Administration

Administration of SARCLISA

Premedication Preparation & Administration Monitoring

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

Institution-preferred agent

Diphenhydramine

25 mg to 50 mg orally or IV (or equivalent)The IV route is preferred for at least the first 4 infusions

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

Institution-preferred agent

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.

Preparation and administration¹

Calculate the dose (mg) of required SARCLISA based on actual patient weight (measured prior to each cycle to have the administered dose adjusted accordingly). Note that more than one SARCLISA vial may be necessary to obtain the required dose for the patient.

Infusion rates of SARCLISA administration

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

First
infusion

Second
infusion

Subsequent
infusions

Dilution
volume

250 mL

Initial
rate

25 mL/h

50 mL/h

200 mL/h

Absence
of IRR

For 60 min

For 30 min

—

Rate
increment

25 mL/h
every 30 min

50 mL/h for 30 min,
then increase by 100 mL/h
every 30 min

—

Maximum
rate

150 mL/h

200 mL/h

Total time
(if no rate
adjustments)

3 h 20 min

1 h 53 min

75 min

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

Administer the infusion solution by IV infusion using an IV tubing infusion set (in PE, PVC with or without DEHP, PBD, or PU) with a 0.22-micron in-line filter (PES, polysulfone, or nylon)
The infusion solution should be administered for a period of time that will depend on the infusion rate (see the table above). Use prepared SARCLISA infusion solution within 48 hours when stored refrigerated at 36°F to 46°F (2°C to 8°C), followed by 8 hours (including the infusion time) at room temperature
Do not administer SARCLISA infusion solution concomitantly in the same IV line with other agents

SARCLISA Dosing Guide

For detailed dosing and administration information, download the PDF now

Monitoring patients¹

Administration adjustments should be made if patients experience the following adverse reactions.

IRRs

Monitor vital signs frequently during the entire SARCLISA infusion
For patients with grade 1 or 2 reactions, interrupt SARCLISA infusion and provide appropriate medical support
- If symptoms improve, restart SARCLISA infusion at half of 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
- If symptoms do not improve or recur after interruption, permanently discontinue SARCLISA and institute appropriate management
If a grade 3 or higher IRR occurs, permanently discontinue SARCLISA therapy and institute appropriate medical management

Neutropenia

Monitor complete blood cell counts periodically during treatment
Consider the use of antibiotics and antiviral prophylaxis during treatment
Monitor patients with neutropenia for signs of infection
If grade 4 neutropenia occurs, consider dose delays until neutrophil count recovery to at least 1.0 × 10⁹/L, and institute supportive care with growth factors, according to institutional guidelines

No dose reduction of SARCLISA is recommended

Interference with serological testing

SARCLISA, an anti-CD38 antibody, may interfere with blood bank serological tests with false-positive reactions in indirect antiglobulin tests (indirect Coombs tests), antibody detection (screening) tests, antibody identification panels, and antihuman globulin crossmatches in patients treated with SARCLISA.

Conduct blood type and screen tests in patients before the first infusion of SARCLISA
Consider phenotyping prior to starting treatment with SARCLISA
- If treatment with SARCLISA has already begun, inform the blood bank that the patient is receiving SARCLISA and SARCLISA interference with blood compatibility testing can be resolved using dithiothreitol-treated RBCs
If an emergency transfusion is required, non–cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices

Patient ID

Provide this document to your patients so they can easily inform other HCPs that they are receiving SARCLISA if they need to receive a blood transfusion

Storage and Handling Flashcard

A quick reference tool for SARCLISA storage and handling information

Back to topTop Mechanism of Action

Reference: 1. SARCLISA [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC.

Administration of SARCLISA

Premedication¹

Preparation and administration¹

Infusion rates of SARCLISA administration

Monitoring patients¹

IRRs

Neutropenia

Interference with serological testing

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Administration of SARCLISA

Premedication1

Preparation and administration1

Infusion rates of SARCLISA administration

Monitoring patients1

IRRs

Neutropenia

Interference with serological testing

Premedication¹

Preparation and administration¹

Monitoring patients¹