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Isatuximab-irfc Injection

Isatuximab-irfc injection is a targeted antibody therapy used to treat multiple myeloma, both newly diagnosed and relapsed or refractory forms, in combination with other cancer medicines.

Brand names SarclisaSarclisa Escena
Drug class Cd38-directed Cytolytic Antibody
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Isatuximab-irfc Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Isatuximab-irfc (Sarclisa, Sarclisa Escena) is a lab-made antibody for multiple myeloma that latches onto CD38, a protein on myeloma cells, pushing them to self-destruct and flagging them for immune attack; on the market since about 2020, it is one of two CD38 antibodies central to myeloma combinations, always given with other cancer medicines. Doses are usually well handled, though colds, tiredness, diarrhea and dose reactions (fever, shortness of breath) are common. Watch above all for infection from low white blood cell counts, and call promptly about any fever, chills or new cough. Before any transfusion, tell blood bank staff you receive it, because it skews their tests.

Clinical pearls

  • Expect regular blood counts; low neutrophils (infection-fighting white cells) can mean a delayed dose or a shot to boost them.
  • It can also distort the protein blood tests used to track your myeloma, which your team factors into reading your response.
  • Use effective contraception during treatment and 5 months after, and follow the pregnancy safety program for any pomalidomide or lenalidomide.
  • Your team may add preventive antibacterial and antiviral medicines; keep taking them as prescribed even on days you feel fine.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection
Earliest FDA record2020
Companies listing it with the FDA1
FDA label last updatedJul 10, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Isatuximab-irfc Injection, written from its FDA label.

What Isatuximab-irfc Injection is used for

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Isatuximab-irfc injection treats multiple myeloma in adults and is always given in combination with other medicines. The supported uses across available products are:

  • Sarclisa Escena (subcutaneous) and intravenous isatuximab-irfc (Sarclisa): used with pomalidomide and dexamethasone for multiple myeloma in adults who have had at least one prior treatment that included lenalidomide and a proteasome inhibitor
  • Sarclisa Escena (subcutaneous) and intravenous isatuximab-irfc (Sarclisa): used with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma (cancer that has come back or stopped responding) after one to three prior lines of therapy
  • Sarclisa Escena (subcutaneous) and intravenous isatuximab-irfc (Sarclisa): used with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adults who are not candidates for an autologous stem cell transplant

How Isatuximab-irfc Injection works

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Isatuximab-irfc is a monoclonal antibody — a precisely engineered protein — that homes in on a molecule called CD38, which is heavily present on the surface of multiple myeloma cancer cells. When it binds to CD38, it attacks the cancer cells in several ways at once: it triggers the cells to self-destruct (apoptosis), flags them for destruction by immune cells through antibody-dependent cytotoxicity and phagocytosis, and activates the complement system (another immune defense mechanism). It also wakes up the body's natural killer (NK) cells to attack tumor cells and dials down certain immune-suppressing T-regulatory cells that would otherwise shield the cancer.

When combined with pomalidomide, the cancer-killing effects are stronger than with either medicine alone — both in laboratory studies and in animal models of human multiple myeloma.

Isatuximab-irfc Injection dosage

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Isatuximab-irfc is given by a healthcare professional in a clinical setting — you will not self-administer this at home. Sarclisa Escena is given as a subcutaneous injection into the abdomen. Intravenous isatuximab-irfc (Sarclisa) is given through an IV line. Both forms are typically given weekly during the first treatment cycle, then every two weeks — and in some regimens eventually every four weeks — as treatment continues. The exact schedule depends on which combination regimen you are on.

  • Premedications are given before each dose to lower the chance of reactions
  • Treatment continues until the disease progresses or side effects become too serious
  • If a dose of Sarclisa Escena is missed, it should be given as soon as possible and the schedule adjusted to maintain the treatment interval

Dosing details from the FDA-approved label

From the Isatuximab-irfc Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • In combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone
    • 1,400 mg administered as a subcutaneous injection with the CirCLIQ On-Body Delivery System (OBDS) or with a syringe and infusion set for manual administration
    • Cycle 1 (28-day cycle): Days 1, 8, 15, and 22 (weekly)
    • Cycle 2 and beyond (28-day cycles): Days 1 and 15 (every 2 weeks)
    • Treatment is repeated until disease progression or unacceptable toxicity
    • No dose reduction of SARCLISA ESCENA is recommended; dose delay or omission may be required.
  • In combination with bortezomib, lenalidomide, and dexamethasone
    • 1,400 mg administered as a subcutaneous injection with the CirCLIQ On-Body Delivery System (OBDS) or with a syringe and infusion set for manual administration
    • Cycle 1 (28-day cycle): Days 1, 8, 15, 22 (weekly)
    • Cycles 2 to 12 (28-day cycles): Days 1 and 15 (every 2 weeks)
    • Cycles 13 and beyond (28-day cycles): Day 1 (every 4 weeks)
    • Treatment is repeated un
    • No dose reduction of SARCLISA ESCENA is recommended; dose delay or omission may be required.
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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 SARCLISA ESCENA is 1,400 mg administered as a subcutaneous injection with the CirCLIQ On-Body Delivery System (OBDS) or with a syringe and infusion set for manual administration, in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone, or in combination with bortezomib, lenalidomide, and dexamethasone. SARCLISA ESCENA dosing schedules are provided in Tables 1 and 2 [see Clinical Studies (14) ] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Isatuximab-irfc Injection side effects

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Like most cancer medicines, isatuximab-irfc commonly affects blood counts and the immune system. Common side effects reported in clinical trials include:

Common side effects

  • Upper respiratory tract infections (colds, sinus infections)
  • Infusion-related or injection-site reactions (fever, shortness of breath)
  • Pneumonia
  • Diarrhea
  • Fatigue
  • High blood pressure
  • Decreased blood cell counts (red cells, white cells, platelets)
  • Cough
  • Infusion-related or administration reactions (fever, shortness of breath, chills)
  • Decreased hemoglobin (anemia — low red blood cells), low neutrophils, low lymphocytes, and low platelets on blood tests

When to get medical help

  • Get medical help right away for severe or life-threatening allergic reactions: sudden difficulty breathing, chest tightness, severe dizziness, or swelling of the face or throat
  • Call your doctor if you develop signs of infection: fever, chills, cough, painful urination, or any sign that won't go away — serious and fatal infections have occurred
  • Call your doctor if you notice unusual bruising or bleeding, which may signal dangerously low platelet counts
  • Tell your care team immediately if you feel extreme fatigue or look pale — this may signal severely low red or white blood cell counts
  • Let your doctor know about any new lumps, unusual growths, or symptoms — a risk of second cancers (second primary malignancies) has been identified
  • If you are pregnant or planning to become pregnant, contact your doctor immediately — this medicine can harm an unborn baby

Seek immediate medical care if you experience difficulty breathing, signs of severe infection (high fever, shaking chills), unusual bleeding or bruising, or any severe allergic reaction — these can be life-threatening.

Isatuximab-irfc Injection warnings and precautions

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  • Serious and fatal infections: Low white blood cell counts (neutropenia) are common and raise the risk of severe infections, including pneumonia. Blood counts are checked regularly throughout treatment, and your doctor may delay doses or prescribe preventive antibiotics or antiviral medicines.
  • Infusion and administration reactions: Both systemic reactions (whole-body) and local injection-site reactions can occur. Premedications before every dose help lower this risk. Severe reactions require dose interruption; life-threatening (grade 4) reactions require permanently stopping the medicine.
  • Second primary malignancies: A risk of developing a new, separate cancer has been observed. Your care team will monitor for this throughout treatment.
  • Fetal harm: This medicine can harm an unborn baby. Women who can become pregnant must use effective contraception during treatment and for 5 months after the last dose. Breastfeeding is not recommended during treatment.
  • Lab test interference: Isatuximab-irfc can cause false-positive results on certain blood bank tests (indirect Coombs test) and can interfere with tests used to track myeloma response. Always inform blood banks and lab staff that you are on this medicine.

Isatuximab-irfc Injection interactions

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Isatuximab-irfc itself does not have traditional drug-drug interactions listed, but it has important interference with laboratory tests that act like interactions in practice:

  • Blood bank serologic tests (indirect Coombs test): Isatuximab-irfc can cause false-positive results, which could complicate blood transfusion matching — always tell any blood bank or transfusion team that you are receiving this medicine
  • Serum protein electrophoresis and immunofixation tests (M-protein monitoring): The drug itself may show up on these tests, making it harder to tell whether your myeloma is responding — your doctor may use a specialized assay to work around this
  • Pomalidomide and lenalidomide (partner medicines): These combination partners have their own serious interaction profiles, pregnancy restrictions, and REMS safety programs — review their separate information carefully with your care team

Interactions listed in the FDA-approved label

From the Isatuximab-irfc Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Blood bank serologic tests (indirect antiglobulin tests, antibody detection tests, antibody identification panels, antihuman globulin crossmatches): Isatuximab-irfc, an anti-CD38 antibody, may interfere with these tests, causing false positive reactions in patients treated with isatuximab-irfc.
  • Serum protein electrophoresis and immunofixation tests: Isatuximab-irfc may be incidentally detected by these assays used for monitoring M-protein and may interfere with accurate response classification based on IMWG criteria. 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 remaining endogenous M-protein to facilitate determination of a complete response.
Read the label’s full interactions text

