Isatuximab

What it is and how it works

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. 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). Isatuximab-irfc inhibits the ADP-ribosyl cyclase activity of CD38. Isatuximab-irfc can activate natural killer (NK) cells in the absence of CD38-positive target tumor cells and suppresses CD38-positive T-regulatory cells.

Mechanism class: CD38-directed Antibody Interactions

Indications

is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy 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. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). SARCLISA ESCENA is a CD38-directed cytolytic antibody indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy 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.

Dosage and administration (summary)

and intravenous isatuximab-irfc have different dosage and route of administration instructions. Administer SARCLISA ESCENA only as a subcutaneous injection. Premedicate with dexamethasone, leukotriene receptor antagonist, acetaminophen, and diphenhydramine. The recommended dosage of SARCLISA ESCENA is 1,400 mg administered as subcutaneous injection with the CirCLIQ™ On-Body Delivery System (OBDS) or with a syringe and infusion set for manual administration. See full prescribing information for SARCLISA ESCENA schedules of administration and drugs used in combination.

Contraindications

is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients . Patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.

Warnings and precautions

Hypersensitivity and Other Administration Reactions: In case of grade ≥2 systemic administration reaction (SAR), interrupt SARCLISA ESCENA and manage medically. In case of grade 4 SAR, permanently discontinue SARCLISA ESCENA. Neutropenia : Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. SARCLISA ESCENA dose delays and the use of colony-stimulating factor may be required to allow improvement of neutrophil count. Infections : SARCLISA ESCENA may cause serious and fatal infections.

Pregnancy

Pregnancy Risk Summary Based on its mechanism of action , SARCLISA ESCENA can cause fetal harm when administered to a pregnant woman. There are no available data on SARCLISA ESCENA use in pregnant women to evaluate for a drug-associated risk.

Storage and supply

Storage Store SARCLISA ESCENA vial in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until 20 minutes prior to use. Do not freeze. Do not shake. Unpunctured vials may be stored at ambient temperature between 18°C to 28°C (64°F to 82°F) for a single period of up to 24 hours.

Source: Isatuximab-Irfc (Sarclisa Escena) — US FDA prescribing information, 2026-07-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.