Kadcyla and Compatibility of Filters

This article responds to your request for information on Kadcyla® (trastuzumab emtansine) and the compatibility of filters.

 

Please refer to the locally approved storage information provided in the Kadcyla package insert or prescribing information. Any deviation from this information is considered off-label and any treatment decisions based on such deviations are the full responsibility of the prescribing physician.

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Last updated December 03, 2023

Recommendation for the use of a PES filter

If Kadcyla was diluted in an infusion bag containing 0.9% NaCl solution, a 0.2 or 0.22 µm polyethersulfone (PES) in-line filter is required for administration to remove potential particulates that may occur in storage.[1]

While not required, a 0.2 or 0.22 µm PES in-line filter can be used during administration if Kadcyla was diluted in an infusion bag containing 0.45% NaCl solution.

Using other filters

Roche only recommends the use of a 0.2 or 0.22 µm PES in-line filter with Kadcyla. The use of a different filter would be off-label and a clinical decision to be made by the physician after an analysis of the benefit-risk ratio.

Further studies have demonstrated compatibility of diluted Kadcyla solution with 

  • 0.2 µm polysulphone (PSU) in-line filters (Terumo PB infusion line), [1] and
    • 0.2 µm nylon (positively charged Nylon Posidyne® membrane) in-line filters.[2]

      No data are available for the compatibility of diluted Kadcyla solutions with

          
      • polyvinyl chloride (PVC) in-line filters, or
        • in-line filters with a pore size of >0.22 µm.[3]

          References

          1. Roche Internal Technical Report (TEC-0148930). Accessed 12 July 2023.
            1. Roche Internal Technical Report (TEC-0169327). Accessed 12 July 2023.
              1. Roche Internal Communications. Accessed 25 July 2023.

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