• Leukemias, lymphomas, and other hematologic cancers

Sarclisa Generic Name & Formulations

General Description

Isatuximab-irfc 100mg/5mL, 500mg/25mL; per vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

CD38-directed monoclonal antibody.

How Supplied

Single-dose vial—1


Generic Availability


Sarclisa Indications


In combination with pomalidomide and dexamethasone, for the treatment of multiple myeloma in adults who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor. In combination with carfilzomib and dexamethasone, for the treatment of relapsed or refractory multiple myeloma in adults who have received 1–3 prior lines of therapy.

Sarclisa Dosage and Administration


Premedicate with dexamethasone (oral or IV), acetaminophen (oral), H2 antagonists, diphenhydramine (oral or IV) 15–60mins prior to infusion; see full labeling. Give as an IV infusion. 10mg/kg on Days 1, 8, 15, and 22 for Cycle 1; then 10mg/kg on Days 1 and 15 for Cycle 2 and beyond. Each cycle consists of a 28-day period. Continue until disease progression or unacceptable toxicity. Infusion rates: see full labeling.


Not established.

Sarclisa Contraindications

Not Applicable

Sarclisa Boxed Warnings

Not Applicable

Sarclisa Warnings/Precautions


Should be administered by a healthcare professional with access to emergency equipment and medical support. Monitor for infusion-related reactions. Interrupt if Grade ≥2 infusion reactions occur; if symptoms improve to Grade ≤1, restart at half the initial infusion rate; monitor closely. Permanently discontinue if Grade 4 infusion-related reaction occurs or if symptoms do not improve to Grade ≤1 after interruption, persist or worsen despite treatment, or require hospitalization. Risk for neutropenia; monitor for infections. Monitor CBCs periodically during therapy; if Grade 4 neutropenia occurs, delay dose until neutrophil count recovery to ≥1.0×109/L; consider the use of antibiotics and antiviral prophylaxis during treatment. Monitor for second primary malignancies development. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.

Sarclisa Pharmacokinetics

See Literature

Sarclisa Interactions


May interfere with serological testing (eg, indirect antiglobulin [Coombs] test, antibody detection, antihuman globulin crossmatches), serum protein electrophoresis and immunofixation assays leading to false (+) results.

Sarclisa Adverse Reactions

Adverse Reactions

Upper respiratory tract infection, infusion-related reactions, pneumonia, diarrhea, fatigue, hypertension, dyspnea, insomnia, bronchitis, cough, back pain; lab abnormalities (decreased hemoglobin, decreased neutrophils, decreased lymphocytes, decreased platelets); neutropenia, second primary malignancies.

Sarclisa Clinical Trials

See Literature

Sarclisa Note

Not Applicable

Sarclisa Patient Counseling

See Literature