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FAQs
Frequently asked questions about SARCLISA
SARCLISA is indicated, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.1
Patients in the phase 3 IKEMA trial included those with baseline characteristics associated with a poor prognosis.2-4 These baseline characteristics were inclusive of patients with renal impairment, those who were refractory to lenalidomide, and those 75 years and older.2
For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design.
SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.1
Patients in the phase 3 ICARIA-MM trial included those with baseline characteristics associated with a poor prognosis.3-5 These baseline characteristics were inclusive of patients with renal impairment, who were refractory to lenalidomide, and those 75 years and older. The trial was also inclusive of patients who could have potential additional comorbidities, including COPD or asthma.5
For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design.
In the phase 3 IKEMA trial, SARCLISA demonstrated superior PFS when added to Kd. SARCLISA + Kd demonstrated superior median PFS of 3 years (35.7 months with SARCLISA + Kd vs 19.2 months with Kd alone; P=0.0021).1
For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design.
In the phase 3 ICARIA-MM trial, SARCLISA + Pd significantly extended median PFS to nearly 1 year (11.53 months with SARCLISA + Pd vs 6.47 months with Pd alone; P=0.001). A consistent benefit across subgroups and an improvement in ORR (60.4% with SARCLISA + Pd vs 35.3% with Pd alone; P<0.0001) were also shown in this population.1
For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design.
SARCLISA + Kd was evaluated in over 300 patients with relapsed and/or refractory multiple myeloma in a multicentre, multinational, randomised, open-label, 2-arm study. Patients had received 1 to 3 prior lines of therapy and were excluded if they were refractory to prior anti-CD38 therapy or received prior treatment with carfilzomib. Patients received either SARCLISA 10 mg/kg administered as an IV infusion in combination with Kd (n=179) or Kd alone (n=123), administered in 28-day cycles until disease progression or unacceptable toxicity.1
For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design.
SARCLISA is the first anti-CD38 antibody to report results in a phase 3 trial in combination with Pd vs Pd alone. Over 300 patients with relapsed and/or refractory multiple myeloma were included in the multicentre, multinational, randomised, open-label, 2-arm study. Patients had received at least 2 prior lines of therapy, including lenalidomide and a PI. Patients received either SARCLISA 10 mg/kg administered as an IV infusion in combination with Pd (n=154) or Pd alone (n=153), administered in 28-day cycles until disease progression or unacceptable toxicity.1,5
For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design.
Patients in both the IKEMA and ICARIA-MM trials included those with renal impairment, who were refractory to lenalidomide, and those 75 years and older. The ICARIA-MM trial was also inclusive of patients who could have potential additional comorbidities, including COPD or asthma.2,5
For more information about the phase 3 IKEMA and ICARIA-MM studies, view SARCLISA + Kd Trial Design and SARCLISA + Pd Trial Design.
The recommended dose of SARCLISA is 10 mg/kg body weight administered as an IV infusion in combination with Pd or Kd. Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity. Weekly dosing transitions to every other week after the first cycle until disease progression or unacceptable toxicity.1
For more information, view SARCLISA Administration.
SARCLISA is a 250-mL fixed volume infusion. Based on the infusion rates and incremental escalations, the first infusion lasts 3 hours and 20 minutes, followed by 1 hour and 53 minutes for the second infusion, and 75 minutes for the third infusion onward. Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions.1
For more information, view Dosing Schedule.
In IKEMA, the most frequent adverse reactions (≥20%) were infusion reactions (46%), hypertension (37%), diarrhoea (36%), upper respiratory tract infection (36%), pneumonia (29%), fatigue (28%), dyspnoea (28%), insomnia (24%), bronchitis (23%), and back pain (22%).2
For more information, view SARCLISA + Kd Adverse Reactions.
In ICARIA-MM, the most frequent adverse reactions (≥20%) were neutropenia (47%), infusion reactions (38%), pneumonia (31%), upper respiratory tract infection (28%), diarrhoea (26%), and bronchitis (24%).1
For more information, view SARCLISA + Pd Adverse Reactions.
Quality of life, as assessed by the Global Health Status Score, was maintained during treatment. These results indicated that when the IV infusion of SARCLISA was added as a third drug to the 2-drug regimen of Pd or Kd, quality of life was maintained on the 3-drug regimens of both SARCLISA + Kd and SARCLISA + Pd as compared to the 2-drug regimen.2,5-7
For more information, view SARCLISA + Kd Quality of Life and SARCLISA + Pd Quality of Life.
