Dosing Considerations

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RELENZA is for administration to the respiratory tract by oral inhalation only, using the DISKHALER device provided [see Warnings and Precautions (5.6)].

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The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation).

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Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible. If RELENZA is prescribed for children, it should be used only under adult supervision and instruction, and the supervising adult should first be instructed by a healthcare professional [see Patient Counseling Information (17)].

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Patients scheduled to use an inhaled bronchodilator at the same time as RELENZA should use their bronchodilator before taking RELENZA [see Patient Counseling Information (17)].

Treatment of Influenza

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The recommended dose of RELENZA for treatment of influenza in adults and pediatric patients aged 7 years and older is 10 mg twice daily (approximately 12 hours apart) for 5 days.

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Two doses should be taken on the first day of treatment whenever possible provided there is at least 2 hours between doses.

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On subsequent days, doses should be about 12 hours apart (e.g., morning and evening) at approximately the same time each day.

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The safety and efficacy of repeated treatment courses have not been studied.

Prophylaxis of Influenza

Household Setting

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The recommended dose of RELENZA for prophylaxis of influenza in adults and pediatric patients aged 5 years and older in a household setting is 10 mg once daily for 10 days.

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The dose should be administered at approximately the same time each day.

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There are no data on the effectiveness of prophylaxis with RELENZA in a household setting when initiated more than 1.5 days after the onset of signs or symptoms in the index case.

Community Outbreaks

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The recommended dose of RELENZA for prophylaxis of influenza in adults and adolescents in a community setting is 10 mg once daily for 28 days.

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The dose should be administered at approximately the same time each day.

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There are no data on the effectiveness of prophylaxis with RELENZA in a community outbreak when initiated more than 5 days after the outbreak was identified in the community.

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The safety and effectiveness of prophylaxis with RELENZA have not been evaluated for longer than 28 days’ duration.