Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
SARCLISA 20mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Colourless to slightly yellow solution, essentially free of visible particulates. |
One ml of concentrate for solution for infusion contains 20 mg of isatuximab.
Each vial contains 100 mg of isatuximab in 5 mL of concentrate (100 mg/5mL).
Each vial contains 500 mg of isatuximab in 25 mL of concentrate (500 mg/25mL).
Isatuximab is an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) produced from a mammalian cell line (Chinese Hamster Ovary, CHO).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Isatuximab |
Isatuximab is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). It is used in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM). |
| List of Excipients |
|---|
|
Sucrose |
5 ml concentrate containing 100 mg of isatuximab in a 6 mL type I colourless clear glass vial closed with ETFE (copolymer of ethylene and tetrafluoroethylene)-coated bromobutyl stopper. The vials are crimped with an aluminium seal with a grey flip-off button. The fill volume has been established to ensure removal of 5 mL (i.e. 5.4 mL). Pack size of one or three vials.
25 ml concentrate containing 500 mg of isatuximab in a 30 mL type I colourless clear glass vial closed with ETFE (copolymer of ethylene and tetrafluoroethylene)-coated bromobutyl stopper. The vials are crimped with an aluminium seal with a blue flip-off button. The fill volume has been established to ensure removal of 25 mL (i.e. 26 mL). Pack size of one vial.
Not all pack sizes may be marketed.
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
EU/1/20/1435/001
EU/1/20/1435/002
EU/1/20/1435/003
Date of first authorisation: 30 May 2020
| Drug | Countries | |
|---|---|---|
| SARCLISA | Austria, Brazil, Canada, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
