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CARVYKTI - Administration Using a Non-Leukocyte Depleting Filter

Last Updated: 11/25/2024

SUMMARY  

  • The Prescribing Information should be the source document for administration procedures.
  • CARVYKTI must be administered using infusion sets fitted with an in-line filter. Do NOT use a leukocyte-depleting filter.1
  • A non-leukocyte depleting filter is commonly referred to as a blood filter. All blood and cell products must be administered through a filter in order to remove cell clots and thrombi. Standard blood filters, with a pore size of 170–260 μm, trap large aggregates and clots.2
  • CARVYKTI is an engineered T cell product derived from a patient’s blood and therefore has been developed to follow standard practices of administration as a blood and cell product. To ensure the engineered T cells are not filtered out during infusion, while preventing potential agglomerates and clots of material from being infused to the patient, a non-leukocyte depleting filter (blood filter) must be used. If agglomerates/thrombi enter the bloodstream, there is a potential for the formation of clots, which can lead to pulmonary embolism.2
  • In the CARTITUDE-1 study, CARVYKTI was administered using an infusion set with a blood filter with a pore size of 170 μm or larger.3
  • Blood filters are also available as microagglomerate filters which have a pore size range of 10–40 μm. CARVYKTI has not been evaluated for administration with microagglomerate filters and therefore they must NOT be used during infusion.2

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 20 November 2024.

 

References

1 CARVYKTI (ciltacabtagene autoleucel) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf
2 CARVYKTI® (ciltacabtagene autoleucel) Product Handling Guide. Published April 2024. Accessed November 20, 2024. Horsham, PA: Janssen Biotech, Inc.  
3 Data on File. Janssen Research & Development, LLC., IPPI JNJ 68284528 TV-TEC-133339_v9.0. January 2021.