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Sarclisa Escena isatuximab-irfc 140 mg/mL Injection, Solution — NDC 00024-0674-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sarclisa Escena isatuximab-irfc 140 mg/mL Injection, Solution — NDC 0024-0674-01 (Billing 00024-0674-01)

by Sanofi-Aventis U.S. LLC · 1 VIAL in 1 CARTON / 10 mL in 1 VIAL

This is a package of Sarclisa Escena isatuximab-irfc 140 mg/mL Injection, Solution from Sanofi-Aventis U.S. LLC, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 00024-0674-01
🏷️ FDA NDC (as labeled) 0024-0674-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0024-0674-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0024 labeler · 0674 product · 01 package
Package marketed since
Jul 9, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0024067401 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0024-0674-01
Product NDC 0024-0674
11-digit billing NDC 00024067401
NCPDP billing unit ML — per mL (volume)
RxCUI 2747132, 2747135
UNII R30772KCU0
Application # BLA761445
SPL Set ID 07730e8c-1340-4d30-8d71-e20f850db8da
Established class (EPC) CD38-directed Cytolytic Antibody
Mechanism of action CD38-directed Antibody Interactions
Chemical class Antibodies, Monoclonal
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-09
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance ISATUXIMAB
Biologic (Purple Book) 351(a)
Quick answers
  • RxCUI (RxNorm): 2747132
Why two NDCs? The FDA registers this code as 0024-0674-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00024-0674-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Isatuximab-irfc injection is used to treat certain types of multiple myeloma (a type of cancer of the bone marrow). Isatuximab-irfc injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
  • Why do I need to take other medicines along with this one — can't it work on its own?
  • 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...
  • What should I watch for after each dose — what's normal and what's a red flag?
📖 Read our full Isatuximab-irfc Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00024-0674-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 2026-07-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sarclisa Escena 140 mg/mLthis 00024-0674-01 Sanofi-Aventis 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2020
First FDA approval
Mar 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2032. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 2, 2020 ⏳ ~5.4 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Sarclisaisatuximab-irfc
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2020 2022 2024 2026 2028 2030 2032
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateMar 2, 2032
Common questions
Is there a biosimilar for this drug?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Isatuximab-irfc Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 23.2 mg / 1 mL UNII F7LTH1E20Y
    Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
  • 0.82 mg / 1 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 0.78 mg / 1 mL UNII 1D5Q932XM6
    An amino acid salt used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in liquid formulations to keep the drug stable and effective.
  • 4 mg / 1 mL UNII LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • 20 mg / 1 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSanofi-Aventis U.S. LLC
FDA applicationBLA761445 (BLA)
Labeler code00024
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio85 products on file

More NDCs from Sanofi-Aventis U.S. LLC labeler code 00024

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 193 words ▾

1 INDICATIONS AND USAGE SARCLISA ESCENA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).

SARCLISA ESCENA is a CD38-directed cytolytic antibody indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1Important 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.

2.2Recommended 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) ] . Table 1: SARCLISA ESCENA Dosing Schedule in Combination with Pomalidomide and Dexamethasone or in Combination with Carfilzomib and Dexamethasone Cycles Dosing schedules 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) Table 2: SARCLISA ESCENA Dosing Schedule in Combination with Bortezomib, Lenalidomide, and Dexamethasone Cycles Dosing schedule 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 until disease progression or unacceptable toxicity.

SARCLISA ESCENA is used in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone or in combination with bortezomib, lenalidomide, and dexamethasone. For dosing instructions of combination agents administered with SARCLISA ESCENA, see Clinical Studies (14) and manufacturer's prescribing information. Missed SARCLISA ESCENA Doses If a planned dose of SARCLISA ESCENA is missed, administer the dose as soon as possible and adjust the treatment schedule accordingly, maintaining the treatment interval.

2.3Recommended Premedications and Antimicrobial Prophylaxis Recommended Premedications Administer the following premedications 15 to 60 minutes prior to SARCLISA ESCENA administration to reduce the risk and severity of systemic administration reactions [see Warnings and Precautions (5.1) ] : When administered in combination with SARCLISA ESCENA and pomalidomide: Dexamethasone 40 mg orally or intravenously (or 20 mg orally or intravenously for patients 75 years of age or older). When administered in combination with SARCLISA ESCENA and carfilzomib: Dexamethasone 20 mg orally or intravenously.

When administered in combination with SARCLISA ESCENA, bortezomib, and lenalidomide: Dexamethasone 20 mg orally. Leukotriene receptor antagonist, at cycle 1 only (Days 1, 8, 15, and 22). Acetaminophen 650 mg to 1,000 mg orally.

Diphenhydramine 25 mg to 50 mg orally or intravenously (or equivalent). The intravenous route of… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS SARCLISA ESCENA is a clear to slightly opalescent, colorless to slightly yellow solution, that may contain a few translucent to white particles, available as: Injection: 1,400 mg/10 mL (140 mg/mL) solution in a single-dose vial. Injection: 1,400 mg/10 mL (140 mg/mL) solution in single-dose vial ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS 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 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions: In case of grade ≥2 systemic administration reaction (SAR), interrupt SARCLISA ESCENA and manage medically. In case of grade 4 SAR, permanently discontinue SARCLISA ESCENA. ( 5.1 ) Neutropenia : Monitor complete blood cell counts periodically during treatment.

