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U.S. Department of Health and Human Services


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Relenza (zanamivir) inhalation powder

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010 and December 2011


December 2011

Summary View



  • Do not use in patients with history of allergic reaction to any ingredient of Relenza including milk proteins.



Who should not take RELENZA?
  • Also tell your healthcare provider if...you are allergic to...milk proteins


December 2010

Summary View


WARNINGS and Precautions

Importance of Proper Route of Administration
  • Relenza Inhalation Powder must not be made into an extemporaneous solution for administration by nebulization or mechanical ventilation. There have been reports of hospitalized patients with influenza who received a solution made with Relenza Inhalation Powder administered by nebulization or mechanical ventilation, including a fatal case where it was reported that the lactose in this formulation obstructed the proper functioning of the equipment. Relenza Inhalation Powder must only be administered using the device provided


Postmarketing Experience
  • Neurologic:vasovagal-like episodes have been reported shortly following inhalation of zanamivir.