Isatuximab

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. Isatuximab-irfc induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC).

• 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 lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.ICD-10: C90.00

• SARCLISA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients [see Warnings and Precautions (5.1) ] . Patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.contraindicated

Premedicate with dexamethasone, acetaminophen, H2 antagonists, and diphenhydramine. ( 2.2 ) The recommended dosage of SARCLISA is 10 mg/kg as an intravenous infusion. See full prescribing information for SARCLISA schedules of administration and drugs used in combination. ( 2.1 ) 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 emergency equipment and appropriate medical support to manage infusion-related reactions if they occur [see Warnings and Precautions (5.1) ] . The recommended dose of SARCLISA is 10 mg/kg actual body weight administered as an intravenous infusion in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone, or in combination with bortezomib, lenalidomide, and dexamethasone. SARCLISA dosing schedules are provided in Tables 1 and 2 [see Clinical Studies (14) ] .

Infusion-Related Reactions : In case of grade ≥2, interrupt SARCLISA and manage medically. Permanently discontinue for grade 4 infusion-related reactions or anaphylactic reaction. ( 5.1 ) Infections : SARCLISA can cause serious and fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately. ( 5.2 ) Neutropenia : Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. SARCLISA dose delays and the use of colony-stimulating factor may be required to allow improvement of neutrophil count. ( 5.3 ) Second Primary Malignancies (SPM) : Monitor patients for the development of second primary malignancies. ( 5.4 ) Laboratory Test Interference : Interference with Serological Testing (Indirect Antiglobulin Test): Type and screen patients prior to starting treatment. Inform blood banks that a patient has received SARCLISA. ( 5.5 , 7.1 ) Interference with Serum Protein Electrophoresis and Immunofixation Tests: SARCLISA may interfere with the assays used to monitor M-protein, which may impact the determination of complete response. ( 5.5 , 7.1 ) Embryo-Fetal Toxicity : Can cause fetal harm. ( 5.6 ) 5.1 Infusion-Related Reactions Serious infusion-related reactions including life-threatening anaphylactic reactions have occurred with SARCLISA treatment. Severe signs and symptoms included cardiac arrest, hypertension, hypotension, bronchospasm, dyspnea, angioedema, and swelling.

The following clinically significant adverse reactions from SARCLISA are also described in other sections of the labeling: Infusion-Related Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Neutropenia [see Warnings and Precautions (5.3) ] Second Primary Malignancies [see Warnings and Precautions (5.4) ] In combination with pomalidomide and dexamethasone : The most common adverse reactions (≥20%) are upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea. The most common hematology laboratory abnormalities (≥80%) are decreased hemoglobin, decreased neutrophils, decreased lymphocytes, and decreased platelets. ( 6.1 ) In combination with carfilzomib and dexamethasone : The most common adverse reactions (≥20%) are upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain. The most common hematology laboratory abnormalities (≥80%) are decreased hemoglobin, decreased lymphocytes, and decreased platelets. ( 6.1 ) In combination with bortezomib, lenalidomide and dexamethasone : The most common adverse reactions (≥20%) are upper respiratory tract infections, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19.

Lactation : Advise not to breastfeed. ( 8.2 ) 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 data from target antigen CD38 knockout animal models (see Data ). There are no available data on SARCLISA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction toxicity studies have not been conducted with isatuximab-irfc. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The combination of SARCLISA and pomalidomide or lenalidomide is contraindicated in pregnant women because pomalidomide and lenalidomide may cause birth defects and death of the unborn child. Refer to the pomalidomide or lenalidomide prescribing information on use during pregnancy. Pomalidomide and lenalidomide are only available through a REMS program.

Metabolism

Following administration of isatuximab-irfc in combination with pomalidomide and dexamethasone at the recommended dose and schedule, the steady-state mean (CV%) predicted maximum plasma concentration (C max ) and area under the plasma concentration-time curve (AUC) of isatuximab-irfc were 351 µg/mL (36.0%) and 72,600 µg∙h/mL (51.7%), respectively.

• Mar 2, 2020BLABLA761113Sanofi Aventis Us

1. 1Neutropenia4909.3%
2. 2Pneumonia3596.8%
3. 3Plasma Cell Myeloma3476.6%
4. 4Thrombocytopenia2975.6%
5. 5Covid-192895.5%
6. 6Pyrexia2615.0%
7. 7Anaemia2594.9%
8. 8Infusion Related Reaction2494.7%
9. 9Diarrhoea2284.3%
10. 10Off Label Use2063.9%
11. 11Dyspnoea1923.7%
12. 12Nausea1573.0%
13. 13Acute Kidney Injury1502.9%
14. 14Death1492.8%
15. 15Drug Ineffective1382.6%

The 10 most recently updated of 102 ClinicalTrials.gov registrations naming Isatuximab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Phase Ib Study of SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma
  Completed · Phase 1 · Interventional · 83 enrolled · Thomas Martin, MD
  NCT02332850updated 2026-06-11
• Horizon Two: HR NDMM (MMRC-100)
  Recruiting · Phase 2 · Interventional · 300 enrolled · Multiple Myeloma Research Consortium
  NCT07053436updated 2026-06-10
• Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
  Active not recruiting · Phase 2 · Interventional · 6 enrolled · UNC Lineberger Comprehensive Cancer Center
  NCT05911321updated 2026-06-09
• Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
  Recruiting · Phase 2 · Interventional · 61 enrolled · M.D. Anderson Cancer Center
  NCT05776979updated 2026-06-08
• Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma
  Not yet recruiting · Phase 3 · Interventional · 720 enrolled · Dana-Farber Cancer Institute
  NCT07624513updated 2026-06-03
• KRDI in Transplant-Eligible MM
  Active not recruiting · Phase 2 · Interventional · 50 enrolled · Massachusetts General Hospital
  NCT04430894updated 2026-06-03
• Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
  Recruiting · Phase 2 · Interventional · 50 enrolled · UNC Lineberger Comprehensive Cancer Center
  NCT05145400updated 2026-06-02
• Phase 1b/2: Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible/Deferred Newly Diagnosed Myeloma
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 88 enrolled · Dana-Farber Cancer Institute
  NCT07601100updated 2026-06-01
• Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma
  Active not recruiting · Phase 1 · Interventional · 3 enrolled · Elvira Umyarova
  NCT06203912updated 2026-05-26
• Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 220 enrolled · Universitätsklinikum Hamburg-Eppendorf
  NCT07600151updated 2026-05-20

Frequently asked questions

How does Isatuximab work?

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. Isatuximab-irfc induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC).

What is Isatuximab used for?

According to FDA labeling, Isatuximab carries indications including: 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 lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Isatuximab?

Isatuximab is classified as CD38 (Clusters of Differentiation 38) inhibitors, CD38-directed Cytolytic Antibody, CD38-directed Antibody Interactions, Increased Cellular Death.

What are the brand names for Isatuximab?

Isatuximab is marketed under brand names including Sarclisa.

What are the contraindications for Isatuximab?

Isatuximab labeling lists contraindications including: SARCLISA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients [see Warnings and Precautions (5.1) ] . Patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.. Always consult the full prescribing information and a clinician.