Monitor patients with neutropenia for signs of infection. SARCLISA ESCENA dose delays and the use of colony-stimulating factor may be required to allow improvement of neutrophil count. ( 5.2 ) Infections : SARCLISA ESCENA may cause serious and fatal infections.

Monitor patients for signs and symptoms of infection and treat appropriately. ( 5.3 ) Second Primary Malignancies (SPM) : Monitor patients for the development of second primary malignancies. ( 5.4 ) Laboratory Test Interference : Interference with Serological Testing (Indirect Antiglobulin Test): Type and screen patients prior to starting treatment.

Inform blood banks that a patient has received isatuximab-irfc. ( 5.5 , 7.1 ) Interference with Serum Protein Electrophoresis and Immunofixation Tests: isatuximab-irfc may interfere with the assays used to monitor M-protein, which may impact the determination of complete response. ( 5.5 , 7.1 ) Embryo-Fetal Toxicity : Can cause fetal harm.

Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 )

5.1Hypersensitivity and Other Administration Reactions SARCLISA ESCENA can cause both systemic administration-related reactions (SARs), including severe or life-threatening reactions, and local injection-site reactions. Systemic Administration Reactions In a pooled safety population of 411 patients with multiple myeloma who received SARCLISA ESCENA in combination with pomalidomide and dexamethasone (Pd), with carfilzomib and dexamethasone (Kd), and with bortezomib, lenalidomide, and dexamethasone (VRd) (IRAKLIA, IZALCO, and IsaSoCut, respectively, N=411), SARs occurred in 3.2% (Grade 1: 2.2%, Grade 2: 0.7%, Grade 3: 0.2%) of patients.

SARs occurred at the first administration in 1.9% of patients and at subsequent administrations in 1.5% of patients. The median time to onset was 4 hours (range: 12 minutes to 3 days). The most frequently reported symptoms of SARs (all below 1%) were pyrexia and dyspnea, and Grade ≥3 symptoms was dyspnea (not collected in IsaSoCut study) [see Dosage and Administration (2.3) and Adverse Reactions (6.1) ] .

In multiple myeloma clinical trials with intravenous isatuximab-irfc, anaphylactic reactions occurred in <1% of patients. To decrease the risk and severity of SARs, premedicate patients prior to SARCLISA ESCENA administration with leukotriene receptor antagonists (at cycle 1 only), acetaminophen, diphenhydramine, or equivalent, and dexamethasone [see Dosage and Administration (2.2) ] . In case of grade 2 SAR during SARCLISA ESCENA administration, stop current administration and do not complete it.

Administer additional premedication, as needed, for subsequent SARCLISA ESCENA administration. In case of grade 3 SAR during SARCLISA ESCENA administration, stop current administration and do not complete it. SARCLISA ESCENA administration may be resumed at the next planned administration.

In case of a third occurrence of a grade 3 SAR, permanently discontinue SARCLISA ESCENA treatment. In case of grade 4 SAR, permanently discontinue SARCLISA ESCENA treatment. Injection Site Reactions In clinical trials of SARCLISA ESCENA in combination with Pd, Kd, or VRd (IRAKLIA, IZALCO, and IsaSoCut, respectively, N=411), injection site reactions (ISRs) with SARCLISA ESCENA administration were reported in 9% (8% Grade 1 and 1.5% Grade 2) of patients and in 0.86% of injections.

Among the SARCLISA ESCENA injections with ISRs, 82% occurred the day of the administration and 4.2% were delayed by at least 3 days. With SARCLISA ESCENA-Pd and SARCLISA ESCENA-Kd, 5% of patients experienced symptoms of ISR (not collected in IsaSoCut study). The most… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS 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 www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed and/or Refractory Multiple Myeloma Combination treatment with pomalidomide and dexamethasone (SARCLISA ESCENA-Pd versus intravenous isatuximab-irfc-Pd) IRAKLIA The safety of SARCLISA ESCENA was evaluated in IRAKLIA, a randomized, open-label phase 3 clinical trial in patients with previously treated multiple myeloma.

Patients received SARCLISA ESCENA 1,400 mg administered subcutaneously, weekly in the first cycle and every two weeks thereafter, in combination with pomalidomide and dexamethasone (SARCLISA ESCENA-Pd, n=263) or isatuximab-irfc administered intravenously in combination with pomalidomide and dexamethasone (intravenous isatuximab-irfc-Pd, n=264) [see Clinical Studies (14) ] . Among patients receiving SARCLISA ESCENA-Pd, 66% were exposed to SARCLISA ESCENA for 6 months or longer and 25% were exposed for greater than 12 months or longer.

The median duration of the injection with OBDS was 13 minutes. Serious adverse reactions occurred in 53% of patients receiving SARCLISA ESCENA-Pd. Serious adverse reactions in ≥5% of patients who received SARCLISA ESCENA-Pd included pneumonia (20.5%).

Fatal adverse reactions occurred in 4.9% of patients who received SARCLISA ESCENA-Pd, including pneumonia (1.5%), sepsis/septic shock (1.5%), death (0.8%), COVID-19, lower respiratory tract infection, hemorrhagic stroke, and sudden death (0.4% each). Permanent treatment discontinuation due to an adverse reaction occurred in 8% of patients who received SARCLISA ESCENA-Pd. Adverse reactions which resulted in permanent discontinuation of SARCLISA ESCENA-Pd in more than 1 patient included pneumonia, death, COVID-19, sepsis, anemia, and neutrophil count decreased.

The most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea. The most common hematology laboratory abnormalities (≥40%) were decreased leukocytes, decreased neutrophils, decreased lymphocytes, decreased platelets, and decreased hemoglobin. Table 3 summarizes the adverse reactions in IRAKLIA.

Table 3: Adverse Reactions (≥10%) in Patients Who Received SARCLISA ESCENA-Pd or Intravenous Isatuximab-irfc-Pd in IRAKLIA Adverse Reaction SARCLISA ESCENA-Pd (N=263) Intravenous isatuximab-irfc-Pd (N=264) All Grades (%) G… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 172 words ▾

7 DRUG INTERACTIONS

7.1Laboratory 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.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1) ] , SARCLISA ESCENA can cause fetal harm when administered to a pregnant woman. There are no available data on SARCLISA ESCENA use in pregnant women to evaluate for a drug-associated risk. The assessment of isatuximab-irfc-associated risks is based on its mechanism of action and data from target antigen CD38 knockout animal models (see Data ).

No animal reproduction studies were conducted with isatuximab-irfc. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

The combination of SARCLISA ESCENA and pomalidomide or lenalidomide is contraindicated in pregnant women because pomalidomide and lenalidomide may cause birth defects and death of the unborn child. Refer to the pomalidomide or lenalidomide prescribing information on use during pregnancy. Pomalidomide and lenalidomide are only available through a REMS program.

Clinical Considerations Fetal/neonatal adverse reactions Immunoglobulin G1 monoclonal antibodies are known to cross the placenta. Based on its mechanism of action, SARCLISA ESCENA may cause depletion of fetal CD38-positive immune cells and decreased bone density. Defer administration of live vaccines to neonates and infants exposed to SARCLISA ESCENA in utero until a hematology evaluation is completed.

Data Animal data Mice that were genetically modified to eliminate all CD38 expression (CD38 knockout mice) had reduced bone density which recovered 5 months after birth. Data from studies using CD38 knockout animal models also suggest the involvement of CD38 in regulating humoral immune responses (mice), feto-maternal immune tolerance (mice), and early embryonic development (frogs).

8.2Lactation Risk Summary There are no data on the presence of isatuximab-irfc in human milk or the effects on the breastfed child or milk production. Maternal immunoglobulin G is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to SARCLISA ESCENA are unknown.

Because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with SARCLISA ESCENA and for 7 months after the last dose.

8.3Females and Males of Reproductive Potential SARCLISA ESCENA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating SARCLISA ESCENA. With the combination of SARCLISA ESCENA with pomalidomide or lenalidomide, refer to the pomalidomide or lenalidomide labeling for pregnancy testing requirements prior to initiating treatment in females of reproductive potential.

Contraception Females Advise females of reproductive potential to use effective contraception during treatment with SARCLISA ESCENA and for 7 months after the last dose. Additionally, refer to the pomalidomide or lenalidomide labeling for contraception requirements prior to initiating treatment in females of reproductive potential. Males Refer to the pomalidomide or lenalidomide prescribing information.

8.4Pediatric Use The safety and effectiveness of SARCLISA ESCENA in pediatric patients have not been established.

8.5Geriatric Use Of the total number of patients in IRAKLIA, IZALCO, and IsaSoCut clinical studies of SARCLISA ESCENA (N=411), 38% (156 patients) were less than 65, 40% (166 patients) were 65–74, and 22% (89 patients) were 75 and over. Differences in safety were observed between older versus younger age groups. Grade ≥3 TEAEs were reported in 74% of patients less than 65, in 81% of patients 65–74, and in 81% of patients 75 and above.

Fatal adverse r… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1) ] , SARCLISA ESCENA can cause fetal harm when administered to a pregnant woman. There are no available data on SARCLISA ESCENA use in pregnant women to evaluate for a drug-associated risk. The assessment of isatuximab-irfc-associated risks is based on its mechanism of action and data from target antigen CD38 knockout animal models (see Data ).

No animal reproduction studies were conducted with isatuximab-irfc. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

The combination of SARCLISA ESCENA and pomalidomide or lenalidomide is contraindicated in pregnant women because pomalidomide and lenalidomide may cause birth defects and death of the unborn child. Refer to the pomalidomide or lenalidomide prescribing information on use during pregnancy. Pomalidomide and lenalidomide are only available through a REMS program.

Clinical Considerations Fetal/neonatal adverse reactions Immunoglobulin G1 monoclonal antibodies are known to cross the placenta. Based on its mechanism of action, SARCLISA ESCENA may cause depletion of fetal CD38-positive immune cells and decreased bone density. Defer administration of live vaccines to neonates and infants exposed to SARCLISA ESCENA in utero until a hematology evaluation is completed.

Data Animal data Mice that were genetically modified to eliminate all CD38 expression (CD38 knockout mice) had reduced bone density which recovered 5 months after birth. Data from studies using CD38 knockout animal models also suggest the involvement of CD38 in regulating humoral immune responses (mice), feto-maternal immune tolerance (mice), and early embryonic development (frogs).

