Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Kadcyla 100 mg powder for concentrate for solution for infusion.
Kadcyla 160 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Powder for concentrate for solution for infusion. White to off-white lyophilised powder. |
Kadcyla 100 mg powder for concentrate for solution for infusion: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine. After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Kadcyla 160 mg powder for concentrate for solution for infusion: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine. After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Trastuzumab emtansine |
Trastuzumab emtansine is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumour cells, thereby increasing intracellular delivery of DM1 directly to malignant cells. |
| List of Excipients |
|---|
|
Succinic acid |
Kadcyla 100 mg powder for concentrate for solution for infusion: Kadcyla is provided in 15 mL (100 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro-resin laminate, and sealed with an aluminium seal with a white plastic flip-off cap.
Pack of 1 vial.
Kadcyla 160 mg powder for concentrate for solution for infusion: Kadcyla is provided in 20 mL (160 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro resin laminate, and sealed with an aluminium seal with a purple plastic flip-off cap.
Pack of 1 vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/13/885/001
EU/1/13/885/002
Date of first authorisation: 15 November 2013
Date of latest renewal: 17 September 2018
| Drug | Countries | |
|---|---|---|
| KADCYLA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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