Medicine information SARCLISA 20mg / ml concentrate for oral solution

Product code:
W66955002
Quantity:
3
Indicated for:
cancer
Route of administration:
oral
Substance:
isatuximab (monoclonal antibody)
ATC
L01FC02 — Antineoplastic and immunomodulating agents | Monoclonal antibodies and antibody drug conjugates | Cd38 (clusters of differentiation 38) inhibitors
Isatuximab is a monoclonal antibody used to treat relapsed or refractory multiple myeloma in adult patients. It works by binding to the CD38 protein on the surface of myeloma cells, activating the immune system to destroy cancer cells.

The medication is administered intravenously, usually in combination with other drugs, under the supervision of an oncologist.

Side effects may include fatigue, nausea, diarrhea, decreased blood cell counts, or infusion-related reactions. In rare cases, severe allergic reactions may occur.

Patients should be closely monitored during treatment and inform their doctor about any other medications they are taking. Pregnant or breastfeeding women should consult a specialist before use.

General data about SARCLISA 20mg / ml

Substance:
isatuximab
Date of latest medicines list:
01-04-2026
Product code:
W66955002
Strength:
20mg / ml
Pharmaceutical form:
concentrate for oral solution
Quantity:
3
Product type:
Original
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
SANOFI-AVENTIS DEUTSCHLAND GMBH - GERMANIA
Holder:
SANOFI - AVENTIS GROUPE - FRANTA
Number:
1435/2020/02
Shelf life:
3 years

Pharmaceutical forms available for isatuximab

Official documents

The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.

The correspondence between the document and the displayed text is unconfirmed.

Source institution
EMA
Document language
English
Source record: first published
12/06/2020
Source record: last updated
07/07/2026

Warnings:

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.