Isatuximab-Irfc: uses, dosing, side effects & brands
Isatuximab-Irfc is a medicine sold in the U.S. under one brand, for multiple myeloma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Multiple Myeloma
- Available as
- Injectable
- Sold as
- Sarclisa Escena
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How isatuximab-irfc is dosed
From the FDA label for Sarclisa Escena (application BLA761445). Other isatuximab-irfc products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
SARCLISA ESCENA and intravenous isatuximab-irfc have different dosage and route of administration instructions. Administer SARCLISA ESCENA only as a subcutaneous injection. Premedicate with dexamethasone, leukotriene receptor antagonist, acetaminophen, and diphenhydramine. ( 2.2 ) The recommended dosage of SARCLISA ESCENA is 1,400 mg administered as subcutaneous injection with the CirCLIQ™ On-Body Delivery System (OBDS) or with a syringe and infusion set for manual administration. See full prescribing information for SARCLISA ESCENA schedules of administration and drugs used in combination. ( 2.1 ) 2.1 Important Dosage Information SARCLISA ESCENA and intravenous isatuximab-irfc have different dosage and administration instructions [see Dosage and Administration (2.2) ] . SARCLISA ESCENA is for subcutaneous use only. Check the product label to ensure that the correct formulation (SARCLISA ESCENA or intravenous isatuximab-irfc) is being prescribed and administered. 2.2 Recommended Dosage Administer premedications before SARCLISA ESCENA administration [see Dosage and Administration (2.3) ] . SARCLISA ESCENA should be administered by a health care professional [see Warnings and Precautions (5.1) ] . Patients currently receiving intravenous isatuximab-irfc may transition to SARCLISA ESCENA solution for injection after the completion of the first cycle. The recommended dose of…
Isatuximab-Irfc side effects
The following clinically significant adverse reactions from SARCLISA ESCENA are also described in other sections of the labeling: Hypersensitivity and Other Administration Reactions [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.3) ] Second Primary Malignancies [see Warnings and Precautions (5.4) ] In combination with pomalidomide and dexamethasone : The most common adverse reactions (≥20%) are upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea. ( 6.1 ) In combination with carfilzomib and dexamethasone : The most common adverse reactions (≥20%) are upper respiratory tract infection and musculoskeletal pain. ( 6.1 ) In combination with bortezomib, lenalidomide and dexamethasone : The most common adverse reactions (≥20%) are peripheral neuropathy, constipation, diarrhea, fatigue, musculoskeletal pain, upper respiratory tract infections, injection site reaction, insomnia, edema, rash, and erythema. ( 6.1 ) The most common hematology laboratory abnormalities (≥40%) with SARCLISA ESCENA combination therapies are decreased neutrophils, decreased platelets, decreased hemoglobin, decreased leukocytes, and decreased lymphocytes. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or…
Who shouldn’t take isatuximab-irfc
SARCLISA ESCENA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients [see Warnings and Precautions (5.1) ] . Patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients. ( 4 )
Isatuximab-Irfc drug interactions
7.1 Laboratory Test Interference Interference with Serological Testing Isatuximab-irfc, an anti-CD38 antibody, may interfere with blood bank serologic tests with false positive reactions in indirect antiglobulin tests (indirect Coombs tests), antibody detection (screening) tests, antibody identification panels, and antihuman globulin crossmatches in patients treated with isatuximab-irfc [see Warnings and Precautions (5.5) ] . Interference with Serum Protein Electrophoresis and Immunofixation Tests Isatuximab-irfc may be incidentally detected by serum protein electrophoresis and immunofixation assays used for the monitoring of M-protein and may interfere with accurate response classification based on International Myeloma Working Group (IMWG) criteria [see Warnings and Precautions (5.5) ] . Because of this interference, Hydrashift assay was routinely used in IRAKLIA and IZALCO clinical studies for efficacy assessment to determine the complete response in patients with IgG kappa myeloma protein. In patients with persistent very good partial response, where interference is suspected, consider using an FDA-cleared isatuximab-irfc-specific IFE assay to distinguish isatuximab-irfc from any remaining endogenous M-protein in the patient's serum to facilitate determination of a complete response.
Every isatuximab-irfc product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Sarclisa Escena.
What people report to the FDA about isatuximab-irfc
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 50 reports naming isatuximab-irfc, and the FDA flagged 86% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- neutropenia9 reports
- urinary tract infection6 reports
- neutrophil count decreased4 reports
- platelet count decreased4 reports
- abdominal pain3 reports
- drug hypersensitivity3 reports
- headache3 reports
- hypotension3 reports
Read these as a signal, not a rate. A report does not mean isatuximab-irfc caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 30, 2026.
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Frequently asked questions
What is isatuximab-irfc?
Sarclisa Escena (Isatuximab-Irfc) is a medication used to treat Multiple Myeloma.
Can you take isatuximab-irfc with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run isatuximab-irfc against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does isatuximab-irfc come in?
Across the brands we track, isatuximab-irfc is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic isatuximab-irfc?
We do not currently list a generic-labelled isatuximab-irfc product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Isatuximab-Irfc: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/isatuximab-irfc
- MLA
- “Isatuximab-Irfc: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/isatuximab-irfc.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for isatuximab-irfc on DailyMed (NIH) ↗.