Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9176a |
| Trade Name | Dose Form | Strength | Identifier |
| Kadcyla | Powder for infusion | 160 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Roche Products (NZ) Ltd P O Box 109113 Newmarket Auckland 1149 | 12/12/2012 | Consent given Approval date: 26/9/2013 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| powder for infusion | Active | |
| Trastuzumab emtansine 160mg (plus 7% vial overfill = trastuzumab emtansine 171mg) | Lonza Ltd Lonzastrasse VISP CH-3930 Switzerland | |
| Excipient | ||
| Polysorbate 20 | ||
| Sodium hydroxide | ||
| Succinic acid | ||
| Sucrose |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | F Hoffmann-La Roche Ltd Betriebsstatten Kaiseraugst Wurmisweg Kaiseraugst CH-4303 Switzerland |
| Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim D-68305 Germany | |
| Manufacture of Final Dose Form | F Hoffmann-La Roche Ltd Betriebsstatten Kaiseraugst Wurmisweg Kaiseraugst CH-4303 Switzerland |
| Manufacture of Intermediate Product | Lonza Ltd Lonzastrasse VISP CH-3930 Switzerland |
| Secondary Packaging | F Hoffmann-La Roche Ltd Betriebsstatten Kaiseraugst Wurmisweg Kaiseraugst CH-4303 Switzerland |
| NZ Site of Product Release | Roche Products (NZ) Ltd 98 Carlton Gore Road Newmarket Auckland 1023 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, single dose, Rubber stopper | 160 mg | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) |
Indications
Kadcyla as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.
Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included HER2-targeted therapy.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 24/1/2023 | Self-Assessable Change Notification | Active ingredient method of manufacture - G1 (Self assessable) | Notified | 31/1/2023 | |
| 12/12/2012 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances; Additional strength - Grade 1 | Granted 26/9/2013 | 31/12/2012 | Y |
