SARCLISA + Pd (ICARIA-MM): ADDITIONAL SAFETY INFORMATION

Additional safety information for SARCLISA + Pd1

INFECTIONS

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

INTERACTIONS

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

IMMUNOGENICITY

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

PREGNANCY, BREAST-FEEDING AND FERTILITY

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

You are now leaving the https://sarclisa.co.uk website.

By clicking on this link, you will be leaving this Sanofi hosted website, and, depending on the link, will be redirected to either another Sanofi website (for example, to view the Sanofi Privacy Policy) or an independent third-party website.
Sanofi has no control over the content or availability of third-party sites or resources that are linked to, and accepts no liability or responsibility for them or for any loss or damage that may arise from your use of them. The existence of a link between this website and any third party site or resource in no way implies that Sanofi in any way approves of the content of these sites or resources, or any use to which such content maybe put.

Please ensure that you read the legal and privacy policy sections of any website to which you link.

CONTINUE