Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9176a
Trade NameDose FormStrengthIdentifier
Kadcyla Powder for infusion160 mg
SponsorApplication dateRegistration situationClassification
Roche Products (NZ) Ltd
P O Box 109113
Newmarket
Auckland 1149
12/12/2012Consent given
Approval date: 26/9/2013
Prescription
 

Composition

ComponentIngredientManufacturer
powder for infusionActive 
 Trastuzumab emtansine 160 mg (plus 7% vial overfill = trastuzumab emtansine 171mg)Lonza Ltd
Lonzastrasse
VISP CH-3930
Switzerland
 Excipient 
 Polysorbate 20
 Sodium hydroxide
 Succinic acid
 Sucrose

Production

Manufacturing stepManufacturer
Finished Product TestingF Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
Switzerland
 Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim D-68305
Germany
 Roche Pharma AG
Emil-Barell Strasse 1
Grenzach-Wyhlen D-79639
Germany
Manufacture of Final Dose FormF Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
Switzerland
 Patheon Manufacturing Services LLC
5900 Martin Luther King Jr Highway
Greenville
North Carolina 27834
United States of America
Manufacture of Intermediate ProductLonza Ltd
Lonzastrasse
VISP CH-3930
Switzerland
PackingPatheon Manufacturing Services LLC
5900 Martin Luther King Jr Highway
Greenville
North Carolina 27834
United States of America
Secondary PackagingF Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
Switzerland
NZ Site of Product ReleaseRoche Products (NZ) Ltd
98 Carlton Gore Road
Newmarket
Auckland 1023

Packaging

PackageContentsShelf Life
Vial, glass, single dose, Rubber stopper160 mg36 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 DateApplication TypeChange(s)StatusPayment DatePriority
8/5/2020Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified11/5/2020 
12/12/2012New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substances; Additional strength - Grade 1Granted 26/9/201331/12/2012Y
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /