Label Changes for:
Relenza (zanamivir) inhalation powder
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
- 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
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
- Neurologic:vasovagal-like episodes have been reported shortly following inhalation of zanamivir.