Leukemias, lymphomas, and other hematologic cancers:

Indications for: SARCLISA

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.

Adult Dosage:

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 Dosage:

Not established.

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 Classification:

CD38-directed monoclonal antibody.

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.

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.

Generic Drug Availability:


How Supplied:

Single-dose vial—1