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Full Prescribing Information

Important Safety Information

For patients with NDMM not eligible for transplant

IMROZ REGIMEN: A BENCHMARK FOR mPFS vs VRd ALONE

Higher 5-year PFS rate with SARCLISA + VRd vs VRd alone: 63% of patients remained alive and progression free compared to 45% of patients receiving VRd alone at a median follow-up of 60 months^1-4

mPFS not reached with SARCLISA + VRd (n=265) vs 54 months with VRd alone (n=181) HR=0.60 (95% CI: 0.44, 0.81; P=0.0009)¹

Please see study design below the Important Safety Information.

Proven safety^1,2

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The most common adverse reactions (≥20%, all grades) in the SARCLISA + VRd arm (n=263) vs the VRd arm (n=181), respectively, were upper respiratory tract infections (65% vs 57%), diarrhea (55% vs 49%), fatigue (55% vs 50%), peripheral sensory neuropathy (54% vs 61%), pneumonia (45% vs 31%), musculoskeletal pain (38% vs 33%), cataract (38% vs 25%), constipation (36% vs 41%), peripheral edema (33% vs 33%), rash (32% vs 34%), infusion-related reaction (24% vs 1.1%), insomnia (22% vs 24%), and COVID-19 (22% vs 17%)

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The most common hematologic laboratory abnormalities (≥80%, all grades) in the SARCLISA + VRd arm vs the VRd arm, respectively, were decreased hemoglobin (99% vs 98%), decreased leukocytes (97% vs 88%), decreased lymphocytes (95% vs 92%), decreased platelets (95% vs 85%), and decreased neutrophils (87% vs 80%)

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Grade ≥3 peripheral neuropathy was 7% with SARCLISA + VRd vs 6% with VRd alone

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Discontinuations due to adverse events were similar across arms: 23% for SARCLISA + VRd, 26% for VRd

Please see additional Important Safety Information below.

Explore results from the IMROZ trial for the first and only FDA-approved anti-CD38 + VRd therapy in patients with NDMM not eligible for transplant^1,5

SEE THE DATA

Indication

SARCLISA (isatuximab-irfc) is indicated:

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In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)

Important Safety Information

CONTRAINDICATIONS

SARCLISA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

Serious infusion-related reactions (IRRs), including life-threatening anaphylactic reactions, have occurred with SARCLISA treatment. Severe signs and symptoms include cardiac arrest, hypertension, hypotension, bronchospasm, dyspnea, angioedema, and swelling.

In 3 clinical trials, in patients treated with SARCLISA (N=592), infusion-related reactions occurred in 206 patients (35%). Among these 206 patients, 92% experienced infusion-related reactions during the first infusion and 12% after the first cycle.

The most common symptoms (≥5%) of an infusion-related reaction included dyspnea and cough. Grade 1 infusion-related reactions were reported in 6% of patients, grade 2 in 28%, and grade 3 or 4 in 1.2%. Anaphylactic reactions occurred in less than 1% of patients. The total incidence of SARCLISA infusion interruptions was less than 1% and the incidence of patients with at least one SARCLISA infusion interruption due to infusion-related reactions was 26%. The median time to first SARCLISA infusion interruption was 61 minutes (range 4 to 240 minutes). SARCLISA was discontinued in 1% of patients due to infusion-related reactions. To decrease the risk and severity of IRRs, premedicate patients prior to SARCLISA infusion with acetaminophen, H₂ antagonists, diphenhydramine or equivalent, and dexamethasone.

Monitor vital signs frequently during the entire SARCLISA infusion. For patients with grade ≥2 reactions, interrupt SARCLISA infusion and provide appropriate medical management. For patients with grade 2 or grade 3 reactions, if symptoms improve to grade ≤1, restart SARCLISA infusion at half of the initial infusion rate, with supportive care as needed, and closely monitor patients. If symptoms do not recur after 30 minutes, the infusion rate may be increased to the initial rate, and then increased incrementally. In case symptoms do not improve to grade ≤1 after interruption of SARCLISA infusion, persist or worsen despite appropriate medications, or require hospitalization, permanently discontinue SARCLISA and institute appropriate management. Permanently discontinue SARCLISA if an anaphylactic reaction or life-threatening (grade 4) IRR occurs and institute appropriate management.

Infections

SARCLISA can cause severe, life-threatening, or fatal infections. In patients who received SARCLISA at the recommended dose in 3 clinical trials (N=592), serious infections, including opportunistic infections, occurred in 46%, grade 3 or 4 infections occurred in 43%, and fatal infections occurred in 4.7%. The most common serious infection reported was pneumonia (32%).

Monitor patients for signs and symptoms of infection prior to and during treatment with SARCLISA and treat appropriately. Administer prophylactic antimicrobials according to guidelines.

Neutropenia

SARCLISA may cause neutropenia.

In 3 clinical trials, in patients treated with SARCLISA (N=592), neutropenia based on laboratory values occurred in 81%, with grade 3 or 4 occurring in 52%. Neutropenic infections occurred in 12% of patients, with grade 3 or 4 in 4.9%, and febrile neutropenia in 4%.

