SARCLISA

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, UK.

Active ingredients

The drug SARCLISA contains one active pharmaceutical ingredient (API):

1
UNII R30772KCU0 - 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).

 
Read more about Isatuximab

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 SARCLISA Concentrate for solution for infusion MPI, EU: SmPC European Medicines Agency (EU)
 SARCLISA Concentrate solution for injection MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group 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
Discover more medicines within L01FC02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
BR Câmara de Regulação do Mercado de Medicamentos 576721070094602, 576721070094702
CA Health Products and Food Branch 02498235, 02498243
EE Ravimiamet 1821024, 1821035, 1821046
FI Lääkealan turvallisuus- ja kehittämiskeskus 133049, 458904
FR Base de données publique des médicaments 66510210
GB Medicines & Healthcare Products Regulatory Agency 387145, 387148
IT Agenzia del Farmaco 048617017, 048617029, 048617031
JP 医薬品医療機器総合機構 4291454A1021, 4291454A2028
LT Valstybinė vaistų kontrolės tarnyba 1090347, 1090348, 1090349
NL Z-Index G-Standaard, PRK 204293, 204307
PL Rejestru Produktów Leczniczych 100434592
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W69367001, W69367002, W69367003
TR İlaç ve Tıbbi Cihaz Kurumu 8699809779259, 8699809779266
US FDA, National Drug Code 0024-0654, 0024-0656

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