Kadcyla Storage Recommendations
This article responds to your request for information on Kadcyla® (trastuzumab emtansine) and storage recommendations.
Last updated December 04, 2023
Recommendations for Kadcyla storage temperature
Unopened vial
Kadcyla vials should be stored at 2°C to 8°C.[1]
If Kadcyla was inadvertantly stored outside of this temperature range, a stability assessment can be requested through medinfo.roche.com.
Reconstituted solution
Kadcyla vials reconstituted with sterile water for injection should be used immediately following reconstitution.[1] If not used immediately, the reconstituted vials can be stored for up to 24 hours at 2°C to 8°C and must be discarded thereafter.
Do not freeze the reconstituted solution.
Infusion bag containing the diluted solution
The reconstituted Kadcyla solution diluted in 0.9% NaCl Injection, or 0.45% NaCl Injection, may be stored at 2°C to 8°C for up to 24 hours prior to use.[1]
Do not freeze the solution for infusion containing the reconstituted product.
Recommendation for Kadcyla light protection
Avoid exposing Kadcyla to direct daylight in all forms, including in the unopened vial, reconstituted solution, and diluted infusion bag.[2] Handling of Kadcyla in ambient light conditions is acceptable. Refer to the locally approved prescribing information for any additional storage recommendations.[2]
References
1. Roche Internal Regulatory Report. Accessed 12 July 2023.
2. Roche Internal Communications. Accessed 25 July 2023.
Medinfo
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