Official Shelf Life for Kadcyla
Kadcyla (ado-trastuzumab emtansine), a refrigerated injectable for HER2-positive breast cancer, has a shelf life of 24 months when stored unopened at 2°C to 8°C (36°F to 46°F). Do not freeze or shake the vials.[1]
Unopened vs. Reconstituted Storage
Once reconstituted with sterile water, Kadcyla remains stable for 24 hours at 2°C to 8°C or up to 4 hours at room temperature (up to 25°C/77°F). Discard any unused portion after these times to avoid potency loss.[1][2]
What Affects Stability
Heat, light, and freezing degrade Kadcyla. Manufacturers recommend checking for particulate matter or discoloration before use. Travel packs exist for up to 30 days at room temperature under controlled conditions, but confirm with the label for specific lots.[1]
Handling Errors and Patient Tips
If exposed to temperatures above 8°C for over 72 hours cumulatively, discard the vial—do not return it to refrigeration. Patients should use cooler packs for transport and consult pharmacists for stability questions during shortages or delays.[2][3]
Regulatory and Manufacturer Updates
Genentech/Roche sets these guidelines per FDA labeling, last updated in package inserts as of 2023. No recent changes to core shelf life, but check lot-specific info via the healthcare provider or FDA database for recalls.[1]
[1]: FDA Kadcyla Label
[2]: Genentech Storage Guidelines
[3]: Drugs.com Kadcyla Stability