Sarclisa Injection, Solution, Concentrate
Product Images NDC 0024-0656

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Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Sarclisa (NDC 0024-0656). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sanofi-aventis U.s. Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

Figure 1 (Sarclisa 01)

Figure 1 (Sarclisa 01)
This appears to be a statistical analysis of patients with Isa-Pd and Tsa-Pd Pd, with a comparison to a comparator regimen. The analysis includes a hazard ratio and median months of the patients at risk. There are also graphs displaying the probability of PFS over time.*
FDA Label Image

Principal Display Panel (100 mg/5 mL Vial Carton)

Principal Display Panel (100 mg/5 mL Vial Carton)
This is a table containing statistical data for two different types of treatment, namely Isa-Kd and Kd. The data suggests that Isa-Kd has a better median progression-free survival than Kd. Furthermore, the table includes the Hazard ratio (HR) and the confidence interval (CI) which indicate the reliability of the data. Patients' probability of PFS is also presented over time.*
FDA Label Image

Principal Display Panel (500 mg/25 mL Vial Carton)

Principal Display Panel (500 mg/25 mL Vial Carton)
SARCLISA is an isatuximab-irfc injection used for intravenous infusion. Each mL of solution contains 20 mg of isatuximab-fc along with other substances like histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injection. The prescribed dosage and administration procedure should be followed carefully. The vial must be stored refrigerated at 36°F-46°F, protected from light, not shaken, and not frozen. SARCLISA is manufactured by Sanofi-aventis US, LLC and should be used only as per standard medical guidelines.*
FDA Label Image

Sarclisa 04

Sarclisa 04
SARCLISA (isatuximab-irfc) Injection is a medication administered through the intravenous route, for which one 25mL single-dose vial is sufficient. It is produced and distributed by Sanofiaventis US, LLC. SARCLISA comes in doses of 500mg/25mL or 20mg/mL, and it should be stored in the refrigerator at 2-8°C to protect it from light. It is important not to shake or freeze the medication. SARCLISA's dosage and administration processes must be done as per the prescribing information. The preparation is not suitable for children, and once it is no longer required or has passed the expiration date, the unused portion should be disposed of. The contents of the vial contain the active Isatuximab-rc ingredient (20mg/mL) and other additives necessary for the preparation. The text does not provide information about the medical conditions for which SARCLISA is suitable.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.