7 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.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Isatuximab-irfc Injection against a supplement or herb →

Before taking Isatuximab-irfc Injection

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  • Severe allergy to isatuximab-irfc or its ingredients: This medicine is contraindicated — do not receive it if you have had a serious hypersensitivity reaction to it before
  • Pregnancy: This medicine can cause fetal harm; women of childbearing potential must use effective contraception during treatment and for 5 months after the last dose
  • Breastfeeding: Do not breastfeed during treatment — effects on a nursing infant are unknown and the combination medicines (pomalidomide, lenalidomide) pose additional risks
  • Children: Safety and effectiveness have not been established in pediatric patients
  • Adults 75 and older: Neutropenia (dangerously low white blood cells) may occur more frequently; dose adjustments may be needed more often; monitoring is especially important
  • Liver impairment: The effect of moderate to severe liver disease on how the body handles this medicine is not fully known — discuss with your doctor
  • Kidney disease including dialysis: No dose adjustment is needed; kidney impairment does not meaningfully change how the body processes this medicine

What Isatuximab-irfc Injection does in the body

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In patients with multiple myeloma treated with isatuximab-irfc alongside pomalidomide and dexamethasone, measurable drops in natural killer (NK) cell counts and B-cell counts in the blood have been observed — reflecting the medicine's effect on the immune system. Higher drug levels (exposure) are associated with better overall response rates and longer progression-free survival. At up to twice the approved recommended dose, isatuximab-irfc does not cause a clinically meaningful prolongation of the QT interval (an electrical measurement of heart rhythm), meaning it does not appear to raise the risk of dangerous heart arrhythmias at therapeutic doses.

How your body processes Isatuximab-irfc Injection

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Isatuximab-irfc reaches steady-state drug levels in the blood by about 18 weeks of treatment, with roughly a 3-fold buildup over time. It is distributed in a relatively small volume, suggesting it stays largely in the bloodstream rather than spreading widely into tissues. The drug is broken down through normal protein-degradation pathways into small peptides (amino acid fragments) — the same way the body recycles other proteins. After the last dose, nearly all (99% or more) of the medicine is cleared from the blood within approximately 2 months. Age, sex, kidney disease (including dialysis), and mild liver impairment do not meaningfully change how the body processes isatuximab-irfc, so no dose adjustments are needed for those factors.

How to store Isatuximab-irfc Injection

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Store SARCLISA ESCENA vial in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until 20 minutes prior to use. Do not freeze. stored at ambient temperature between 18°C to 28°C (64°F to 82°F) for a single period of up to 24 hours.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Isatuximab-irfc Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Isatuximab-irfc Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I need to take other medicines along with this one — can't it work on its own?

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Isatuximab-irfc is designed to be used in combination, not alone. Research shows it works much better when paired with medicines like pomalidomide or carfilzomib and dexamethasone than it does by itself. Think of it like a team effort — each medicine attacks the cancer in a slightly different way, and together they're more powerful. Your care team has chosen the combination that fits your specific situation.

What should I watch for after each dose — what's normal and what's a red flag?

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Some mild reactions after a dose — like a low-grade fever or a little shortness of breath — can happen and are usually manageable. Your team gives you premedications beforehand to lower that risk. What you should call about right away: high fever, severe difficulty breathing, shaking chills, a skin rash spreading quickly, or feeling like you might faint. These could signal a serious reaction or infection that needs immediate attention. When in doubt, call your care team — that's what they're there for.

I heard this medicine can mess up blood tests. What does that mean for me?

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Yes, this is important to know. Isatuximab-irfc can show up on certain blood bank tests and cause a false-positive result — which could cause confusion if you ever need a blood transfusion. Always tell any blood bank, hospital, or new provider that you are on this medicine. It can also interfere with the tests your doctor uses to track how well your myeloma is responding to treatment, so your team may use a special test to get around that issue.

Is it safe to get vaccinated or be around people who are sick while on this treatment?

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Your immune system is weakened during this treatment, especially your white blood cell counts, so you are more vulnerable to infections. It's important to avoid close contact with people who are very sick when possible. For vaccines: live vaccines should be avoided, and if you were exposed to this medicine in the womb as a baby, live vaccines should be deferred until a doctor checks your blood. Talk to your oncologist about which vaccines are safe and when to get them — this is a conversation worth having early in your treatment.

Is it safe to get pregnant or try to have a baby while on this medicine?

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No — this medicine can cause serious harm to an unborn baby, and it should not be used during pregnancy. If you can become pregnant, you must use reliable birth control during treatment and for 5 full months after your last dose. Many of the partner medicines used alongside isatuximab-irfc, like pomalidomide and lenalidomide, also have very strict pregnancy prevention programs of their own. If there's any chance you could be pregnant, tell your doctor right away before starting treatment.

