLU® (oseltamivir phosphate) Product Information
TAMIFLU® (oseltamivir phosphate) is prescribed for treating adults and children age 1 year and older with influenza (flu) whose symptoms started within the last day or two. TAMIFLU can also reduce the chance of getting the flu in patients 1 year and older. TAMIFLU is not a substitute for the annual flu vaccinations (patients should still get the flu shot every year).
Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age 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
- Efficacy of Tamiflu in patients who begin treatment after 48 hours of symptoms has not been established
- Tamiflu is not a substitute for early and annual influenza vaccination
- 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
Important Safety Information
- Tamiflu is contraindicated in patients with known serious hypersensitivity to Tamiflu or any component of the product
- Serious Skin/Hypersensitivity Reactions: cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme have been reported in postmarketing experience with Tamiflu
- 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
- Bacterial Infections: serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza
- Limitations of Populations Studied: Tamiflu efficacy for influenza treatment has not been established for patients with chronic cardiac or respiratory disease, nor for immunocompromised patients or those with severe or unstable medical conditions that may require imminent hospitalization
- Concurrent Use with Live Attenuated Influenza Vaccine (LAIV): LAIV should not be administered within 2 weeks before or 48 hours after administration of Tamiflu
Adverse events that occurred more frequently in patients treated with Tamiflu than in patients taking placebo (frequency ≥ 2%) across clinical trials were nausea, vomiting, abdominal pain, ear disorder, and diarrhea.
The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of subjects aged 1 year and above, with vomiting, diarrhea and diaper rash 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.