Idecabtagene Vicleucel Injection
Idecabtagene vicleucel (Abecma) is a one-time, personalized CAR T cell therapy given by IV infusion to adults with multiple myeloma that has come back or stopped responding after several earlier treatments.
🧬 Where this information comes from
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set 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 →
Abecma (idecabtagene vicleucel) is a one-time CAR T cell therapy for adults whose multiple myeloma has returned or stopped responding after several earlier treatments, built from their own T cells (immune cells) modified to find and kill myeloma cells carrying the protein BCMA; it is a specialist option on the U.S. market since about 2021, with no generic. It is a demanding treatment, and most people get cytokine release syndrome (CRS), an immune flare with fever, chills and low blood pressure. Its boxed warning covers possibly fatal CRS, serious nerve and brain effects, HLH/MAS (a runaway immune reaction), lasting low blood counts and later blood cancers, so report fever, confusion or bleeding at once.
Clinical pearls
- Avoid preventive steroids such as dexamethasone before the infusion, since they may blunt how well Abecma works.
- Stay near the treatment center for at least one week afterward, and do not drive for at least one week.
- Some HIV tests can read falsely positive after Abecma, so tell anyone ordering one that you had this therapy.
- Tell your team about any unresolved lung, heart or low blood pressure problems left over from earlier chemotherapy.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Abecma can cause life-threatening or fatal reactions, so it is given only where these can be treated quickly.
- Cytokine release syndrome (CRS): a strong immune reaction with fever, low blood pressure, and breathing trouble. It is treated with tocilizumab and sometimes steroids.
- Neurologic problems: these can be severe and may happen with or without CRS.
- HLH/MAS: a rare, dangerous overactive immune reaction.
- Prolonged low blood counts: these can cause bleeding and infection.
- Secondary cancers: T cell cancers have occurred after similar therapies.
Abecma should not be given to people with active infection or inflammatory disorders.
Patient Information Guide A plain-language walkthrough of Idecabtagene Vicleucel Injection, written from its FDA label.
What Idecabtagene Vicleucel Injection Is Used For
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Idecabtagene vicleucel is a CAR T cell therapy for multiple myeloma.
- Abecma (intravenous) treats adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
How Idecabtagene Vicleucel Injection Works
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Abecma is made from your own T cells, which are modified to carry a receptor that targets BCMA. BCMA is found on normal and cancerous plasma cells. When the modified cells meet BCMA, they multiply, release cytokines, and kill cells that carry it.
Idecabtagene Vicleucel Injection Dosage
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Abecma is a single-dose IV infusion made from your own cells. It is given at a treatment center after several days of lymphodepleting chemotherapy and premedication with acetaminophen and an antihistamine.
- The dose is based on the number of CAR-positive T cells.
- Your team may delay infusion up to seven days if you have an active infection or unresolved serious side effects.
- Missed-dose guidance does not apply, since it is a one-time treatment.
Dosing details from the FDA-approved label
From the Idecabtagene Vicleucel 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.
- Adult patients (ABECMA dose; autologous use only, for intravenous use only)
- The recommended dose range is 300 to 510 × 10 6 CAR-positive T cells, provided as a single dose for infusion in one or more infusion bags
- Lymphodepleting chemotherapy before infusion: cyclophosphamide 300 mg/m 2 intravenously (IV) and fludarabine 30 mg/m 2 IV for three days
- Administer ABECMA two days after completion of lymphodepleting chemotherapy
- Premed
- See the prescribing information of cyclophosphamide and fludarabine for dose adjustment in renal impairment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. • Do NOT use a leukodepleting filter. ( 2.2 ) • Administer a lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine before infusion of ABECMA. ( 2.2 ) • Confirm the patient's identity prior to infusion. ( 2.2 ) • Premedicate with acetaminophen and an H 1 -antihistamine. ( 2.2 ) • Avoid prophylactic use of dexamethasone or other systemic corticosteroids. ( 2.2 ) • Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.2 ) • Dosing of ABECMA is based on the number of chimeric antigen receptor (CAR)-positive T cells. ( 2.1 ) • The recommended dose range is 300 to 510 × 10 6 CAR-positive T cells. ( 2.1 ) 2.1 Dose For autologous use only. For intravenous use only. ABECMA is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags. The recommended dose range is 300 to 510 × 10 6 CAR-positive T cells. See the accompanying Release for Infusion Certificate (RFI Certificate) for additional information pertaining to dose [see How Supplied/Storage and Handling (16) ] . 2.2 Administration ABECMA is for autologous use only. The patient's identity must match the patient identifiers on the ABECMA cassette(s) and infusion bag(s). Do not infuse ABECMA if the information on the patient-specific label(s) does not match the intended patient. Preparing Patient for ABECMA Infusion Confirm the availability of ABECMA prior to starting the lymphodepleting chemotherapy regimen. Pretreatment Administer the lymphodepleting chemotherapy regimen: cyclophosphamide 300 mg/m 2 intravenously (IV) and fludarabine 30 mg/m 2 IV for three days. See the prescribing information of cyclophosphamide and fludarabine for information on dose adjustment in renal impairment. Administer ABECMA two days after completion of lymphodepleting chemotherapy. Delay the infusion of ABECMA up to seven days if a patient has any of the following conditions: • unresolved serious adverse events (especially pulmonary events, cardiac events, or hypotension), including those after preceding chemotherapies. • active infections or inflammatory disorders [see Warnings and Precautions (5.6) ] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Idecabtagene Vicleucel Injection Side Effects
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The most common side effects include:
Common side effects
- Fever (pyrexia)
- Cytokine release syndrome (CRS)
- Low antibody levels (hypogammaglobulinemia)
- Infections, including upper respiratory infections
- Muscle and bone pain
- Fatigue
- Fever with low white blood cells (febrile neutropenia)
- Low blood pressure, fast heartbeat, nausea, diarrhea, headache, chills
- Encephalopathy (brain dysfunction), swelling, and shortness of breath
When to get medical help
- Seek immediate medical attention for signs of cytokine release syndrome, such as fever, chills, low blood pressure, fast heartbeat, or trouble breathing.
- Seek immediate medical attention for neurologic symptoms such as confusion, severe headache, dizziness, delirium, or tremor.
- Report any signs of infection, such as fever, right away.
- Report bleeding, or new bruising, which can come from prolonged low blood counts.
- Seek emergency care for allergic reactions during or after infusion, including anaphylaxis.
- Tell your doctor if you develop any new cancer, including T cell cancers, after treatment.
Lab results often show low white cells, platelets, and hemoglobin. Call your team right away for fever, confusion, trouble breathing, bleeding, or signs of infection.
Idecabtagene Vicleucel Injection Warnings and Precautions
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- CRS can be fatal. It occurred in 89% of trial patients, usually starting within a day or so.
- Neurologic toxicities occurred in about 40% and can include encephalopathy, headache, and tremor.
- HLH/MAS occurred in 2.9% and can be fatal.
- Infections were common and sometimes fatal, including CMV and hepatitis B reactivation.
- Prolonged low blood counts need blood count monitoring.
- Low antibody levels may require immunoglobulin replacement.
- Allergic reactions, including anaphylaxis, may be linked to DMSO in the product.
- Secondary cancers, including T cell cancers, have occurred.
- Early death was more frequent in the Abecma group in one trial.
Idecabtagene Vicleucel Injection Interactions
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Few interactions are described, but two matter.
- Preventive steroids such as dexamethasone should be avoided before infusion, because they may interfere with Abecma.
- HIV nucleic acid tests may be falsely positive after treatment, because of shared genetic material with the manufacturing virus.
Interactions listed in the FDA-approved label
From the Idecabtagene Vicleucel Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- HIV nucleic acid tests (drug/laboratory test interaction): HIV and the lentivirus used to make ABECMA have limited, short spans of identical genetic material (RNA), so some commercial HIV nucleic acid tests may yield false-positive results in patients who have received ABECMA.
Read the label’s full interactions text
7 DRUG INTERACTIONS Drug/Laboratory Test Interactions HIV and the lentivirus used to make ABECMA have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received ABECMA.
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.
Before Taking Idecabtagene Vicleucel Injection
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- Abecma is not given during active infection or inflammatory disorders.
