Sarclisa Concentrate for Solution for Infusion
Isatuximab
20mg/ml
SANOFI-AVENTIS GROUPE.
| Pack size | 1 Glass Vial (25ml) |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | CITY MEDICAL STORE |
| Retail Price | 16102.00 AED |
Available as:
Indications
Sarclisa Concentrate for Solution for Infusion is used for:
Multiple myeloma
Adult Dose
Multiple myeloma
Indicated, in combination with pomalidomide and dexamethasone, for multiple myeloma in adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor
Each cycle is 28 days
Use in combination with pomalidomide and dexamethasone
Cycle 1
10 mg/kg (actual body weight) IV qWeek (eg, Day 1, 8, 15, 22)
Cycle 2 and beyond
10 mg/kg IV q2Weeks (eg, Day 1, 15)
Continue until disease progression or unacceptable toxicity
Child Dose
Renal Dose
Administration
IV Preparation
Calculate dose required based on actual body weight
Visual inspect parenteral drug products for particulate matter and discoloration before administration
Remove the same volume of diluent from 0.9% NaCl or D5W diluent bag as the required volume of isatuximab
Withdraw the necessary volume of isatuximab and add to the 0.9% NaCl or D5W infusion bag
Infusion bag must be made of polyolefins (PO), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) with di-(2-ethylhexyl) phthalate (DEHP), or ethyl vinyl acetate (EVA)
Gently invert bag to mix; do not shake
IV Administration
Administer by IV infusion using an IV 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)
Premedications
Administer 15-60 min before infusion
Dexamethasone 40 mg PO/IV (or 20 mg PO/IV for patients aged ?75 years)
Acetaminophen 650-1000 mg PO (or equivalent)
H2-antagonist
Diphenhydramine 25-50 mg PO/IV (or equivalent); IV route is preferred for at least the first 4 infusions
Dexamethasone dose is the total dose to be administered only once before infusion as part of the premedication and of the treatment, before isatuximab and pomalidomide administration
Infusion rate
Consider incremental escalation of the infusion rate only in the absence of infusion-related reactions
First IV infusion: Start 25 mL/hr; if no reaction after 60 min, increase by 25 mL/hr q30min, not to exceed 150 mL/hr
Second IV infusion: Infuse at 50 mL/hr; if no reaction after 30 min, increase by 50 mL/hr for 30 min then increase by 100 mL/hr q30min; not to exceed 200 mL/hr
Subsequent IV infusions: Infuse at 200 mL/hr; not to exceed 200 mL/hr
Contra Indications
Severe hypersensitivity to isatuximab or to any of its excipients
Precautions
Neutropenia reported; monitor complete blood cell counts periodically; consider antibiotics and antiviral prophylaxis during treatment; if grade 4 neutropenia occurs, delay dose until neutrophil count recovery to at least 1 x 109/L, and provide supportive care with growth factors, according to institutional guidelines
Second primary malignancies (SPMs) reported; monitor for the development of SPM, as per International Myeloma Working Group guidelines
Can cause fetal harm
Pregnancy-Lactation
Pregnancy
Based on the mechanism of action, fetal harm may occur when isatuximab is administered to a pregnant woman
No data available on use in pregnant women to evaluate drug-associated risks
Animal reproduction toxicity studies have not been conducted
Clinical considerations
IgG1 monoclonal antibodies are known to cross the placenta
Based on its mechanism of action, isatuximab may cause depletion of fetal CD38-positive immune cells and decrease bone density monoclonal antibodies are known to cross the placenta
Contraception
Females: advise females of reproductive potential to use effective contraception during treatment and for at least 5 months after the last dose
Also see prescribing information for pomalidomide for further information
Lactation
Data not available on presence of isatuximab in human milk, on milk production, or effects on the breastfed child
Maternal IgF is known to be present in human milk; effects of local gastrointestinal exposure in the breastfed infant are unknown
Advise lactating women not breastfeed during treatment
Refer to the prescribing information of pomalidomide and dexamethasone for further recommendations
Interactions
Serological testing (indirect antiglobulin test)
Isatuximab binds to CD38 on red blood cells (RBCs) and may result in a false-positive indirect antiglobulin test (indirect Coombs test)
Type and screen patients before starting treatment
Inform blood bank that the patient is receiving isatuximab
If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices
Serum protein electrophoresis and immunofixation tests
Isatuximab is an IgG kappa monoclonal antibody that can be incidentally detected on both serum protein electrophoresis and immunofixation assays used for clinical monitoring of endogenous M-protein
This interference may affect the accuracy of the determination of complete response in some patients with IgG kappa myeloma protein
Adverse Effects
Side effects of Isatuximab :
>10%
All grades
Anemia (99%)
Neutropenia (96%)
Lymphopenia (92%)
Thrombocytopenia (84%)
Upper respiratory tract infection (57%)
Infusion-related reactions (38%)
Pneumonia (31%)
Diarrhea (26%)
Dyspnea (17%)
Nausea (15%)
Vomiting (12%)
Febrile neutropenia (12%)
Grade 3-4
Neutropenia (24-61%)
Lymphopenia (13-42%)
Anemia (32%)
Pneumonia (3.3-22%)
Thrombocytopenia (14-16%)
Febrile neutropenia (1.3-11%)
1-10%
Grade 3-4
Upper respiratory tract infections (9%)
Dyspnea (5%)
Diarrhea (2%)
Infusion-related reactions (1.3%)
Vomiting (1.3%)
Mechanism of Action
Anti-CD38 monoclonal antibody; monoclonal antibody that targets a specific epitope on the CD38 receptor on plasma cells that promote apoptosis and immunomodulatory activity
Note
Sarclisa 20mg/ml Concentrate for Solution for Infusion manufactured by SANOFI-AVENTIS GROUPE.. Its generic name is Isatuximab. Sarclisa is availble in United Arab Emirates.
Farmaco UAE drug index information on Sarclisa Concentrate for Solution for Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.