Polivy▼ and Transportation of Infusion Bag
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
This article responds to your request for information on Polivy® (polatuzumab-vedotin) and the need to remove air from the infusion bag before transportation.
Last updated September 08, 2023
Recommendations for transportation of Polivy infusion bag
Avoid transportation of the prepared solution for infusion as agitation stress can result in aggregation.[1] If the prepared infusion bag needs to be transported, then
- remove air from the infusion bag, and
- limit the time for transportation to administration site as stated in your local product label
Reason for removing the air from Polivy infusion bag before transportation
Polivy is an antibody-drug conjugate that contains an anti-CD79b monoclonal antibody conjugated to a cytotoxic drug via a protease cleavable linker.[2]
If air is not removed from the Polivy infusion bag, then the drug will be exposed to the air-liquid interface. As a result, the hydrophobic linker-drug component would preferentially accumulate at this air-liquid interface which could result in increased protein aggregation.[3,4]
References
- Roche Internal Regulatory Document (Polivy Core Data Sheet v3.0)(Accessed on 16 August 2023).
- Palanca-Wessels M, Czuczman M, Salles G, et al. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol 2015;16:704-15. https://www.ncbi.nlm.nih.gov/pubmed/25925619
- Roche Internal Technical Report (Accessed on 04 July 2023).
- Roche Internal Technical Report (Accessed on 04 July 2023).
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