For more information, ask your healthcare provider or pharmacist. To decrease the risk and severity of infusion-related reactions, premedicate patients prior to SARCLISA infusion with acetaminophen, H2 antagonists, diphenhydramine, or equivalent; dexamethasone [see Dosage and Administration (2.2)]. Fertility studies have not been conducted with isatuximab-irfc. Administer the following premedications prior to Sarclisa infusion to reduce the risk and severity of infusion-related reactions [see Warnings and Precautions (5.1)]: The above recommended dose of dexamethasone (orally or intravenously) corresponds to the total dose to be administered only once before infusion as part of the premedication and of the backbone treatment, before Sarclisa and pomalidomide administration. Up to 2 times the approved recommended dose, SARCLISA does not prolong the QT interval to any clinically relevant extent. The most common symptoms of an infusion-related reaction included dyspnea, cough, chills, and nausea. The most frequent adverse reactions requiring permanent discontinuation in patients who received Isa-Pd were infections (2.6%). “part 341”). (, Neutropenia: Monitor complete blood cell counts periodically during treatment. Refer to the pomalidomide prescribing information on use during pregnancy. Treatment is repeated until disease progression or unacceptable toxicity. Withdraw the necessary volume of SARCLISA injection and dilute by adding to the infusion bag of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to achieve the appropriate SARCLISA concentration for infusion. Isatuximab-irfc is expected to be metabolized into small peptides by catabolic pathways. The mean (CV %) predicted total volume of distribution of isatuximab-irfc is of 8.13 L (26.2%). when you use our Services. The median patient age was 67 years (range 36–86), 20% of patients were ≥75 years; 10% of patients entered the study with a history of COPD or asthma. In addition, Sarclisa alone was discontinued in 3% of patients due to infusion-related reactions. The most frequent neutropenic infections included those of upper respiratory tract (10%), lower respiratory tract (9%), and urinary tract (3%) [see Adverse Reactions (6.1)]. The labels are also available on the National Library of Medicine's DailyMed web site. Following the administration of isatuximab-irfc at the recommended dose and schedule, the steady state isatuximab-irfc mean (CV %) predicted maximum plasma concentration (Cmax) was 351 µg/mL (36.0%) and area under the plasma concentration-time curve (AUC) was 72,600 µg∙h/mL (51.7%). The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. Each treatment cycle consists of a 28-day period. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. Patients received Sarclisa 10 mg/kg intravenously, weekly in the first cycle and every two weeks thereafter, in combination with pomalidomide and low dose dexamethasone (Isa-Pd) (n=152) or pomalidomide and low dose dexamethasone (Pd) (n=149) [see Clinical Studies (14)]. Administer the infusion solution by intravenous infusion using an intravenous tubing infusion set (in PE, PVC with or without DEHP, polybutadiene [PBD], or polyurethane [PU]) with a 0.22 micron in-line filter (polyethersulfone [PES], polysulfone, or nylon). Acetaminophen 650 mg to 1000 mg orally (or equivalent). Therefore, the neutralizing ADA status was not determined. Signs and symptoms of Grade 3 or higher infusion-related reactions included dyspnea, hypertension, and bronchospasm. Serious adverse reactions in >5% of patients who received Isa-Pd included pneumonia (26%), upper respiratory tract infections (7%), and febrile neutropenia (7%). Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. Second primary malignancies were reported in 3.9% of patients in the SARCLISA, pomalidomide and dexamethasone (Isa-Pd) arm and in 0.7% of patients in the pomalidomide and dexamethasone (Pd) arm, and consisted of skin squamous cell carcinoma (2.6% of patients in the Isa-Pd arm and in 0.7% of patients in the Pd arm), breast angiosarcoma (0.7% of patients in the Isa-Pd arm) and myelodysplastic syndrome (0.7% of patients in the Isa-Pd arm). Do not administer Sarclisa infusion solution concomitantly in the same intravenous line with other agents. Treatment was administered in both groups in 28-day cycles until disease progression or unacceptable toxicity. The incidence of infusion interruptions because of infusion-related reactions was 29.6%. Sarclisa may cause fetal immune cell depletion and decreased bone density. Dosage Form: injection, solution, concentrate. The combination of isatuximab-irfc and pomalidomide enhanced ADCC activity and direct tumor cell killing compared to that of isatuximab-irfc alone in vitro, and enhanced antitumor activity compared to the activity of isatuximab-irfc or pomalidomide alone in a human multiple myeloma xenograft model. The median duration of response was 13.3 months (95% CI: 10.6-NR) in the Isa-Pd group versus 11.1 months (95% CI: 8.5-NR) in the Pd group. By using our Services, you agree that www.HIPAASpace.com can use such data Interference with Serological Testing (Indirect Antiglobulin Test). View Label Archives, The incidence of infusion interruptions because of infusion-related reactions was 29.6%. (, The recommended dose of SARCLISA is 10 mg/kg as an intravenous infusion every week for 4 weeks followed by every 2 weeks in combination with