Quick answers
- What is Isatuximab used for?
- The FDA-approved label (Sarclisa, Sanofi-Aventis U.S. LLC, July 7, 2026) says: “SARCLISA 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Isatuximab have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Isatuximab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Isatuximab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Isatuximab?
- 1 company lists prescription products of Isatuximab in the FDA NDC Directory, including Sanofi-Aventis U.S. LLC.
What Isatuximab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SARCLISA 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. …
— FDA label: Sarclisa, Sanofi-Aventis U.S. LLC, effective July 7, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate · Injection, solution |
|---|---|
| Route | Intravenous · Subcutaneous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Sarclisa, Sarclisa Escena |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sanofi-Aventis U.S. LLC3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761113 SARCLISA | Sanofi Aventis Us | March 2, 2020 | 8, latest June 26, 2026 2026: Labeling · 2024: Efficacy · 2024: Efficacy |
| BLA761445 SARCLISA ESCENA | Sanofi-Aventis U.S. LLC | July 9, 2026 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sarclisa, Sanofi-Aventis U.S. LLC, effective July 7, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →