Isatuximab (Sarclisa)

General information

Class/mechanism from NCI Drug Dictionary: A humanized IgG1 monoclonal antibody directed against the cell surface glycoprotein CD-38 with potential antineoplastic activity. Isatuximab specifically binds to CD38 on CD38-positive tumor cells.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Multiple myeloma

History of changes in FDA indication

• 2020-03-02: Approved in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (Based on ICARIA-MM)
• 2021-03-31: Approved in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. (Based on IKEMA)

History of changes in EMA indication

• 2020-05-30: Initial authorization

History of changes in Health Canada indication

• 2020-04-29: Initial notice of compliance

History of changes in PMDA indication

• 2020-06-29: Newly indicated for the treatment of relapsed or refractory multiple myeloma.

Patient Drug Information

• Isatuximab (Sarclisa) Package Insert

Also known as

• Code name: SAR-650984
• Generic name: isatuximab-irfc
• Brand name: Sarclisa