TAMIFLU is an influenza neuraminidase inhibitor (NAI) indicated for:

• Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)
• Prophylaxis of influenza A and B in patients 1 year and older. (1.2)

Limitations of Use:

• Not a substitute for annual influenza vaccination. (1.3)
• Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3)
• Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3)

Treatment of influenza (2.2)

• Adults and adolescents (13 years and older): 75 mg twice daily for 5 days
• Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days
• Pediatric patients 2 weeks to less than 1 year of age: 3mg/kg twice daily for 5 days
• Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg twice daily for 5 days (2.4)
• Renally impaired adult patients (creatinine clearance >10-30 mL/min): Reduce to 30 mg once daily for 5 days (2.4)
• ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after every hemodialysis cycle. Treatment duration not to exceed 5 days (2.4)
• ESRD patients on CAPD: Reduce to a single 30 mg dose immediately (2.4)

Prophylaxis of influenza (2.3)

• Adults and adolescents (13 years and older): 75 mg once daily for at least 10 days

  -

  Community outbreak: 75 mg once daily for up to 6 weeks

• Pediatric patients 1 to 12 years of age: Based on weight once daily for 10 days

  -

  Community outbreak: Based on weight once daily for up to 6 weeks

• Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg once daily (2.4)
• Renally impaired adult patients (creatinine clearance >10-30 mL/min): Reduce to 30 mg once every other day (2.4)
• ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after alternate hemodialysis cycles for the recommended duration of prophylaxis (2.4)
• ESRD patients on CAPD: Reduce to 30 mg immediately and then 30 mg once weekly for the recommended duration of prophylaxis (2.4)

Patients with known serious hypersensitivity to oseltamivir or any of the components of TAMIFLU (4)
WARNINGS AND PRECAUTIONS

• Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue TAMIFLU and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1)
• Neuropsychiatric events: Patients with influenza, including those receiving TAMIFLU, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. (5.2)

Most common adverse reactions (>1% and more common than with placebo):

• Treatment studies – Nausea, vomiting, headache. (6.1)
• Prophylaxis studies – Nausea, vomiting, headache, pain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Live attenuated influenza vaccine (LAIV), intranasal:

Avoid administration of LAIV within 2 weeks before or 48 hours after TAMIFLU use, unless medically indicated. (7)