Trastuzumab emtansine 160mg (ado‑trastuzumab emtansine; T‑DM1)
| Product Overview | |
| Generic Name | Trastuzumab emtansine 160mg (ado‑trastuzumab emtansine; T‑DM1) |
| Brand Name(s) | Kadcyla® |
| Form | Sterile lyophilized powder for concentrate for infusion (single‑dose vial) |
| Strength | 160 mg |
| Therapeutic Class | HER2‑targeted antibody‑drug conjugate (trastuzumab linked to DM1, a tubulin inhibitor) |
| ATC Code | L01XC14 |
| Manufacturing & Regulatory | |
| Manufacturer | Developed by Genentech/Roche; manufactured by Lonza |
| Country | in multiple countries (Lonza: Switzerland/US) |
| GMP Compliance | Biologic GMP-compliant manufacturing |
| DMF/CEP | Controlled entry under FDA/EMA |
| COFEPRIS | Not found in public sources |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Refrigerate 2 °C to 8 °C until reconstitution; do not freeze or shake |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | provided by manufacturer/distributor upon order |
| SDS | available from manufacturer/distributor upon request |
| CTD Summary | CTD dossier available from Roche; |
Description
Trastuzumab emtansine (Kadcyla®) is indicated for the treatment of HER2‑positive metastatic breast cancer in adult patients who previously received trastuzumab and a taxane, separately or in combination. Also indicated as adjuvant therapy for patients with residual invasive disease after neoadjuvant taxane and trastuzumab therapy,
