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

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