- It is not recommended during pregnancy, and a pregnancy test is needed first.
- Breastfeeding should be discussed with your doctor.
- It has not been established as safe or effective in children.
- Older adults had similar effectiveness, though more Grade 3 neurotoxicity occurred in those 65 and older in one study.
- Screening for CMV, hepatitis B and C, and HIV happens before cell collection.
What Idecabtagene Vicleucel Injection Does in the Body
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After infusion, levels of cytokines and other immune signals peak within 14 days and return to baseline within a month. Tumor markers, including soluble BCMA and bone marrow CD138+ cells, dropped quickly within the first month. Some patients also had minimal residual disease (MRD) negative responses.
How Your Body Processes Idecabtagene Vicleucel Injection
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After infusion, the CAR T cells multiply rapidly, peaking in the blood at a median of 11 days, then decline. They can stay in the blood for up to one year. Higher cell levels were linked with better tumor response. Age, sex, race, and ethnicity did not significantly affect expansion. Liver and kidney impairment studies were not done.
How to Store Idecabtagene Vicleucel Injection
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Store ABECMA frozen in the vapor phase of liquid nitrogen (less than or equal to minus 130°C).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Idecabtagene Vicleucel Injection: Pharmacist Answers to Common Questions
Quick, plain-English answers to the questions patients ask most about Idecabtagene Vicleucel Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Abecma used for?
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How is Abecma given?
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What side effects should I expect, and when should I call?
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Can I drive after Abecma?
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Is Abecma safe during pregnancy or breastfeeding?
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Will Abecma affect my HIV test results?
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When was Idecabtagene Vicleucel Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More About Idecabtagene Vicleucel Injection on HelloPharmacist
Idecabtagene Vicleucel Injection Forms and Strengths (How It Comes)
Idecabtagene Vicleucel 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 Idecabtagene Vicleucel Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Abecma is used for adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy.
- Abecma is for autologous use only, meaning it is made from your own cells, and is given by intravenous infusion.
- Abecma is given about two days after lymphodepleting chemotherapy, with acetaminophen and an antihistamine beforehand.
- Abecma must be infused within one hour of starting to thaw and without a leukodepleting filter.
- After Abecma infusion, stay near a healthcare facility and avoid driving for at least one week.
Idecabtagene Vicleucel Injection on the U.S. Market: Products, Makers and Brands
How Idecabtagene Vicleucel 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 1 Idecabtagene Vicleucel Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2021. Brand names on the directory include Abecma; the rest are generics.
Compare Idecabtagene Vicleucel Injection Products
A representative set of FDA-listed product records for Idecabtagene Vicleucel 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 | ||||
| IDECABTAGENE VICLEUCEL 300000000 1 | Intravenous | Celgene Corporation | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Idecabtagene Vicleucel Injection NDCs →
Idecabtagene Vicleucel Injection Side Effects Reported to the 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 Idecabtagene Vicleucel 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 Idecabtagene Vicleucel 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.
Idecabtagene Vicleucel Injection FDA Approval History
How Idecabtagene Vicleucel Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Idecabtagene Vicleucel 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 Idecabtagene Vicleucel recalls since July 2021.
✅No Idecabtagene Vicleucel recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2536430 1 dose form · 3 strengths
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Dose form (SCDF) Injection RxCUI 2536433In current FDA listingsClinical drug / strength (SCD) 30 ML idecabtagene vicleucel 17000000 CELLS/MLRxCUI 253643470 ML idecabtagene vicleucel 7285714 CELLS/MLRxCUI 2536443100 ML idecabtagene vicleucel 5100000 CELLS/MLRxCUI 2536449
Look up RxCUI 2536430 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Idecabtagene Vicleucel Injection Supply and Shortage Status
Whether Idecabtagene Vicleucel 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.
Idecabtagene Vicleucel Injection Brand Names
Idecabtagene Vicleucel Injection is sold under one brand name in the FDA directory — Abecma. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who Makes Idecabtagene Vicleucel Injection: Manufacturers and Labelers
One company lists Idecabtagene Vicleucel Injection products with the FDA. By number of product records, the largest are Celgene Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sources for This Idecabtagene Vicleucel 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.
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. Celgene Corporation 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 →