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use The safety and effectiveness of SARCLISA ESCENA in pediatric patients have not been established.

🧓 Geriatric Use 198 words ▾

8.5Geriatric Use Of the total number of patients in IRAKLIA, IZALCO, and IsaSoCut clinical studies of SARCLISA ESCENA (N=411), 38% (156 patients) were less than 65, 40% (166 patients) were 65–74, and 22% (89 patients) were 75 and over. Differences in safety were observed between older versus younger age groups. Grade ≥3 TEAEs were reported in 74% of patients less than 65, in 81% of patients 65–74, and in 81% of patients 75 and above.

Fatal adverse reactions were reported in 3.2% of patients less than 65, in 7% of patients 65–74, and in 9% of patients 75 and above; serious adverse reactions were reported in 44% of patients less than 65, in 50% of patients 65–74, and in 56% of patients 75 and above. In IRAKLIA, IZALCO, and IsaSoCut clinical studies of SARCLISA ESCENA (N=411) no overall differences in effectiveness of SARCLISA ESCENA have been observed between patients 65 years of age and older and younger adult patients. In the IMROZ trial, which evaluated intravenous isatuximab-irfc-VRd in the transplant ineligible newly diagnosed patient population, the hazard ratio for overall survival (OS) in patients 75 years of age and older was 1.25 [95% CI: 0.68 to 2.3].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Isatuximab-irfc is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab-irfc induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). Isatuximab-irfc inhibits the ADP-ribosyl cyclase activity of CD38.

Isatuximab-irfc can activate natural killer (NK) cells in the absence of CD38-positive target tumor cells and suppresses CD38-positive T-regulatory cells. The combination of isatuximab-irfc and pomalidomide enhanced ADCC activity and direct tumor cell killing compared to that of isatuximab-irfc alone in vitro, and enhanced antitumor activity compared to the activity of isatuximab-irfc or pomalidomide alone in a human multiple myeloma xenograft model.

12.2Pharmacodynamics In multiple myeloma patients treated with SARCLISA ESCENA in combination with Pd, a decrease in CD38-positive NK cells was assessed and observed in bone marrow. Exposure-Response Relationship The exposure-response relationship and the time course of pharmacodynamics of subcutaneously administered isatuximab-irfc have not been fully characterized. Cardiac Electrophysiology Isatuximab-irfc as a large protein has a low likelihood of direct ion channel interactions.

There is no evidence from non-clinical or clinical data to suggest that SARCLISA ESCENA subcutaneous dosage has the potential to delay ventricular repolarization.

12.3Pharmacokinetics Isatuximab-irfc pharmacokinetics were characterized in patients with relapsed and/or refractory multiple myeloma in IRAKLIA study and are presented as mean (CV%) unless otherwise specified. Following the recommended dosage of SARCLISA ESCENA, the median time to reach steady state was 22 weeks (Cycle 6) with 4.9-fold accumulation for trough concentration (C trough ). The predicted maximum plasma concentration (C max ), C trough and area under the plasma concentration time curve (AUC 2weeks ) at steady state (Cycle 6) were 594 µg/mL (45.7%), 493 µg/mL (51.1%), and 188,000 µg.h/mL (47.3%), respectively.

When comparing isatuximab-irfc exposures following the recommended SARCLISA ESCENA subcutaneous dosage to the recommended intravenous isatuximab-irfc dosage in Study IRAKLIA [see Clinical Studies (14) ] , the geometric mean ratios (GMRs) (90% CI) for observed steady state C trough (pre-dose at Cycle 6 day 1) was 1.53 (90% CI: 1.32–1.78). Absorption Following subcutaneous administration, isatuximab-irfc absolute bioavailability is 76% with a median time to reach maximum concentration (T max ) of approximately 4 days.

Distribution The total volume of distribution of isatuximab-irfc is 5.53 (21.1%) L. Metabolism Isatuximab-irfc is expected to be metabolized into small peptides by catabolic pathways. Elimination Isatuximab-irfc is eliminated by two parallel pathways, a nonlinear target-mediated pathway predominating at low concentrations, and a nonspecific linear pathway predominating at higher concentrations.

In the therapeutic plasma concentrations range, the linear pathway is largely predominant. Isatuximab-irfc linear clearance decreases over time by approximately 60% to a steady state value of 0.00479 (34.0%) L/h. The associated terminal half-life at steady state is 40.3 (30.8%) days.

Specific Populations The following factors have no clinically meaningful effect on the exposure of isatuximab-irfc: age (31 to 86 years, 18% patients were ≥75 years old), sex, race (White 66%, Asian 15%), renal impairment including patients with End-Stage Renal Disease (ESRD) or on dialysis (eGFR <90 mL/min/1.73 m 2 ), and mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN, or total bilirubin >1 to 1.5 × ULN and any AST). The effect of moderate to severe h… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 123 words ▾

12.1Mechanism of Action Isatuximab-irfc is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab-irfc induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). Isatuximab-irfc inhibits the ADP-ribosyl cyclase activity of CD38.

Isatuximab-irfc can activate natural killer (NK) cells in the absence of CD38-positive target tumor cells and suppresses CD38-positive T-regulatory cells. The combination of isatuximab-irfc and pomalidomide enhanced ADCC activity and direct tumor cell killing compared to that of isatuximab-irfc alone in vitro, and enhanced antitumor activity compared to the activity of isatuximab-irfc or pomalidomide alone in a human multiple myeloma xenograft model.

📦 How Supplied / Storage and Handling 215 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SARCLISA ESCENA (isatuximab-irfc) injection is a clear to slightly opalescent, colorless to slightly yellow solution, supplied as follows: One 1,400 mg/10 mL (140 mg/mL) single-dose vial in a carton: NDC 0024-0674-01 The vial stopper is not made with natural rubber latex. CirCLIQ OBDS (Filling Base and Wearable On-Body Injector for single use) for SARCLISA ESCENA is packaged separately from SARCLISA ESCENA vial. Storage 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. Do not shake. Unpunctured vials may be stored at ambient temperature between 18°C to 28°C (64°F to 82°F) for a single period of up to 24 hours.

Once the vial has been taken out of the refrigerator, it must not be returned to the refrigerator. Store CirCLIQ OBDS in its unopened plastic packaging inside of the original carton, in a clean, dry area away from heat and sunlight at a temperature between 2°C to 30°C (36°F to 86°F). Refer to the CirCLIQ IFU for full instructions on CirCLIQ.

Handling and Disposal Discard unused portion of solution. All materials that have been utilized for preparation and administration should be disposed of according to standard procedures.

📦 Storage and Handling 146 words ▾

Storage 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. Do not shake.

Unpunctured vials may be stored at ambient temperature between 18°C to 28°C (64°F to 82°F) for a single period of up to 24 hours. Once the vial has been taken out of the refrigerator, it must not be returned to the refrigerator. Store CirCLIQ OBDS in its unopened plastic packaging inside of the original carton, in a clean, dry area away from heat and sunlight at a temperature between 2°C to 30°C (36°F to 86°F).

Refer to the CirCLIQ IFU for full instructions on CirCLIQ. Handling and Disposal Discard unused portion of solution. All materials that have been utilized for preparation and administration should be disposed of according to standard procedures.

📋 Description 133 words ▾

11 DESCRIPTION Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa.

SARCLISA ESCENA (isatuximab-irfc) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, in a single-dose vial for subcutaneous use. Each vial contains 1,400 mg/10 mL at a concentration of 140 mg/mL with a pH of 6.2. Each mL of solution contains 140 mg isatuximab-irfc, arginine hydrochloride (23.2 mg), histidine (0.82 mg), histidine hydrochloride monohydrate (0.78 mg), poloxamer 188 (4.0 mg), sucrose (20.0 mg), and Water for Injection, USP.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Systemic Administration Reactions Advise patients to seek immediate medical attention for any of the following signs and symptoms of systemic administration reaction: shortness of breath, wheezing or trouble breathing; swelling of the face, mouth, throat, or tongue; throat tightness; palpitations; dizziness, lightheadedness, or fainting; headache; cough; rash or itching; nausea; runny or stuffy nose; or chills [see Warnings and Precautions (5.1) ] .

Neutropenia Inform patients about the risk of neutropenia and infection during SARCLISA ESCENA treatment and the importance of reporting immediately any fever or symptoms of infection to their healthcare provider [see Warnings and Precautions (5.2) ] . Infections Inform patients about the risk of developing infections during SARCLISA ESCENA treatment, and to report immediately any fever or symptoms of infection to their healthcare provider [see Warnings and Precautions (5.3) ] . Second Primary Malignancies Inform patients of the risk of developing second primary malignancies during treatment with SARCLISA ESCENA when given with pomalidomide and dexamethasone or with carfilzomib and dexamethasone, or with bortezomib, lenalidomide, and dexamethasone [see Warnings and Precautions (5.4) ] .

Cardiac Toxicities Inform patients about the risk of cardiac failure during treatment with SARCLISA ESCENA when given with carfilzomib and dexamethasone, and the importance of reporting immediately any difficulty breathing, cough, or leg swelling to their healthcare provider [see Adverse Reactions (6.1) ] . Interference with Laboratory Tests Advise patients to inform healthcare providers and transfusion center personnel that they are treated with SARCLISA ESCENA in case a red blood cell transfusion is planned. Advise patients that SARCLISA ESCENA may affect the results of blood tests to match their blood type for at least 6 months after their last administration of SARCLISA ESCENA [see Warnings and Precautions (5.5) and Drug Interactions (7.1) ] .

Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with SARCLISA ESCENA and for 7 months after the last dose [see Use in Specific Populations (8.3) ] .

Advise patients that pomalidomide or lenalidomide have the potential to cause fetal harm and have specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm. Advise patients to report suspected or known pregnancies. Pomalidomide and lenalidomide are only available through a REMS program [see Use in Specific Populations (8.1 , 8.3) ] .

Lactation Advise women not to breastfeed during treatment with SARCLISA ESCENA and for 7 months after the last dose [see Use in Specific Populations (8.2) ] .

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Isatuximab-irfc pharmacokinetics were characterized in patients with relapsed and/or refractory multiple myeloma in IRAKLIA study and are presented as mean (CV%) unless otherwise specified. Following the recommended dosage of SARCLISA ESCENA, the median time to reach steady state was 22 weeks (Cycle 6) with 4.9-fold accumulation for trough concentration (C trough ). The predicted maximum plasma concentration (C max ), C trough and area under the plasma concentration time curve (AUC 2weeks ) at steady state (Cycle 6) were 594 µg/mL (45.7%), 493 µg/mL (51.1%), and 188,000 µg.h/mL (47.3%), respectively.

When comparing isatuximab-irfc exposures following the recommended SARCLISA ESCENA subcutaneous dosage to the recommended intravenous isatuximab-irfc dosage in Study IRAKLIA [see Clinical Studies (14) ] , the geometric mean ratios (GMRs) (90% CI) for observed steady state C trough (pre-dose at Cycle 6 day 1) was 1.53 (90% CI: 1.32–1.78). Absorption Following subcutaneous administration, isatuximab-irfc absolute bioavailability is 76% with a median time to reach maximum concentration (T max ) of approximately 4 days.

Distribution The total volume of distribution of isatuximab-irfc is 5.53 (21.1%) L. Metabolism Isatuximab-irfc is expected to be metabolized into small peptides by catabolic pathways. Elimination Isatuximab-irfc is eliminated by two parallel pathways, a nonlinear target-mediated pathway predominating at low concentrations, and a nonspecific linear pathway predominating at higher concentrations.

In the therapeutic plasma concentrations range, the linear pathway is largely predominant. Isatuximab-irfc linear clearance decreases over time by approximately 60% to a steady state value of 0.00479 (34.0%) L/h. The associated terminal half-life at steady state is 40.3 (30.8%) days.

Specific Populations The following factors have no clinically meaningful effect on the exposure of isatuximab-irfc: age (31 to 86 years, 18% patients were ≥75 years old), sex, race (White 66%, Asian 15%), renal impairment including patients with End-Stage Renal Disease (ESRD) or on dialysis (eGFR <90 mL/min/1.73 m 2 ), and mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN, or total bilirubin >1 to 1.5 × ULN and any AST). The effect of moderate to severe hepatic impairment (total bilirubin >1.5 × ULN and any AST) on isatuximab-irfc pharmacokinetics is unknown.

The effect of Black or African American (2.6%) race on the exposure of isatuximab-irfc is unknown. Body weight In patients who received the recommended SARCLISA ESCENA subcutaneous dosage, the steady state C trough and AUC 2weeks were 44% and 41% lower in the higher body weight (BW) group (>100 kg), and 24% and 26% higher in the lower BW group (≤50 kg), compared to the patients with BW of 51 kg–100 kg, respectively. The pharmacokinetics differences were not clinically meaningful across body weight categories.

🧬 Pharmacodynamics 86 words ▾

12.2Pharmacodynamics In multiple myeloma patients treated with SARCLISA ESCENA in combination with Pd, a decrease in CD38-positive NK cells was assessed and observed in bone marrow. Exposure-Response Relationship The exposure-response relationship and the time course of pharmacodynamics of subcutaneously administered isatuximab-irfc have not been fully characterized. Cardiac Electrophysiology Isatuximab-irfc as a large protein has a low likelihood of direct ion channel interactions.

There is no evidence from non-clinical or clinical data to suggest that SARCLISA ESCENA subcutaneous dosage has the potential to delay ventricular repolarization.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Relapsed and/or Refractory Multiple Myeloma IRAKLIA (SARCLISA ESCENA-Pd vs intravenous isatuximab-irfc-Pd) The efficacy and safety of SARCLISA ESCENA administered subcutaneously in combination with pomalidomide and dexamethasone (SARCLISA ESCENA-Pd) were evaluated in IRAKLIA (NCT05405166), a multicenter, multinational, randomized, open-label, 2-arm, phase 3 study in patients with relapsed and/or refractory multiple myeloma. Patients had received at least one prior therapy including lenalidomide and a proteasome inhibitor.

Patients were eligible for inclusion if they had an Eastern Cooperative Oncology Group (ECOG) status of 0–2, platelets ≥50,000 cells/mm 3 , absolute neutrophil count ≥1 × 10 9 /L, creatinine clearance ≥30 mL/min/1.73 m 2 (MDRD formula), AST ≤3 × ULN, and ALT ≤3 × ULN. Treatment was administered in both arms in 28-day cycles until disease progression or unacceptable toxicity. In both treatment arms, isatuximab-irfc was administered weekly in the first cycle and every two weeks thereafter.

Pomalidomide 4 mg was taken orally once daily from day 1 to day 21 of each 28-day cycle. Dexamethasone orally 40 mg (20 mg for patients ≥75 years of age) was given on days 1, 8, 15, and 22 of each 28-day cycle. A total of 531 patients were randomized in a 1:1 ratio to receive either SARCLISA ESCENA 1,400 mg fixed dose as subcutaneous administration with OBDS device (SARCLISA ESCENA-Pd arm, 263 patients) or intravenous isatuximab-irfc as a 10 mg/kg intravenous infusion (intravenous isatuximab-irfc-Pd arm, 268 patients), in combination with pomalidomide and dexamethasone.

The median patient age was 66 years (range 31–86), 18% of patients were ≥75 years; 69% of patients were White, 21% Asian, and 4.1% Black or African American. The International Staging System (ISS) stage at study entry was I in 59%, II in 27% and III in 12% of patients. Overall, 21% of patients had high-risk chromosomal abnormalities at study entry; del(17p), t(4;14), t(14;16), and chromosomal 1q21 abnormality.

The median weight was 72 kg (range: 36 to 161), with 32% of patients with a weight ≤65 kg, 44% with a weight >65 kg to ≤85 kg, and 24% with a weight >85 kg. The median number of prior lines of therapy was 2 (range 1–8) and 30% of patients had received 1 prior line of therapy. All patients except 1 received a prior proteasome inhibitor and prior lenalidomide, and 56% of patients received prior stem cell transplantation.

Patients were previously exposed to daratumumab, in 14% of patients in SARCLISA ESCENA-Pd arm vs 11% in intravenous isatuximab-irfc-Pd arm. The majority of patients (84%) were refractory to lenalidomide, 50% to a proteasome inhibitor, and 44% to both an immunomodulator and a proteasome inhibitor. The major efficacy measures were ORR as assessed by an Independent Review Committee, based on central laboratory data for M-protein and central radiologic imaging review using the International Myeloma Working Group (IMWG) criteria and the pharmacokinetic endpoint of C trough at steady state (corresponding to predose at Cycle 6 Day 1) [see Clinical Pharmacology (12.3) ].

The results show that SARCLISA ESCENA 1,400 mg administered subcutaneously in combination with Pd is non-inferior to intravenous isatuximab-irfc 10 mg/kg administered intravenously in combination with Pd in terms of ORR and C trough at steady state [see Clinical Pharmacology (12.3) ]. Efficacy results are presented in Table 9. Table 9 Cutoff date: 06 Nov 2024.

Median follow-up time: 12 months. : Efficacy of SARCLISA ESCENA-Pd versus Intravenous Isatuximab-irfc-Pd in the Treatment of Multiple Myeloma (IRAKLIA) SARCLISA ESCENA-Pd (N=263) Intravenous isatuximab-irfc-Pd (N=268) Randomization was stratified on body weight (<65 kg, >65–<85 kg, >85 kg), myeloma isotype (IgG versus non-IgG), and the number of prior lines of therapy (1–2 versus ≥3), by IRT. ORR (sCR, CR, VGPR or PR) n (%) Evaluated by the Independent Review Committee (IRC) using the IMWG response criter… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 27 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and genotoxicity studies have not been conducted with isatuximab-irfc. Fertility studies have not been conducted with isatuximab-irfc.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 24 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and genotoxicity studies have not been conducted with isatuximab-irfc. Fertility studies have not been conducted with isatuximab-irfc.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION SARCLISA ESCENA™ (sar-cli-sa es-SEEN-ah) (isatuximab-irfc) injection, for subcutaneous use This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 7/2026 SARCLISA ESCENA is used with two or three other medicines called pomalidomide, dexamethasone, carfilzomib, bortezomib, or lenalidomide.

You should also read the Medication Guide that comes with pomalidomide and lenalidomide. You can ask your healthcare provider or pharmacist for information about carfilzomib, bortezomib and dexamethasone. What is SARCLISA ESCENA?

SARCLISA ESCENA is a prescription medicine used in combination with: the medicines pomalidomide and dexamethasone, to treat adults who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor to treat multiple myeloma. the medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment, and they did not work or are no longer working. the medicines bortezomib, lenalidomide, and dexamethasone, to treat adults with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).

It is not known if SARCLISA ESCENA is safe and effective in children. Do not receive SARCLISA ESCENA if you have a severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA ESCENA. See the end of this leaflet for complete list of ingredients in SARCLISA ESCENA.

Before you receive SARCLISA ESCENA, tell your healthcare provider about all of your medical conditions, including if you: have an infection. have heart problems, if your healthcare provider prescribes SARCLISA ESCENA in combination with carfilzomib and dexamethasone for you. have had shingles (herpes zoster). are pregnant or plan to become pregnant. SARCLISA ESCENA can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will check for pregnancy before you start treatment with SARCLISA ESCENA.

Use an effective birth control (contraception) during treatment and for 7 months after your last dose of SARCLISA ESCENA. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA ESCENA.

Females and Males: Before receiving SARCLISA ESCENA in combination with either pomalidomide or lenalidomide, females and males must agree to the instructions in the pomalidomide or lenalidomide REMS programs. The pomalidomide and lenalidomide REMS programs have specific requirements about birth control, pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare provider to learn more about pomalidomide or lenalidomide. are breastfeeding or plan to breastfeed.

It is not known if SARCLISA ESCENA passes into your breast milk. Do not breastfeed during treatment with SARCLISA ESCENA and for 7 months after your last dose. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive SARCLISA ESCENA? SARCLISA ESCENA will be given to you by your healthcare provider as an injection under the skin (subcutaneous injection), in the stomach area (abdomen). Your healthcare provider will either use the CirCLIQ™ On-Body Injector or a syringe to inject SARCLISA ESCENA.

The injection time is usually 20 minutes with CirCLIQ and over about 6 minutes with a syringe. Your healthcare provider will rotate the injection site for each injection, including for other medicines. SARCLISA ESCENA in combination with pomalidomide and dexamethasone, or SARCLISA ESCENA in combination with carfilzomib and dexamethasone is given in treatment cycles of 28 days (4 weeks).

Cycle 1 (28-day cycle), SARCLISA ESCENA is given weekly. Cycle 2 and beyo… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Healthcare Provider INSTRUCTIONS FOR USE CirCLIQ™ On-Body Delivery System for use with SARCLISA ESCENA™ [sar-cli-sa es-SEEN-ah] (isatuximab-irfc) injection, for subcutaneous use Single-use CirCLIQ™ On-Body Delivery System Rx only This Instructions for Use contains information on how to use the CirCLIQ On-Body Delivery System to inject SARCLISA ESCENA. Read this Instructions for Use carefully before using the SARCLISA ESCENA vial and CirCLIQ On-Body Delivery System (OBDS). Important Information You Need to Know Before Injecting SARCLISA ESCENA.

See United States Prescribing Information (USPI) for information on SARCLISA ESCENA. The CirCLIQ OBDS contains one 10 mL single-use On-Body Injector and one Filling Base. Device must be filled prior to use.

The CirCLIQ OBDS is intended for abdominal subcutaneous injection of SARCLISA ESCENA single dose by a healthcare provider in adult patients. SARCLISA ESCENA is indicated for the treatment of adult patients with multiple myeloma. The SARCLISA ESCENA vial is not included in the CirCLIQ OBDS packaging.

For abdominal subcutaneous injection only. Administer directly into fatty layer under skin. Only use the CirCLIQ OBDS with SARCLISA ESCENA.

The CirCLIQ OBDS should not be used with any other medicines. Do not use the CirCLIQ OBDS if the expiration date has passed or its packaging was previously opened. Do not use the CirCLIQ OBDS components if they have been dropped on a hard surface because they could be damaged.

Start again with a new CirCLIQ OBDS. Do not use the CirCLIQ OBDS if the wearer has an acrylic allergy. The CirCLIQ On-Body Injector adhesive contains acrylic.

Use the CirCLIQ On-Body Injector as soon as possible after filling it with SARCLISA ESCENA. The injection should be completed within 4 hours once the vial is punctured. Do not attempt to reapply CirCLIQ On-Body Injector once attached to the abdomen.

Storing CirCLIQ OBDS Keep CirCLIQ OBDS away from children of 3 years and younger. Contains small parts. Store and transport CirCLIQ OBDS in its unopened plastic packaging inside of the original carton.

Store CirCLIQ OBDS in a clean, dry area away from heat and sunlight at 36°F to 86°F (2°C to 30°C). Use CirCLIQ OBDS where the temperature is 64°F to 82°F (18°C to 28°C). Storing SARCLISA ESCENA vial Store SARCLISA ESCENA vial in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until 20 minutes prior to use.

Do not freeze. Do not shake. Unpunctured vials may be stored at ambient temperature 64°F to 82°F (18°C to 28°C) for a single period of up to 24 hours.

Once the vial has been taken out of the refrigerator, it must not be returned to the refrigerator. Parts of the CirCLIQ OBDS (Filling Base and Wearable On-Body Injector) and SARCLISA ESCENA vial: For single use only Vial (not included in OBDS packaging) See SARCLISA ESCENA USPI for information on SARCLISA ESCENA. Part 1 – Getting ready to inject SARCLISA ESCENA (vial packaged separately from OBDS) 1 Get and inspect vial and CirCLIQ OBDS a) Take SARCLISA ESCENA vial out of the refrigerator.

Do not shake SARCLISA ESCENA vial. b) Allow the vial and OBDS to come to ambient temperature 64°F to 82°F (18°C to 28°C) for 20 minutes prior to use. c) Check SARCLISA ESCENA vial label to make sure it is the correct medication. The label should say : "SARCLISA ESCENA for subcutaneous use". Vial cap should be green.

Do not use SARCLISA ESCENA vial if the expiration date has passed. The medicine in SARCLISA ESCENA vial should be clear to slightly opalescent, colorless to slightly yellow. The solution may contain a few translucent to white particles. d) Check CirCLIQ OBDS.

Do not use CirCLIQ OBDS if the expiration date has passed or its packaging was previously opened. 2 Gather supplies Place the following on a flat clean surface: Vial filled with 1,400 mg dose of SARCLISA ESCENA (packaged separately) CirCLIQ OBDS in packaging Two alcohol wipes (not included in carton) Single-use gloves (not included in car… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 56 words ▾

PRINCIPAL DISPLAY PANEL - 140 mg/mL Vial Carton NDC 0024-0674-01 Rx only SARCLISA ESCENA™ (isatuximab-irfc) Injection 1,400 mg/10 mL (140 mg/mL) For subcutaneous use by healthcare providers only. Administer subcutaneously to the abdomen with CirCLIQ™ On-Body Injector OR syringe injection One single-dose vial Discard unused portion 962791 sanofi PRINCIPAL DISPLAY PANEL - 140 mg/mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sarclisa (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sarclisa. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.01M
Claims incl. refills
234
Beneficiaries
86
Spend / beneficiary
$35,047.88
Spend / claim
$12,880.85
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🛡
This drug has a REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It may require enrollment, counseling, or monitoring to manage a serious risk. See the boxed warning & full label below, and REMS@FDA ↗.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sanofi-Aventis U.S. LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sanofi-Aventis U.S. LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00024-0656-01 · Sanofi-Aventis 00024-1171-90 · Sanofi-Aventis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.