SARCLISA is an anti-CD38 mAb that targets a specific epitope, resulting in multimodal effects. In vitro, SARCLISA directly destroys myeloma cells without requiring immune cells.1,8
For more information, view Mechanism of Action.
References: 1. SARCLISA [summary of product characteristics]. sanofi-aventis groupe: Paris, France; 2025. 2. Moreau P, Dimopoulos MA, Mikhael J, et al; IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021;397(10292):2361-2371. doi:10.1016/S0140-6736(21)00592-4 3. Hájek R, Jarkovsky J, Maisnar V, et al. Real-world outcomes of multiple myeloma: retrospective analysis of the Czech Registry of Monoclonal Gammopathies. Clin Lymphoma Myeloma Leuk. 2018;18(6):e219-e240. 4. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter International Myeloma Working Group study. Leukemia. 2012;26(1):149-157. 5. Attal M, Richardson PG, Rajkumar SV, et al; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-2107. 6. Supplement to: Moreau P, Dimopoulos MA, Mikhael J, et al; IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021;397(10292):2361-2371. doi:10.1016/S0140-6736(21)00592-4 7. Supplement to: Attal M, Richardson PG, Rajkumar SV, et al; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214)(suppl):2096-2107. 8. Feng X, Zhang L, Acharya C, et al. Targeting CD38 suppresses induction and function of T regulatory cells to mitigate immunosuppression in multiple myeloma. Clin Cancer Res. 2017;23(15):4290-4300.
Sanofi does not recommend the use of its products in any manner inconsistent with that described in the label available in your country. Please refer to your local product labelling information before prescribing.
View your country-specific product labelling information here.
Name and Presentation: SARCLISA 20 mg/mL concentrate for solution for infusion. Each vial contains 100 mg of isatuximab in 5 mL of concentrate (100 mg/5 mL) or 500 mg of isatuximab in 25 mL of concentrate (500 mg/25 mL). Isatuximab is an immunoglobulin G1 (IgG1) monoclonal antibody (mAb).
Therapeutic indications: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Pediatric population: Outside its authorised indications, SARCLISA has been studied in children aged 28 days to less than 18 years of age with relapsed or refractory acute lymphoblastic or myeloid leukaemia but efficacy has not been established.
Dosage and administration: SARCLISA should be administered by a healthcare professional, in an environment where resuscitation facilities are available. Premedication should be used 15-60 minutes prior to SARCLISA infusion with the following medicinal products to reduce the risk and severity of infusion reactions: Dexamethasone 40 mg (when administered in combination with isatuximab and pomalidomide) or 20 mg (when administered in combination with isatuximab and carfilzomib; or when administered in combination with isatuximab, bortezomib, and lenalidomide) oral or intravenous, 20 mg for patients ≥75 years of age, Acetaminophen, Diphenhydramine, H2 antagonists. The recommended dose of SARCLISA is 10 mg/kg body weight administered as an intravenous infusion in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone or in combination with bortezomib, lenalidomide, and dexamethasone (isatuximab regimen). Dosing schedule in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone: cycle 1: days 1, 8, 15 and 22 (weekly), cycle 2 and beyond: days 1, 15 (every 2 weeks). Each treatment cycle consists of a 28-day period. Dosing schedule in combination with bortezomib, lenalidomide, and dexamethasone: cycle 1: days 1, 8, 15, 22 and 29, cycles 2 to 4: days 1, 15 and 29 (every 2 weeks), cycles 5 to 17: days 1 and 15 (every 2 weeks), cycles 18 and beyond: day 1 (every 4 weeks). Each treatment cycle consists of a 42-day period from cycle 1 to 4, and of a 28-day period from cycle 5. Treatment is repeated until disease progression or unacceptable toxicity.
Method of administration: SARCLISA is for intravenous use. For details on preparation and infusion rate see full SmPC.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. See full SmPC for full list of excipients.
