Additional safety information for SARCLISA + Pd1


A higher incidence of infections including grade ≥3 infections, mainly pneumonia, upper respiratory tract infection and bronchitis, occurred with SARCLISA + Pd. Incidence of grade 3 or higher infections was 42.8%.1

Pneumonia was the most commonly reported severe infection:1

Discontinuations from treatment due to infection were reported in 2.6% of patients treated with SARCLISA + Pd vs. 5.4% for Pd alone. Fatal infections were reported in 3.3% of patients treated with SARCLISA + Pd vs. 4.0% for Pd alone.1

Patients receiving SARCLISA should be closely monitored for signs of infection and appropriate standard therapy instituted. Antibiotics and antiviral prophylaxis can be considered during treatment.1


SARCLISA has no impact on the pharmacokinetics (PK) of pomalidomide and vice versa.1

SARCLISA binds to CD38 on red blood cells (RBCs) and may result in a false positive indirect antiglobulin test (indirect Coombs test).1

SARCLISA may be detected by serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the monitoring of M-protein, and could interfere with accurate response classification.1


Anti-drug antibodies (ADA) were detected in 2.3% of patients across 6 clinical studies in MM with SARCLISA single agent and combination therapies including ICARIA-MM (N=564). No effect of ADAs was observed on pharmacokinetics, safety or efficacy of SARCLISA.1


Women of childbearing potential treated with SARCLISA should use effective contraception during treatment and for 5 months after cessation of treatment. There are no available data on SARCLISA use in pregnant women. The use of SARCLISA in pregnant women is not recommended.1

It is unknown whether SARCLISA is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; however, a risk to the breast-fed child cannot be excluded during this short period just after birth.1

No human and animal data are available to determine potential effects of SARCLISA on fertility in males and females.1

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