SARCLISA® (isatuximab for injection) is indicated:
- in combination with pomalidomide and dexamethasone, for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
- in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
Important Safety Information
Clinical use:
SARCLISA® is not indicated in pediatric patients (<18 years of age). No overall differences in safety and efficacy were observed between older (≥65 years of age) and younger patients.
Contraindications:
- Hypersensitivity to SARCLISA® or any ingredient in the formulation or any of its components.
Most serious warnings and precautions:
- Neutropenia: Neutropenia occurred as a laboratory abnormality in 54.8% of patients treated with SARCLISA® in combination with carfilzomib and dexamethasone, with Grade 3–4 neutropenia reported as a laboratory abnormality in 19.2% of patients (Grade 3 in 17.5%, Grade 4 in 1.7%). Neutropenic complications occurred in 2.8% of patients, including febrile neutropenia (1.1%) and neutropenic infections (1.7%). Grade 3 and 4 neutropenia occurred as laboratory abnormalities in 24.3% and 60.5% of patients treated with SARCLISA® in combination with pomalidomide and dexamethasone. Neutropenic complications included febrile neutropenia (11.8% of patients) and neutropenic infections (25% of patients). Monitor complete blood cell counts at baseline and periodically during treatment. Monitor patients with neutropenia for signs of infection.
- Infusion-related reactions (IRRs): IRRs, mostly Grade 1 or 2, were reported in 81 patients (45.8%) treated with SARCLISA® in combination with carfilzomib and dexamethasone (Grade 1 in 13.6%, Grade 2 in 31.6%, Grade 3 in 0.6%); IRRs occurred on the infusion day in 99.2% of episodes. 94.4% of those experiencing an IRR experienced it during the first cycle of treatment. All IRRs resolved, with 73.8% of IRRs resolving on the same day they were experienced, 23.8% resolving the day after, and 2.5% resolving after more than 2 days. IRRs, mostly Grade 1 or 2, were observed in 38.2% of patients treated with SARCLISA® in combination with pomalidomide and dexamethasone. All IRRs started during the first SARCLISA® infusion and resolved on the same day in most patients. To decrease the risk and severity of IRRs, patients should be premedicated prior to the SARCLISA® infusion. Vital signs should be frequently monitored during the entire SARCLISA® infusion. In the event of an IRR in which infusion interruption or intervention (Grade 2) is indicated, interrupt the SARCLISA® infusion and provide appropriate medical and supportive measures. If symptoms improve to Grade ≤1, restart SARCLISA® infusion at half 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 per the Infusion Rates of SARCLISA® Administration, consistent with the Product Monograph. If symptoms do not improve to Grade ≤1 after interruption of SARCLISA® infusion, persist or worsen despite appropriate medications, require hospitalization or are life-threatening (Grade 3 or 4), permanently discontinue SARCLISA® and institute appropriate management. SARCLISA® may cause serious infusion reactions, including anaphylactic reactions. Signs and symptoms of anaphylactic reactions include bronchospasm, dyspnea, angioedema and swelling.
Other relevant warnings and precautions:
- Interference with serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE) assays
- Interference with indirect antiglobulin test
- Driving and operating machinery
- Fertility
- Pregnancy and breastfeeding
- Second primary malignancies
- Tumour lysis syndrome
For more information:
Please consult the Product Monograph at http://products.sanofi.ca/en/sarclisa-en.pdf for important information relating to the adverse events, drug interactions and dosing information that have not been discussed in this piece.
The Product Monograph is also available by calling Sanofi Canada Medical Information at 1-800-589-6215.
Please see the SARCLISA® Product Monograph for complete prescribing information.