Warnings and precautions: Infusion reactions, mostly mild or moderate, were observed in 38.2% of patients treated with SARCLISA in ICARIA, and in 45.8% in IKEMA but resolved on the same day in 98% of infusions, and in 24.0% of patients treated with Isa-VRd in IMROZ and resolved the same day in 97.3% of patients. The most common symptoms of an IR included dyspnoea and chills. The most common severe sign and symptom was hypertension. Vital signs should be frequently monitored during the entire infusion and when required infusion should be interrupted or permanently discontinued in case symptoms that do not improve to grade ≤1 after infusion interruption. Serious infusion reactions including severe anaphylactic reactions have also been observed after SARCLISA administration. Most of the grade 3-4 neutropenia was reported as laboratory abnormalities. In patients treated with Isa-VRd, neutropenia was reported as a laboratory abnormality in 87.5% of patients and as an adverse reaction in 30% of patients. Neutropenic complications have been observed in 1/3 of patients treated with SARCLISA. A higher incidence of infections including grade ≥3 infections occurred with SARCLISA. Antibacterial and antiviral prophylaxis (such as herpes zoster prophylaxis) according to treatment guidelines should be considered during treatment. Patients receiving SARCLISA should be closely monitored for signs of infection. Physicians should carefully evaluate patients before and during treatment as per International Myeloma Working Group (IMWG) guidelines for occurrence of secondary primary malignancies (SPM) and treatment should be initiated as indicated. Patients should be monitored closely, and appropriate precautions taken for tumor lysis syndrome. Isatuximab 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 at least 6 months after the last infusion of SARCLISA. Patient should have blood type and screen tests performed prior to the first infusion of Isatuximab and should be monitored for theoretical risk of haemolysis. For details in tests interference see full SmPC.
Drug interactions: Isatuximab has no impact on the pharmacokinetics of pomalidomide or carfilzomib, or bortezomib, or lenalidomide and vice versa. Isatuximab may interfere with serological testing and with Serum Protein Electrophoresis and Immunofixation assays. In patients with persistent very good partial response, where isatuximab interference is suspected, consider using a validated isatuximab-specific IFE assay to distinguish isatuximab from any remaining endogenous M protein in the patient’s, to facilitate determination of complete response.
Fertility, pregnancy and lactation: Women of childbearing potential treated with isatuximab should use effective contraception during treatment and for 5 months after cessation of treatment. The use of isatuximab in pregnant women is not recommended since there are no available data.
Undesirable effects: Observed in patients treated with isatuximab in combination with pomalidomide and dexamethasone: Infections/infestations: very common: pneumonia, upper respiratory tract infection, bronchitis: common: Herpes zoster. Neoplasms benign, malignant and unspecified: common: skin cancer, solid tumour (non-skin cancer): uncommon: haematology malignancy. Blood/lymphatic system disorders: very common: neutropenia, thrombocytopenia, common: febrile neutropenia, anaemia, unknown frequency: lymphopenia. Metabolism and nutrition disorders: very common: decreased appetite. Cardiac disorders: common: atrial fibrillation. Respiratory, thoracic and mediastinal disorders: very common: dyspnoea. Gastrointestinal disorders: very common: diarrhoea, nausea, vomiting. Investigations: common: weight decreased. Injury, poisoning and procedural complications: very common: infusion reaction. Immune system disorders: uncommon: anaphylactic reaction. Observed in patients treated with isatuximab in combination with carfilzomib and dexamethasone: Infections/infestations: very common: pneumonia, upper respiratory tract infection, bronchitis: common: Herpes Zoster. Vascular disorder: very common: hypertension. Neoplasms benign, malignant and unspecified: common: Skin cancers and solid tumors non-skin cancers. Blood/lymphatic system disorders: common: neutropenia, anaemia, thrombocytopenia, unknown frequency: lymphopenia. Respiratory, thoracic and mediastinal disorders: very common: dyspnoea and cough. Gastrointestinal disorders: very common: diarrhoea and vomiting. General disorders and administration site conditions: very common: Fatigue. Injury, poisoning and procedural complications: very common: infusion reaction. Immune system disorders: uncommon: anaphylactic reaction. Reported in patients with multiple myeloma treated with isatuximab in combination with bortezomib, lenalidomide, and dexamethasone: Infections/infestations: very common: pneumonia, bronchitis, Covid-19. Neoplasms benign, malignant and unspecified: common: skin cancer, solid tumour, uncommon: haematology malignancy. Blood and lymphatic system disorders: very common: neutropenia, thrombocytopenia, common: anaemia, not known: lymphopenia. Immune system disorders: uncommon: anaphylactic reaction. Eye disorders: very common: cataract. Gastrointestinal disorders: very common: diarrhoea, common: vomiting. General disorders and administration site conditions: very common: fatigue. Injury, poisoning and procedural complications: very common: infusion reaction.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01FC02.
List of excipients: Sucrose, Histidine hydrochloride monohydrate, Histidine, Polysorbate 80 and Water for injections.
Legal classification: Prescription Only Medicine.
Marketing authorization holder: Sanofi Winthrop Industrie, 82, avenue Raspail, 94250 Gentilly, France.
Date of last revised: March 2025.
Abbreviated Prescribing Information based on the EU SmPC as of February 2025.
Before prescribing always refer to your full local prescribing information as this information may vary from country to country
MAT-GLB-2101917-v10.0-03/2025