SARCLISA® (isatuximab) – Abbreviated Prescribing Information
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.
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) oral or intravenous, 20 mg for patients ≥75 years of age, Acetaminophen, Diphenhydramine. 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 (isatuximab regimen). Dosing schedule: 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.
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. 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 have been reported as laboratory abnormalities. 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) can 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 second 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). There is currently no available information with regards to how long the interference may persist. Based on the half-life of isatuximab, it may persist for approximately 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 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 serum, 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 ICARIA: 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, febrile neutropenia. Metabolism and nutrition disorders: 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 IKEMA: 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 other than skin cancers. Blood/lymphatic system disorders: common: neutropenia. 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.
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: February 2025.
Abbreviated Prescribing Information based on the EU SmPC as of March 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
Sweden
<strong>SARCLISA®</strong> (isatuximab) 20 mg/ml koncentrat till infusionsvätska, lösning. Rx, EF ATC-kod: L01XC38. <strong>Indikation:</strong> Sarclisa är indicerat i kombination med pomalidomid och dexametason, för behandling av vuxna patienter med recidiverande och refraktärt multipelt myelom, som tidigare har genomgått minst två behandlingar, där tidigare behandling inkluderat lenalidomid och en proteasomhämmare och med uppvisad sjukdomsprogression vid senaste behandlingen, och i kombination med karfilzomib och dexametason, för behandling av vuxna patienter med multipelt myelom som genomgått minst en tidigare behandling. <strong>Dosering:</strong> Rekommenderad dosering av Sarclisa är 10 mg/kg kroppsvikt i kombination med pomalidomid och dexametason eller i kombination med karfilzomib och dexametason. <strong>Kontraindikation:</strong> Överkänslighet mot den aktiva substansen eller mot något hjälpämne. <strong>Varningar och försiktighet:</strong> För att minska infusionsrelaterade reaktioner ska patienten premedicineras före Sarclisa-infusion. Tät uppföljning av vitala tecken ska göras under hela infusionen. Neutropeni och ökad infektionskänslighet kan förekomma. För fullständig information om dosering, kontraindikationer, varningar och försiktighet, biverkningar och pris, se <a href="https://www.fass.se" target="_blank">www.fass.se</a> <strong>Kontaktuppgifter:</strong> Sarclisa tillhandahålls av Sanofi AB, Box 300 52, 10425 Stockholm, tel +46 8 634 50 00. Vid frågor om våra läkemedel kontakta: <a href="mailto:infoavd@sanofi.com">infoavd@sanofi.com</a>. Datum för senaste översyn av produktresumén: 12/2021<br>▼ Detta läkemedel är föremål för utökad övervakning.<br><br>MAT-SE-2100513 (v1.0) april 2021.