pomalidomide and dexamethasone until disease progression or unacceptable toxicity. All infusion-related reactions started during the first SARCLISA infusion and resolved on the same day in 98% of the cases. Pomalidomide 4 mg was taken orally once daily from day 1 to day 21 of each 28-day cycle. Each mL of solution contains 20 mg isatuximab-irfc, histidine (1.46 mg), histidine hydrochloride monohydrate (2.22 mg), polysorbate 80 (0.2 mg), sucrose (100 mg), and water for injection. A SANOFI COMPANY Isatuximab-irfc induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). The median time to reach steady state of isatuximab-irfc was 8 weeks with a 3.1-fold accumulation. At a median follow-up time of 11.6 months, 43 (27.9%) patients on Isa-Pd and 56 (36.6%) patients on Pd had died. Sample Dexamethasone 40 mg orally or intravenously (or 20 mg orally or intravenously for patients ≥75 years of age). Refer to pomalidomide prescribing information for additional information. SARCLISA is used in combination with pomalidomide and dexamethasone. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Febrile neutropenia occurred in 12% of patients and neutropenic infections, defined as infection with concurrent grade ≥3 neutropenia, occurred in 25% of patients treated with Isa-Pd. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa. In multiple myeloma patients treated with SARCLISA combined with pomalidomide and dexamethasone, a decrease in absolute counts of total NK cells (including inflammatory CD16+ low CD56+ bright and cytotoxic CD16+ bright CD56+ dim NK cells) and CD19+ B cells was observed in peripheral blood. NDC Number Search: Active Ingredient Search: Application Number or Regulatory Citation Search: Company Search: Proprietary Name and Company Search: Search for Labels on DailyMed. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. The recommended dose of SARCLISA is 10 mg/kg actual body weight administered as an intravenous infusion in combination with pomalidomide and dexamethasone, according to the schedule in Table 1 [see Clinical Studies (14)]. If symptoms improve, restart SARCLISA infusion at half of the initial infusion rate, with supportive care as needed, and closely monitor patients. Select one or more newsletters to continue. Isatuximab-irfc induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). The efficacy and safety of SARCLISA in combination with pomalidomide and low-dose dexamethasone (Isa-Pd) were evaluated in ICARIA-MM (NCT02990338), a multicenter, multinational, randomized, open-label, 2-arm, phase 3 study in patients with relapsed and refractory multiple myeloma. Multilevel packages will have the descriptions concatenated together. Dose delay may be required to allow recovery of blood counts in the event of hematological toxicity [see Warnings and Precautions (5.2, 5.4)]. In case symptoms do not improve or recur after interruption, permanently discontinue SARCLISA and institute appropriate management. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Injection: 100 mg/5 mL (20 mg/mL) in a single-dose vial, Injection: 500 mg/25 mL (20 mg/mL) in a single-dose vial, One 100 mg/5 mL single-dose vial in a carton: NDC 0024-0654-01, One 500 mg/25 mL single-dose vial in a carton: NDC 0024-0656-01. are pregnant or plan to become pregnant. In the event of overdose of Sarclisa, monitor the patients for signs or symptoms of adverse effects and take all appropriate measures immediately. (, Second Primary Malignancies (SPM): Monitor patients for the development of second primary malignancies, as per IMWG guidelines. in accordance with our privacy policies. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Copy the URL below and paste it into your RSS Reader application. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. Each mL of solution contains 20 mg isatuximab-irfc, histidine (1.46 mg), histidine hydrochloride monohydrate (2.22 mg), polysorbate 80 (0.2 mg), sucrose (100 mg), and water for injection. The improvement in PFS represented a 40% reduction in the risk of disease progression or death in patients treated with Isa-Pd. The translation of the DosageForm Code submitted by the firm. Safety and effectiveness in pediatric patients have not been established. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Second primary malignancies were reported in 3.9% of patients in the Sarclisa, pomalidomide and dexamethasone (Isa-Pd) arm and in 0.7% of patients in the pomalidomide and dexamethasone (Pd) arm, and consisted of skin squamous cell carcinoma (2.6% of patients in the Isa-Pd arm and in 0.7% of patients in the Pd arm), breast angiosarcoma (0.7% of patients in the Isa-Pd arm) and myelodysplastic syndrome (0.7% of patients in the Isa-Pd arm). In ICARIA-MM, the incidence of Grade 3 or higher infections was 43% in Isa-Pd group. 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. Overall, across 6 clinical studies in multiple myeloma (MM) with SARCLISA single agent and combination therapies including ICARIA-MM (N=564), the incidence of treatment emergent ADAs was 2.3%. Carcinogenicity and genotoxicity studies have not been conducted with isatuximab-irfc. Advise pregnant women of the potential risk to a fetus. Do not shake. At steady state, the near elimination (≥99%) of isatuximab-irfc from plasma after the last dose is predicted to occur in approximately 2 months.

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