Label: SARCLISA- isatuximab injection, solution, concentrate

  • NDC Code(s): 0024-0654-01, 0024-0656-01
  • Packager: Sanofi-Aventis U.S. LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 16, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use SARCLISA safely and effectively. See full prescribing information for SARCLISA. SARCLISA® (isatuximab-irfc) injection, for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - Administer pre-infusion medications [see Dosage and Administration (2.2)]. SARCLISA should be administered by a healthcare professional, with immediate access to ...
  • 3 DOSAGE FORMS AND STRENGTHS
    SARCLISA is a clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particulates available as: Injection: 100 mg/5 mL (20 mg/mL) in a single-dose ...
  • 4 CONTRAINDICATIONS
    SARCLISA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients [see Warnings and Precautions (5.1)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Infusion-Related Reactions - Serious infusion-related reactions including life-threatening anaphylactic reactions have occurred with SARCLISA treatment. Severe signs and symptoms included ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions from SARCLISA are also described in other sections of the labeling: Infusion-Related Reactions [see Warnings and Precautions ...
  • 7 DRUG INTERACTIONS
    7.1 Laboratory Test Interference - Interference with Serological Testing - SARCLISA, an anti-CD38 antibody, may interfere with blood bank serologic tests with false positive reactions in ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - SARCLISA can cause fetal harm when administered to a pregnant woman. The assessment of isatuximab-irfc-associated risks is based on the mechanism of action and ...
  • 11 DESCRIPTION
    Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Isatuximab-irfc is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity and genotoxicity studies have not been conducted with isatuximab-irfc. Fertility studies have not been conducted with ...
  • 14 CLINICAL STUDIES
    Relapsed and/or Refractory Multiple Myeloma - ICARIA-MM - The efficacy and safety of SARCLISA in combination with pomalidomide and dexamethasone (Isa-Pd) were evaluated in ICARIA-MM ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - SARCLISA (isatuximab-irfc) injection is a clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particulates, supplied as follows: One ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Infusion-Related Reaction - Advise patients to seek immediate medical attention for any of the following ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: sanofi-aventis U.S. LLC - Morristown, NJ 07960 - A SANOFI COMPANY - U.S. License No. 1752 - SARCLISA is a registered trademark of Sanofi - ©2025 sanofi-aventis U.S. LLC
  • PATIENT PACKAGE INSERT
    This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: 06/2025 - Patient Information - SARCLISA® (sar-cli-sa) (isatuximab-irfc) injection - SARCLISA ...
  • PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Carton
    NDC 0024-0654-01 - Rx only - SARCLISA® (isatuximab-irfc) Injection - 100 mg/5 mL (20 mg/mL) For Intravenous Infusion After Dilution - One single-dose vial - Discard unused portion - sanofi
  • PRINCIPAL DISPLAY PANEL - 500 mg/25 mL Vial Carton
    NDC 0024-0656-01 - Rx only - SARCLISA® (isatuximab-irfc) Injection - 500 mg/25 mL (20 mg/mL) For Intravenous Infusion After Dilution - One single-dose vial - Discard unused portion - sanofi
  • INGREDIENTS AND APPEARANCE
    Product Information