isatuximab
Sarclisa · ATC code L01XC38
Also known as: İsatuksimab
- Key facts
- Active substance
- isatuximab
- ATC code
- L01XC38
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Sarclisa 20 mg/mL concentrate for solution for infusion. · Sarclisa 1 400 mg solution for injection
- Marketing authorisation holder
- Sanofi Winthrop Industrie
- Information as of
- 2026-10-29
Key facts
Isatuximab is a monoclonal antibody against CD38 used in combination with other medicines to treat multiple myeloma in adults (Sarclisa, intravenous or subcutaneous).
What it is used for
- With pomalidomide and dexamethasone: relapsed and refractory multiple myeloma after at least two prior therapies (including lenalidomide and a proteasome inhibitor) with progression on the last therapy.
- With carfilzomib and dexamethasone: multiple myeloma after at least one prior therapy.
- With bortezomib, lenalidomide and dexamethasone: newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, and as induction in eligible patients.
Dosing
- Sarclisa 20 mg/mL concentrate (intravenous): 10 mg/kg body weight; with pomalidomide or carfilzomib, weekly in cycle 1 (days 1, 8, 15 and 22), then every 2 weeks from cycle 2 (28-day cycles).
- Sarclisa 1,400 mg solution for injection (subcutaneous): 1,400 mg; with pomalidomide or carfilzomib, weekly in cycle 1, then every 2 weeks from cycle 2.
- With bortezomib, lenalidomide and dexamethasone, different schedules with 42-day cycles apply; details: see the full text.
- Premedication 15-60 minutes before each dose with dexamethasone, montelukast (at least in cycle 1), acetaminophen and diphenhydramine (intravenously, also an H2 antagonist or proton pump inhibitor).
- No dose reduction of isatuximab is recommended; delay dosing for grade 3 or 4 neutropenia. Switching from intravenous to subcutaneous is possible once cycle 1 is completed.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Infusion reactions (intravenous, mostly mild or moderate, mainly at the first infusion) or systemic administration reactions (subcutaneous, 3.1 %).
- Neutropenia and febrile neutropenia; infections, especially pneumonia; consider antibacterial and antiviral prophylaxis.
- Second primary malignancies and tumour lysis syndrome have been reported.
- Interference with serological testing (false-positive indirect Coombs test) for at least 6 months after the last dose; interference with electrophoresis and immunofixation.
Side effects
- Intravenous with pomalidomide and dexamethasone (ICARIA-MM), most frequent: neutropenia (46.7 %), infusion reactions (38.2 %), pneumonia (30.9 %), upper respiratory tract infection (28.3 %), diarrhoea (25.7 %) and bronchitis (23.7 %).
- Subcutaneous or intravenous in combinations: infusion-related reactions (27.5%), diarrhoea (27.2%), neutropenia (25.1%), upper respiratory tract infection (23%), pneumonia (22%), fatigue (20.7%).
- Most frequent serious adverse reaction: pneumonia.
Interactions
- No impact on the pharmacokinetics of pomalidomide, carfilzomib, bortezomib or lenalidomide.
- Interference with blood bank tests (indirect antiglobulin test) and with M-protein assessment.
Pregnancy and breastfeeding
- Not recommended during pregnancy; women of childbearing potential should use effective contraception during treatment and for 7 months afterwards.
- Breast-feeding: a risk to the child in the first days after birth cannot be excluded; details: see the full text.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- SarclisaSanofi Winthrop Industrie · EMEA/H/C/004977
Source: European Medicines Agency (EMA), product information
Turkey
- SarclisaSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Sarclisa
- Liechtenstein
- Sarclisa
- Norway
- Sarclisa
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Sarclisa – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.