Skip to Content

Label Changes for:

Relenza (zanamivir) inhalation powder

December 2011

Changes have been made to the CONTRAINDICATIONS and PATIENT PACKAGE INSERT sections of the safety label.

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


December 2011



  • 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 are allergic to...milk proteins


December 2010


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.