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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
Generic Availability
NO
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 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
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
