Sarclisa
Sarclisa ingredients
| Active ingredient | Strength |
|---|---|
| Isatuximab | 500 mg/25mL, 100 mg/5mL |
What Sarclisa is used for
The FDA lists the approved uses on the official label (below). In the EU, isatuximab is approved as Sarclisa for:
Sarclisa is indicated: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Sarclisa
- Generic name
- Isatuximab
- Made by
- Sanofi-Aventis U.S. LLC
- Forms
- Injection, Solution, Concentrate
- Given
- Intravenous
- Drug class
- CD38-directed Cytolytic Antibody
- FDA approval
- Biologic licence (BLA) BLA761113
- On the US market since
- 2020
Official information
- Sarclisa prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Isatuximab)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Sarclisa?
Sarclisa (Isatuximab) is a cancer medicine made by Sanofi-Aventis U.S. LLC, approved by the US FDA.
What are the ingredients of Sarclisa?
Sarclisa contains Isatuximab (500 mg/25mL, 100 mg/5mL).
Is Sarclisa approved in Europe?
The same active substance is approved in the EU as Sarclisa.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA