No.9- Isattuximab- (SARCLISA)--(Feb 2020)

 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Infusion-Related Reaction-                                                                                                   Instruct patients to immediately report any occurrence of symptoms occurring within 24 hours of start of infusion to their healthcare provider 

Neutropenia-                                                                                                                              Inform patients about the risk of neutropenia and infection during SARCLISA treatment and the importance of reporting immediately any fever or symptoms of infection to their healthcare provider 

Second Primary Malignancies-                                                                                             Inform patients of the risk of developing second primary malignancies during treatment with SARCLISA in combination with pomalidomide and low-dose dexamethasone. 

Interference with Laboratory Tests -                                                                                      Advise patients to inform healthcare providers and transfusion center personnel that they are treated with SARCLISA in case a red blood cell transfusion is planned

Embryo-Fetal Toxicity-                                                                                                                 Advise women of the potential hazard to a fetus and to avoid becoming pregnant during treatment and for at least 5 months after the last dose of SARCLISA

Advise patients that pomalidomide has the potential to cause fetal harm and has specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm.

Advise patients to report suspected or known pregnancies. Pomalidomide is only available through a REMS program

Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A SANOFI COMPANY U.S. License No. 1752 SARCLISA is a registered trademark of Sanofi ©2020 sanofi-aventis U.S. LLC