SARCLISA Concentrate solution for injection Ref.[10339] Active ingredients: Isatuximab

2.1 Recommended Dosage

• 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, according to the schedule in Table 1 [see Clinical Studies (14)].

Table 1. SARCLISA Dosing Schedule in Combination with Pomalidomide and Dexamethasone:

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.

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.

2.2 Recommended Premedications

Administer the following premedications prior to SARCLISA infusion to reduce the risk and severity of infusion-related reactions [see Warnings and Precautions (5.1)]:

• Dexamethasone 40 mg orally or intravenously (or 20 mg orally or intravenously for patients ≥75 years of age).
• Acetaminophen 650 mg to 1000 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 total dose to be administered only once before infusion as part of the premedication and of the backbone treatment, before SARCLISA and pomalidomide administration.

Administer the recommended premedication agents 15 to 60 minutes prior to starting a SARCLISA infusion.

2.3 Dose Modifications

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.

For other medicinal products that are administered with SARCLISA, refer to the respective current prescribing information.

2.4 Preparation

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 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.
• 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.

2.5 Administration

• 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.

Infusion Rates

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)].

Table 2. Infusion Rates of SARCLISA Administration:

There is no known specific antidote for SARCLISA overdose. In the event of overdose of SARCLISA, monitor the patients for signs or symptoms of adverse effects and take all appropriate measures immediately.

16.2 Storage

Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake.

16.3 Handling and Disposal

Discard unused portion of solution. All materials that have been utilized for dilution and administration should be disposed of according to standard procedures.