Generic Name: isatuximab-irfc

Pronunciation: N/A

Abbreviation: N/A

Other Market Name: N/A

Drug Class: Targeted Therapy Medications

Company: Sanofi-Aventis

Approval Status: Approved

Generic Version Available: No

Experimental Code: N/A


Drug Indication

Sarclisa is a CD38 inhibitor approved for combination treatment of multiple myeloma in previously treated people.


General Info

Sarclisa is a cytolytic (cell-killing) antibody that binds to the CD38 protein on myeloma cells and helps the immune system recognize and attack the cancer. It is approved for use in combination with Pomalyst (pomalidomide) or Kyprolis (carfilzomib) and dexamethasone in adults who have received prior therapies.

In the ICARIA-MM trial of patients with relapsed or refractory (nonresponsive) multiple myeloma, Sarclisa plus Pomalyst and low-dose dexamethasone reduced the risk of disease progression or death by 40%. The IKEMA study showed that Sarclisa plus Kyprolis (carfilzomib) and dexamethasone reduced risk of disease progression or death by 45%. Sarclisa was first approved in March 2020.


Dosage

Dosing Info:

Sarclisa is administered as an intravenous infusion every week for four weeks, then every two weeks until disease progression or unacceptable side effects occur.


Side Effects

Common side effects include infusion reactions, upper respiratory tract infections, pneumonia, and diarrhea. Sarclisa can cause depletion of white blood cells (neutropenia and lymphopenia), red blood cells (anemia) and platelets (thrombocytopenia), which can lead to infections, fatigue and easy bleeding. More serious adverse events may include severe infusion reactions and new malignancies. Sarclisa may cause fetal harm if used during pregnancy.


For More Info: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf

Last Reviewed: April 5, 2021