SARCLISA- isatuximab injection, solution, concentrate
sanof-aventis U.S. LLC
SARCLISA is indicated:
- in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 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.
- Administer pre-infusion medications [see Dosage and Administration (2.2)].
- SARCLISA should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions if they occur [see Warnings and Precautions (5.1)].
The recommended dose of SARCLISA is 10 mg/kg actual body weight administered as an intravenous infusion in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone, according to the schedule in Table 1 [see Clinical Studies (14)].
| Cycle||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. Treatment is repeated until disease progression or unacceptable toxicity.
SARCLISA is used in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone. For dosing instructions of combination agents administered with SARCLISA, see Clinical Studies (14) and manufacturer’s prescribing information.
Missed SARCLISA Doses
If a planned dose of SARCLISA is missed, administer the dose as soon as possible and adjust the treatment schedule accordingly, maintaining the treatment interval.
Administer the following premedications prior to SARCLISA infusion to reduce the risk and severity of infusion-related reactions [see Warnings and Precautions (5.1)]:
- When administered in combination with SARCLISA and pomalidomide: Dexamethasone 40 mg orally or intravenously (or 20 mg orally or intravenously for patients ≥75 years of age).When administered in combination with SARCLISA and carfilzomib: Dexamethasone 20 mg (intravenously on the days of SARCLISA and/or carfilzomib infusions, orally on day 22 in cycle 2 and beyond, and orally on day 23 in all cycles).
- Acetaminophen 650 mg to 1,000 mg orally (or equivalent).
- H2 antagonists
- Diphenhydramine 25 mg to 50 mg orally or intravenously (or equivalent). The intravenous route is preferred for at least the first 4 infusions.
The above recommended dose of dexamethasone (orally or intravenously) corresponds to the dose to be administered before infusion as part of the premedication and part of the backbone treatment. Administer dexamethasone before SARCLISA and pomalidomide and before SARCLISA and carfilzomib administration.
Administer the recommended premedication agents 15 to 60 minutes prior to starting a SARCLISA infusion.
No dose reduction of SARCLISA is recommended. 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)]. For information concerning drugs given in combination with SARCLISA, see manufacturer’s prescribing information.
Prepare the solution for infusion using aseptic technique as follows:
Calculate the dose (mg) of required SARCLISA based on actual patient weight (measured prior to each cycle to have the administered dose adjusted accordingly) [see Dosage and Administration (2.1)]. More than one SARCLISA vial may be necessary to obtain the required dose for the patient.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Remove the volume of diluent from the 250 mL Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP diluent bag that is equal to the required volume of SARCLISA injection.
- Withdraw the necessary volume of SARCLISA injection from the vial and dilute by adding to the infusion bag of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
- The 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 homogenize the diluted solution by inverting the bag. Do not shake.
- 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).
- The infusion solution should be administered for a period of time that will depend on the infusion rate (see Table 2). Use prepared SARCLISA infusion solution within 48 hours when stored refrigerated at 2°C–8°C, followed by 8 hours (including the infusion time) at room temperature.
- Do not administer SARCLISA infusion solution concomitantly in the same intravenous line with other agents.
- On the days where both SARCLISA and carfilzomib are administered, administer dexamethasone first, followed by SARCLISA infusion, then followed by carfilzomib infusion.
Following dilution, administer the SARCLISA infusion solution intravenously at the infusion rates presented in Table 2. Incremental escalation of the infusion rate should be considered only in the absence of infusion-related reactions [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
|Dilution Volume||Initial Rate||Absence of Infusion-Related Reaction||Rate Increment||Maximum Rate|
|First infusion||250 mL||25 mL/hour||For 60 minutes||25 mL/hour every 30 minutes||150 mL/hour|
|Second infusion||250 mL||50 mL/hour||For 30 minutes||50 mL/hour for 30 minutes then increase by 100 mL/hour||200 mL/hour|
|Subsequent infusions||250 mL||200 mL/hour||–||–||200 mL/hour|
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