This brand name is authorized in Austria, Brazil, Canada, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States
The drug SARCLISA contains one active pharmaceutical ingredient (API):
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1
Isatuximab
UNII R30772KCU0 - ISATUXIMAB
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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). |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| SARCLISA Concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC | |
| SARCLISA Concentrate solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L01FC02 | Isatuximab | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FC CD38 (Clusters of Differentiation 38) inhibitors |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 576721070094602, 576721070094702 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02498235, 02498243 |
| Country: EE | Ravimiamet | Identifier(s): 1821024, 1821035, 1821046 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 133049, 458904 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 66510210 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 387145, 387148 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 048617017, 048617029, 048617031 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 4291454A1021, 4291454A2028 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1090347, 1090348, 1090349 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 204293, 204307 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100434592 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W69367001, W69367002, W69367003 |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699809779259, 8699809779266 |
| Country: US | FDA, National Drug Code | Identifier(s): 0024-0654, 0024-0656 |
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