Sarclisa

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Sarclisa Generic Name & Formulations

    Legal Class

    Rx

    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

    Manufacturer

    Sanofi U.S.

    Generic Availability

    NO

    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). In addition, isatuximab-irfc inhibits the ADP-ribosyl cyclase activity of CD38, activates natural killer (NK) cells in the absence of CD38-positive target tumor cells, and suppresses CD38-positive T-regulatory cells.

    Sarclisa Indications

    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

    Adult

    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.

    Children

    Not established.

    Sarclisa Contraindications

    Not Applicable

    Sarclisa Boxed Warnings

    Not Applicable

    Sarclisa Warnings/Precautions

    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 antibacterial 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

    Absorption

    Median time to reach steady state: 18 weeks with a 3.1-fold accumulation.

    Distribution

    Volume of distribution: 8.13 L.

    Metabolism

    Catabolic pathways.

    Elimination

    Total clearance of isatuximab-irfc decreased with increasing dose and with multiple doses. At steady-state, the near elimination (≥99%) of istaxuimab-irfc from plasma after the last dose is predicted to occur in ~2 months.

    Sarclisa Interactions

    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.

    Sarclisa Clinical Trials

    See Literature

    Sarclisa Note

    Not Applicable

    Sarclisa Patient Counseling

    See Literature

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