SARCLISA® (isatuximab-irfc)
Sarclisa is a monoclonal antibody, a targeted anti-myeloma therapy that kills myeloma cells directly and also recruits surrounding immune system cells to enhance the myelomakilling process. The U.S. Food and Drug Administration (FDA) first approved Sarclisa for use in myeloma in 2020.
FDA-approved indications for Sarclisa
As of November 2024, the following are the FDA-approved combination therapies for myeloma that include Sarclisa:
¡ Sarclisa + Velcade® (bortezomib) + Revlimid® (lenalidomide) + dexamethasone [Isa-VRd] for patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for an autologous stem cell transplant (ASCT).
¡ Sarclisa + Kyprolis® (carfilzomib) + dexamethasone [Isa-Kd] for patients with relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior lines of therapy.
¡ Sarclisa + Pomalyst® (pomalidomide) + dexamethasone [Isa-Pd] for patients with RRMM who have received at least 2 prior therapies including Revlimid and a proteasome inhibitor, such as Velcade, Kyprolis, or Ninlaro® (ixazomib).
Warnings and precautions
¡ Infusion-Related Reaction (IRR): Serious IRRs, including life-threatening anaphylactic reactions, have occurred with Sarclisa treatment in less than 1% of patients who participated in the ICARIA-MM, IKEMA, and IMROZ clinical trials. Signs and symptoms include cardiac arrest, hypertension, hypotension, bronchospasm, dyspnea, angioedema, and swelling. In clinical trials with Sarclisa, IRRs were related to treatment discontinuation in 1% of patients. Your doctor will prescribe medication to decrease the risk and severity of IRRs.
¡ Infection: Sarclisa can cause severe, life-threatening, or fatal infections. In the above-cited clinical trials, serious infections occurred in 46% of study patients who received Sarclisa at the recommended dose, Grade 3 or 4 infections occurred in 43%, and fatal infections occurred in 4.7%. The most common serious infection reported was pneumonia, which occurred in 32% of study patients. Your doctor will prescribe medication to decrease the risk and severity of infections.
¡ Neutropenia: A reduced level of neutrophils (a type of white blood cell) can lead to infection caused by bacteria or fungi. Neutropenia occurred in 81% of patients who received Sarclisa in the above-cited clinical trials, with Grade 3 or 4 in 52% of study patients. Fever is the most common sign of neutropenia. If you develop a fever, you must get immediate medical attention.
¡ Second primary malignancy (SPM): In the above-cited clinical trials, the incidence of SPMs was increased in patients treated with Sarclisa, occurring in 12% of study patients. The most common SPMs that occurred in 1% or more of study patients included skin cancers and solid tumors (other than skin cancers).
¡ Laboratory test interference:
Sarclisa may interfere with serological testing and may result in a false-positive indirect antiglobulin test. Patients are tested for blood type before their first infusion of Sarclisa. Interference with blood compatibility testing can be resolved using dithiothreitol-treated RBCs. If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices.
Sarclisa may interfere with serum protein electrophoresis (SPEP) and immunofixation (IFE) tests used to monitor M-protein. This can impact the accuracy of the determination of complete response (CR) in some patients with IgG kappa myeloma protein.
¡ Embryo-fetal toxicity: Sarclisa can cause fetal harm. Female patients of reproductive potential must use an effective method of contraception during treatment with Sarclisa and for 5 months after the last dose of Sarclisa. (Due to the potential for harm in the breastfed child, lactating women should not breastfeed during treatment with Sarclisa.)
Access and support resources
To explore the access and support resources for Sarclisa that may be available for eligible patients, please visit sarclisa.com/paying-for-sarclisa to enroll in CareASSIST
Patient Support by Sanofi. You will be paired with a Case Manager trained to assist you across a spectrum of nonclinical support and personalized guidance.