Medication Guide App

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

 

CONTRAINDICATIONS

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

 

PATIENT INFORMATION

Who should not take RELENZA?
  • Also tell your healthcare provider if...you 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

ADVERSE REACTIONS

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

 

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