Generic Name: isatuximab-irfc
Drug Class: Targeted Therapy Medications
Company: Sanofi-Aventis
Approval Status: Approved
Generic Version Available: No
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