Dosing

Dosing information for SARCLISA

Recommended Dose Administration Storage and Handling

Infusion rates of SARCLISA administration1

Incremental escalation of the infusion rate should be considered only in the absence of IRRs.

SARCLISA should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage IRRs if they occur.1

75-minute infusion time starting after the second infusion in the absence of IRRs1

Premedication1

Administer the following premedications prior to SARCLISA infusion to reduce the risk and severity of IRRs:

  • Dexamethasone 40 mg orally or IV (or 20 mg orally or IV 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 IV (or equivalent). The IV route is preferred for at least the first 4 infusions

The above recommended dose of dexamethasone (orally or IV) 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.

No post-treatment medications are required for SARCLISA

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Preparation for administration1

Prepare the solution for infusion using an 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)
  • 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

Calculating the dose of SARCLISA based on actual patient weight1

SARCLISA dosing 10 mg/kg multiplied by actual body weight

Dose modifications1

No dose reduction of SARCLISA is recommended. Dose delay may be required to allow recovery of blood counts in the event of hematological toxicity. 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.

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Storage and handling1

SARCLISA 100 mg and 500 mg vials and packaging

SARCLISA injection is a clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particulates, supplied as follows:

  • 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

Storage requirements1

  • Store SARCLISA 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

Handling and disposal1

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

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IRR=infusion-related reaction; IV=intravenous; NDC=National Drug Code; Pd=pomalidomide and dexamethasone.

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