Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
Enhertu 100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White to yellowish-white lyophilised powder. |
One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab deruxtecan. After reconstitution, one vial of 5 mL solution contains 20 mg/mL of trastuzumab deruxtecan (see section 6.6).
Trastuzumab deruxtecan is an antibody-drug conjugate (ADC) that contains a humanised anti-HER2 IgG1 monoclonal antibody (mAb) with the same amino acid sequence as trastuzumab, produced by mammalian (Chinese Hamster Ovary) cells, covalently linked to DXd, an exatecan derivative and a topoisomerase I inhibitor, via a tetrapeptide-based cleavable linker. Approximately 8 molecules of deruxtecan are attached to each antibody molecule.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Trastuzumab deruxtecan |
Trastuzumab deruxtecan is a HER2-targeted antibody-drug conjugate. The antibody is a humanised anti-HER2 IgG1 attached to deruxtecan, a topoisomerase I inhibitor (DXd) bound by a tetrapeptide-based cleavable linker. |
| List of Excipients |
|---|
|
L-histidine |
Enhertu is provided in 10 mL Type 1 amber borosilicate glass vial sealed with a fluoro-resin laminated butyl rubber stopper, and a polypropylene/aluminium yellow flip-off crimp cap. Each carton contains 1 vial.
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
EU/1/20/1508/001
Date of first authorisation: 18 January 2021
Date of latest renewal: 12 November 2021
| Drug | Countries | |
|---|---|---|
| ENHERTU | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States |
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