Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Trodelvy 200 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. Off-white to yellowish powder. |
One vial of powder contains 200 mg sacituzumab govitecan.
After reconstitution, one mL of solution contains 10 mg sacituzumab govitecan.
Sacituzumab govitecan is a Trop-2-directed antibody-drug conjugate (ADC). Sacituzumab is a humanised monoclonal antibody (hRS7 IgG1Îș) that recognises Trop-2. The small molecule, SN-38, is a topoisomerase I inhibitor, which is covalently attached to the antibody by a hydrolysable linker. Approximately 7-8 molecules of SN-38 are attached to each antibody molecule.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sacituzumab govitecan |
Sacituzumab govitecan binds to Trop-2-expressing cancer cells and is internalised with the subsequent release of SN-38 from a hydrolysable linker. SN-38 interacts with topoisomerase I and prevents re-ligation of topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and cell death. |
| List of Excipients |
|---|
|
2-(N-morpholino)ethane sulfonic acid (MES) |
Type I colourless, clear glass 50 mL vial, with an elastomeric butyl stopper and sealed with an aluminum flip-off overseal containing 200 mg of sacituzumab govitecan.
Each pack contains one vial.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/21/1592/001
Date of first authorisation: 22 November 2021
| Drug | Countries | |
|---|---|---|
| TRODELVY | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, Turkey, United Kingdom, United States |
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