Isatuximab-irfc

Class: Antineoplastic Agents
Chemical Name: Immunoglobulin G1, anti-(human CD38 antigen) (human-Mus musculus monoclonal hu38SB19 heavy chain), disulfide with human-Mus musculus monoclonal hu38SB19 light chain, dimer
Molecular Formula: C₆₄₅₆H₉₉₃₂N₁₇₀₀O₂₀₂₆S₄₄ (peptide)
CAS Number: 1461640-62-9
Brands: Sarclisa

Medically reviewed by Drugs.com on Jul 12, 2021. Written by ASHP.

Introduction

Antineoplastic agent; a chimeric anti-CD38 monoclonal antibody.

Uses for Isatuximab-irfc

Multiple Myeloma

Used in combination with pomalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (designated an orphan drug by FDA for use in multiple myeloma).

Isatuximab-irfc Dosage and Administration

General

Administer only in settings where emergency equipment and appropriate medical support is available. (See Infusion-related Effects under Cautions.)
Because neutropenia occurs frequently, periodically monitor CBCs during therapy and consider anti-infective and antiviral prophylaxis. (See Hematologic Effects under Cautions.)
Perform blood typing and screening prior to the first isatuximab infusion. (See Interference with Laboratory Testing under Cautions.)

Premedication for Infusion-related Reactions

Administer the following premedications 15–60 minutes prior to each isatuximab infusion :

Oral or IV dexamethasone 40 mg, or a reduced dosage of 20 mg for ≥75 years of age
Oral acetaminophen 650 mg to 1 g or equivalent
Histamine H₂-antagonist
Oral or IV diphenhydramine 25–50 mg or equivalent (IV preferred for at least the first 4 doses)

Restricted Distribution

Obtain through designated specialty pharmacies and distributors.

Administration

IV Administration

Administer by IV infusion using a polyurethane (PU), polybutadiene (PBD), polyvinyl chloride (PVC), or polyethylene (PE) infusion set equipped with a nylon, polysulfone, or polyethersulfone (PES) 0.22-µm inline filter.

Do not infuse simultaneously through the same IV line with any other drug.

Dilution

Must be diluted prior to IV infusion.

Remove the volume of diluent equal to the total required volume of injection concentrate from a 250-mL bag of 0.9% sodium chloride injection or 5% dextrose injection. Add the required volume of injection concentrate to the diluent in the polyolefin, polypropylene, ethyl vinyl acetate, PVC with di-(2-ethylhexyl) phthalate (DEHP), or PE infusion bag. Gently invert bag to mix solution; do not shake.

Discard any unused portions of the injection concentrate or diluted solution.

Rate of Administration

An incremental escalation of the infusion rate may be considered in the absence of infusion-related reactions. (See Table 1.)