How long will I need to be on this treatment?

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Treatment is continued for as long as it's working and the side effects are manageable — there is no fixed end date set in advance. Some patients are on it for many months or even longer. The schedule typically starts with weekly injections or infusions in the first cycle, then spaces out to every two weeks or eventually every four weeks depending on your specific regimen. Your oncologist will monitor your response regularly and adjust the plan as needed.

Is Isatuximab-irfc Injection available over the counter?

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No. Isatuximab-irfc Injection is a prescription medicine: every Isatuximab-irfc Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Isatuximab-irfc Injection first available?

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The earliest FDA record we hold for Isatuximab-irfc Injection is from 2020: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Isatuximab-irfc Injection was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Isatuximab-irfc Injection on HelloPharmacist

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Detailed data & references for Isatuximab-irfc Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Isatuximab-irfc Injection forms and strengths (how it comes)

Isatuximab-irfc Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Isatuximab-irfc Injection inactive ingredients by manufacturer.

Injection

By injection · Into a vein · Under the skin
Brands Sarclisa Sarclisa Escena
How this form is used
What it may be used for
  • Sarclisa (intravenous) and Sarclisa Escena (subcutaneous) are both used with pomalidomide and dexamethasone for multiple myeloma in adults who have had at least one prior therapy including lenalidomide and a proteasome inhibitor
  • Sarclisa (intravenous) and Sarclisa Escena (subcutaneous) are both used with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma after one to three prior lines of therapy
  • Sarclisa (intravenous) and Sarclisa Escena (subcutaneous) are both used with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adults not eligible for an autologous stem cell transplant
  • Sarclisa Escena is for subcutaneous (under-the-skin) use only; intravenous isatuximab-irfc is administered into a vein — these are not interchangeable
Important instructions
  • Sarclisa Escena is given as a subcutaneous injection into the abdomen only, by a healthcare professional, using either the CirCLIQ On-Body Delivery System or a syringe and infusion set
  • Sarclisa Escena injection sites on the abdomen should be rotated with each dose, at least 1 inch from the previous site; do not inject into skin that is red, tender, scarred, or injured
  • Sarclisa Escena requires premedications (dexamethasone, a leukotriene receptor antagonist, acetaminophen, and diphenhydramine) given 15–60 minutes before each dose to reduce reaction risk
  • Patients already receiving intravenous isatuximab-irfc (Sarclisa) may transition to Sarclisa Escena after completing the first treatment cycle, as directed by their care team
Available strengths 4 strengths
100 mg/5 mL 140 mg/mL 500 mg/25 mL 1400 mg/10 mL
10 FDA-listed product records ⓘ

Isatuximab-irfc Injection on the U.S. market: products, makers and brands

How Isatuximab-irfc Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 3 Isatuximab-irfc Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2020. Brand names on the directory include Sarclisa, Sarclisa Escena; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
2
Brand names
3
FDA-listed product records ⓘ
2020
Earliest FDA record ⓘ

Compare Isatuximab-irfc Injection products

A representative set of FDA-listed product records for Isatuximab-irfc Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
100 mg/5 mL Intravenous Sanofi-Aventis U.S. LLC BLA View NDC →
140 mg/mL Subcutaneous Sanofi-Aventis U.S. LLC BLA View NDC →
500 mg/25 mL Intravenous Sanofi-Aventis U.S. LLC BLA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Isatuximab-irfc Injection NDCs →

Isatuximab-irfc Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Isatuximab-irfc recalls since July 2021.

✅No Isatuximab-irfc recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

Isatuximab-irfc Injection brand names

Isatuximab-irfc Injection is sold under 2 brand names in the FDA directory — Sarclisa, Sarclisa Escena. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Sarclisa Sarclisa Escena

Who makes Isatuximab-irfc Injection: manufacturers and labelers

One company lists Isatuximab-irfc Injection products with the FDA. By number of product records, the largest are Sanofi-Aventis U.S. LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Sanofi-Aventis U.S. LLC 3

Isatuximab-irfc Injection drug class (RxNorm)

Isatuximab-irfc Injection belongs to the CD38-directed Cytolytic Antibody class.

Pharmacologic class CD38-directed Cytolytic Antibody
Drug family (ATC) CD38 (Clusters of Differentiation 38) inhibitors
How it works CD38-directed Antibody Interactions

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Isatuximab-irfc Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Isatuximab-irfc Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Isatuximab-irfc Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
3
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Sanofi-Aventis U.S. LLC
Linked label effective
Jul 10, 2026
Composite sections available
22
Linked SPL Set ID
07730e8c-1340-4d30-8d71-e20f850db8da
Linked SPL Document ID
564889eb-80a7-336a-e063-6294a90a30c8
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sanofi-Aventis U.S. LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →