Isatuximab-irfc Injection
Isatuximab-irfc injection is a targeted antibody therapy used to treat multiple myeloma (a cancer of plasma cells in bone marrow) in adults, available as intravenous and subcutaneous formulations.
🧬 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 →
📖 Isatuximab-irfc Injection: Patient Information Guide
A plain-language walkthrough of Isatuximab-irfc Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Isatuximab-irfc injection treats multiple myeloma — a cancer of plasma cells — in adults, always as part of a combination regimen.
- Sarclisa Escena (subcutaneous) and Sarclisa (intravenous): used with pomalidomide and dexamethasone in patients who have received at least 1 prior line of therapy that included lenalidomide and a proteasome inhibitor.
- Sarclisa Escena (subcutaneous) and Sarclisa (intravenous): used with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have had 1 to 3 prior treatment regimens.
- Sarclisa Escena (subcutaneous) and Sarclisa (intravenous): used with bortezomib, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
⚙️How it works▾
Isatuximab-irfc is a monoclonal antibody — a precision-engineered protein — that latches onto a protein called CD38 found abundantly on myeloma cancer cells. Once it binds to CD38, it sets off several cancer-killing actions: it signals the myeloma cell to self-destruct (apoptosis), activates immune cells to attack the cancer (including antibody-dependent cytotoxicity and phagocytosis), and engages the complement system — another immune defense. It also activates natural killer (NK) immune cells and dials down certain immune-suppressing T-regulatory cells that might otherwise protect the tumor.
When combined with pomalidomide, the cancer-cell killing and immune-activation effects of isatuximab-irfc are amplified beyond what either drug does alone, which is why it is always given as part of a combination regimen.
💊How it's taken▾
Isatuximab-irfc is always given by a healthcare professional — never self-administered at home. The dosing schedule depends on which combination regimen you are on and which product is being used.
- Sarclisa Escena (subcutaneous): typically given weekly during the first 28-day cycle, then every 2 weeks. In the bortezomib/lenalidomide/dexamethasone regimen, the schedule eventually shifts to once every 4 weeks from cycle 13 onward.
- Sarclisa (intravenous): given by IV infusion in a clinic on a similar schedule — weekly in cycle 1, then every 2 weeks.
- Treatment continues until the disease progresses or side effects make it necessary to stop.
- If a planned dose is missed, it should be given as soon as possible, with the schedule adjusted to maintain the proper interval between doses.
🤒Side effects — in detail▾
Isatuximab-irfc is associated with a range of side effects depending on which combination it is used with.
- Upper respiratory tract infections — very common across all combinations
- Pneumonia — common; can be serious
- Infusion- or injection-related reactions — fever, shortness of breath, chills
- Fatigue
- Diarrhea
- Low red blood cell count (decreased hemoglobin/anemia)
- Low white blood cell count (neutropenia) — raises infection risk
- Low platelet count — raises bleeding risk
- High blood pressure — particularly with carfilzomib combination
- Peripheral sensory neuropathy (numbness/tingling) — particularly with bortezomib combination
Serious reactions to report immediately include severe breathing difficulty, signs of infection (especially fever), or signs of very low blood counts such as unusual bruising or bleeding.
⚠️Warnings & precautions▾
- Administration reactions: Serious, potentially life-threatening systemic reactions can occur during or after dosing — especially early in treatment. Premedications are given before each dose to lower the risk, and a healthcare professional monitors you throughout. A grade 4 (life-threatening) reaction means the medicine must be stopped permanently.
- Serious and fatal infections: This medicine can significantly weaken your immune defenses. Pneumonia and other serious infections have caused deaths in clinical trials. Your doctor may prescribe preventive antibiotic or antiviral medicines.
- Neutropenia (very low white blood cell count): Blood counts must be checked regularly. Dose delays and growth-factor injections may be needed if counts fall too low.
- Second primary malignancies: A small risk of developing a different, new cancer exists — ongoing monitoring is part of your care.
- Fetal harm: This medicine can harm an unborn baby. Effective contraception is required during treatment and for 5 months after the last dose.
- Lab test interference: Isatuximab-irfc can falsely alter blood bank compatibility tests and the M-protein tests used to measure your myeloma response. Always alert any laboratory or blood bank that you are on this medicine.
🔀What it interacts with▾
Isatuximab-irfc does not have traditional drug-drug interactions listed on the label, but it does interfere with important laboratory tests that can affect your care.
- Blood bank serologic tests (indirect Coombs/crossmatch): Isatuximab-irfc can cause false-positive results in blood compatibility tests — this could complicate blood transfusions. Always tell any blood bank or hospital that you receive this medicine.
- M-protein monitoring tests (serum protein electrophoresis/immunofixation): The drug itself can show up on tests used to measure how well your myeloma is responding to treatment, potentially making it look like you haven't reached complete remission when you have. Special assays may be used to sort out the true result.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Severe allergy: Do not use if you have had a severe hypersensitivity reaction to isatuximab-irfc or any of its ingredients — this is a contraindication.
- Pregnancy: This medicine can cause fetal harm. If you could become pregnant, you must use effective contraception during treatment and for 5 months after the last dose. Pregnancy testing requirements also apply if you are taking pomalidomide or lenalidomide alongside this medicine.
- Breastfeeding: Do not breastfeed while on this medicine due to the potential for serious harm to the infant.
- Infants exposed in the womb: Babies born to mothers who received this medicine should not receive live vaccines until a hematology (blood) evaluation has been completed.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (75+): May be at higher risk for neutropenia and dose delays; monitored more closely in trials.
- Kidney disease: No dose adjustment is needed, including for patients on dialysis.
- Liver disease: No dose adjustment is recommended for mild liver impairment; the effect of moderate to severe liver impairment is not fully known.
📡Pharmacodynamics — effects in the body▾
In patients treated with isatuximab-irfc, the drug measurably lowers the levels of certain immune cells — particularly natural killer (NK) cells and B cells — in the bloodstream. This reflects its active engagement with the immune system as part of its cancer-fighting mechanism. Importantly, at up to twice the approved dose, isatuximab-irfc does not significantly affect the heart's electrical rhythm (QT interval). A clear relationship has been observed between higher drug exposure and better response rates and longer progression-free survival.
🔬Pharmacokinetics — how your body processes it▾
Isatuximab-irfc builds up in the body over time, reaching steady-state levels around 18 weeks into treatment. It is broken down by the body into small peptides through normal protein-processing pathways — not through the liver enzymes that process most small-molecule drugs. After the last dose, it takes approximately 2 months for the drug to be nearly completely (≥99%) cleared from the bloodstream. Factors such as age, sex, kidney function (including dialysis), and mild liver impairment do not meaningfully affect how the body handles this drug, so no dose adjustments are needed for these groups; body weight does affect clearance, which is why weight-based dosing is used.
📦How to store it▾
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 Isatuximab-irfc Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
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.
What exactly is isatuximab-irfc and what is it supposed to do for my myeloma? ▾
How will I receive this medicine, and will I have to stay in a clinic all day? ▾
What side effects should I expect, and which ones mean I should call someone right away? ▾
I've heard this medicine can affect my blood tests. What does that mean for me? ▾
Is it safe to get pregnant or breastfeed while I'm on this treatment? ▾
Does my age or kidney disease change how this medicine works in my body? ▾
Is Isatuximab-irfc Injection available over the counter? ▾
When was Isatuximab-irfc Injection first available? ▾
Who makes Isatuximab-irfc Injection? ▾
💬 Answers drafted from Isatuximab-irfc Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Isatuximab-irfc Injection 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.
Injection
How this form is used
- Sarclisa Escena (subcutaneous) is used with pomalidomide and dexamethasone for multiple myeloma after at least 1 prior therapy including lenalidomide and a proteasome inhibitor.
- Sarclisa Escena (subcutaneous) is used with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma after 1 to 3 prior therapies.
- Sarclisa Escena (subcutaneous) is used with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adults not eligible for a stem cell transplant.
- Sarclisa (intravenous) is approved for the same multiple myeloma indications, given by IV infusion in a clinical setting.
- Sarclisa Escena is for subcutaneous injection into the abdomen only — not given intravenously — and must be administered by a healthcare professional.
- Sarclisa Escena can be given using the CirCLIQ On-Body Delivery System (OBDS) or with a syringe and infusion set for manual administration; the method is chosen by your care team.
- Before each Sarclisa Escena dose, premedications (including dexamethasone, a leukotriene receptor antagonist during the first cycle, acetaminophen, and diphenhydramine) are given 15–60 minutes prior to reduce reaction risk.
- Sarclisa Escena injection sites in the abdomen should be rotated at least 1 inch from the previous site with each dose; do not inject into skin that is red, scarred, tender, or injured.
📊 Isatuximab-irfc Injection across the U.S. market
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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 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 | sanof-aventis U.S. LLC × 2 listings | BLA | View NDC → |
| 500 mg/25 mL | Intravenous | sanof-aventis U.S. LLC × 2 listings | BLA | View NDC → |
| 1400 mg/10 mL | — | Sanofi-Aventis Deutschland GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg/5 mL | Intravenous | Sanofi-Aventis U.S. LLC × 2 listings | 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 × 2 listings | BLA | View NDC → |
Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Isatuximab-irfc Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Isatuximab-irfc Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Isatuximab-irfc Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Isatuximab-irfc Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Isatuximab-irfc Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Isatuximab-irfc Injection belongs to the CD38-directed Cytolytic Antibody class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sanofi-Aventis U.S. LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.