Prescription medicine
Isatuximab Brand names: Sarclisa
Isatuximab (Sarclisa) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the isatuximab FDA label on DailyMed (effective July 7, 2026); every isatuximab label on DailyMed.
Highlights of the record
FDA label of July 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
Forms and strengths
- 100 mg/5ml
- 140 mg/ml
- 500 mg/25ml
Injection (solution) (concentrate); injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,605 through July 30, 2026
What is isatuximab used for?
From the label: indications and usageSARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). […]
Conditions named in the indications of isatuximab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD38-directed Cytolytic Antibody.
Source: FDA drug label (Sarclisa), Sanofi-Aventis U.S. LLC, effective July 7, 2026 (SPL set a0473462-6f9d-4eca-a5bf-8620aea68e8a), via openFDA; the full label on DailyMed
Is there a generic for isatuximab (Sarclisa)?
No generic isatuximab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the isatuximab label say about other medicines?
The isatuximab label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | To decrease the risk and severity of infusion-related reactions, premedicate patients prior to SARCLISA infusion with acetaminophen, H2 antagonists, diphenhydramine, or equivalent, and dexamethasone [see Dosage and Administration (2.2) ]. |
| Bortezomib | warnings and precautions | Systemic Administration Reactions In a pooled safety population of 411 patients with multiple myeloma who received SARCLISA ESCENA in combination with pomalidomide and dexamethasone (Pd), with carfilzomib and dexamethasone (Kd), and with bortezomib, lenalidomide, and dexamethasone (VRd) (IRAKLIA, IZALCO, and IsaSoCut … |
| Carfilzomib | warnings and precautions | Systemic Administration Reactions In a pooled safety population of 411 patients with multiple myeloma who received SARCLISA ESCENA in combination with pomalidomide and dexamethasone (Pd), with carfilzomib and dexamethasone (Kd), and with bortezomib, lenalidomide, and dexamethasone (VRd) (IRAKLIA, IZALCO, and IsaSoCut … |
| Dexamethasone | warnings and precautions | To decrease the risk and severity of infusion-related reactions, premedicate patients prior to SARCLISA infusion with acetaminophen, H2 antagonists, diphenhydramine, or equivalent, and dexamethasone [see Dosage and Administration (2.2) ]. |
| Diphenhydramine | warnings and precautions | To decrease the risk and severity of infusion-related reactions, premedicate patients prior to SARCLISA infusion with acetaminophen, H2 antagonists, diphenhydramine, or equivalent, and dexamethasone [see Dosage and Administration (2.2) ]. |
| Lenalidomide | warnings and precautions | The combination of SARCLISA with pomalidomide or lenalidomide is contraindicated in pregnant women because pomalidomide or lenalidomide may cause birth defects and death of the unborn child. |
| Pomalidomide | warnings and precautions | The combination of SARCLISA with pomalidomide or lenalidomide is contraindicated in pregnant women because pomalidomide or lenalidomide may cause birth defects and death of the unborn child. |
Source: FDA drug label (Sarclisa), Sanofi-Aventis U.S. LLC, effective July 7, 2026 (SPL set a0473462-6f9d-4eca-a5bf-8620aea68e8a), via openFDA; the full label on DailyMed
What do FAERS reports show for isatuximab?
The FDA Adverse Event Reporting System holds 5,605 reports that list isatuximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 742 are coded as a death and 2,875 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (1,313, against a median of 353 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as isatuximab?
36 other medicines are given the same way (intravenous) and in the same FDA class as isatuximab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Daratumumab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as isatuximab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to isatuximab
- 36 medicines for the same use
- Other cd38-directed cytolytic antibodys
- the pharmacologic class, with prices and generics
- Isatuximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other