Monitor complete blood cell counts periodically during treatment. If needed, use antibacterial and antiviral prophylaxis during treatment. Monitor patients with neutropenia for signs of infection. In case of grade 4 neutropenia, delay SARCLISA dose until neutrophil count recovery to at least 1 x 10⁹/L, and provide supportive care with growth factors, according to institutional guidelines. No dose reductions of SARCLISA are recommended.

Second Primary Malignancies

The incidence of second primary malignancies, during treatment and post-treatment, is increased in patients treated with SARCLISA-containing regimens. In 3 clinical trials, in patients treated with SARCLISA (N=592), second primary malignancies occurred in 71 patients (12%).

In IMROZ study, at a median follow-up time of 60 months, second primary malignancies occurred in 16% of patients treated with SARCLISA, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) and in 9% of patients treated with VRd.

The most common (≥1%) second primary malignancies in 3 clinical trials (N=592) included skin cancers (7% with SARCLISA-containing regimens and 3.1% with comparative regimens) and solid tumors other than skin cancer (4.6% with SARCLISA-containing regimens and 2.9% with comparative regimens). Patients with non-melanoma skin cancer continued treatment after resection of the skin cancer, except 2 patients in the Isa-VRd arm and 1 patient in the VRd arm of the IMROZ study. Monitor patients for the development of second primary malignancies.

Laboratory Test Interference

Interference with Serological Testing (Indirect Antiglobulin Test)

SARCLISA binds to CD38 on red blood cells (RBCs) and may result in a false-positive indirect antiglobulin test (indirect Coombs test). This interference with the indirect Coombs test may persist for approximately 6 months after the last infusion of SARCLISA. In patients with a positive indirect antiglobulin test, blood transfusions were administered without evidence of hemolysis. ABO/RhD typing was not affected by SARCLISA treatment.

Before the first SARCLISA infusion, conduct blood type and screen tests on SARCLISA-treated patients. Consider phenotyping prior to starting SARCLISA treatment. If treatment with SARCLISA has already started, inform the blood bank that the patient is receiving SARCLISA and that 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.

Interference with Serum Protein Electrophoresis and Immunofixation Tests

SARCLISA is an IgG kappa monoclonal antibody that can be incidentally detected on both serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the accuracy of the determination of complete response in some patients with IgG kappa myeloma protein.

Embryo-Fetal Toxicity

Based on the mechanism of action, SARCLISA can cause fetal harm when administered to a pregnant woman. SARCLISA may cause fetal immune cell depletion and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use an effective method of contraception during treatment with SARCLISA and for 5 months after the last dose. The combination of SARCLISA with lenalidomide is contraindicated in pregnant women because lenalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) in patients receiving Isa-VRd were upper respiratory tract infections, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19. The most common hematologic laboratory abnormalities (≥80%) in patients receiving Isa-VRd were decreased hemoglobin, decreased leukocytes, decreased lymphocytes, decreased platelets, and decreased neutrophils.

Serious adverse reactions occurred in 71% of patients receiving Isa-VRd. The serious adverse reaction in >5% of patients who received Isa-VRd was pneumonia (30%). Fatal adverse reactions occurred in 11% of patients with Isa-VRd (those occurring in more than 1% of patients were pneumonia [5%]).

USE IN SPECIAL POPULATIONS

Because of the potential for serious adverse reactions in the breastfed child from isatuximab-irfc administered in combination with lenalidomide and dexamethasone, advise lactating women not to breastfeed during treatment with SARCLISA.

Please see full Prescribing Information.

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https://www.sanofi.us/en/products-and-resources.

IMROZ study design: IMROZ was a multicenter, multinational, randomized, open-label, 2-arm, phase 3 study that evaluated the efficacy and safety of SARCLISA in 446 patients with NDMM who were not eligible for transplant. IMROZ was conducted in 2 phases: an induction phase and a continuous phase. Patients received either SARCLISA 10 mg/kg administered as an IV infusion in combination with VRd (n=265) or VRd alone (n=181) in four 42-day cycles. Following the induction phase, bortezomib was discontinued for both treatment arms. SARCLISA was given weekly in the first cycle and every 2 weeks during cycles 2 to 17, and monthly for cycle 18+. PFS was the primary endpoint. ≥CR, MRD- in ≥CR, ≥VGPR, and OS were key secondary endpoints.¹

CR=complete response; FDA=Food and Drug Administration; IV=intravenous; mPFS=median progression-free survival; MRD-=minimal (or measurable) residual disease negativity; NDMM=newly diagnosed multiple myeloma; OS=overall survival; PFS=progression-free survival; VGPR=very good partial response; VRd=bortezomib, lenalidomide, dexamethasone.

References: 1. SARCLISA. Prescribing information. sanofi-aventis U.S. LLC; 2024. 2. Facon T, Dimopoulos MA, Leleu XP, et al; IMROZ Study Group. Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. Published online June 3, 2024. doi:10.1056/ NEJMoa2400712 3. Kumar SK, Jacobus SJ, Cohen AD, et al. Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for newly diagnosed multiple myeloma without intent for immediate autologous stem-cell transplant (E1A11): a multicenter, open-label, phase 3, randomized, controlled trial. Lancet Oncol. 2020;21(10):1317-1330. 4. Durie BGM, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet. 2017;389(10068):519-527. 5. Darzalex. Prescribing information. Janssen Pharmaceutical Companies; 2024.

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MAT-US-2411403-v2.0-2/2025

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