Idecabtagene Vicleucel Injection
Idecabtagene vicleucel (Abecma) is a personalized CAR T cell therapy made from a patient's own immune cells, used to treat relapsed or refractory multiple myeloma in adults.
🧬 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 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Abecma carries a black box warning — the FDA's most serious safety alert — covering five major risks:
- Cytokine Release Syndrome (CRS): A powerful immune reaction that can be fatal. Symptoms include high fever, low blood pressure, and difficulty breathing. Abecma must not be given to patients with active infections or inflammatory conditions. Severe CRS requires immediate treatment with specific medications.
- Neurologic toxicities: Serious or life-threatening nerve and brain effects — including confusion, seizures, or loss of coordination — can occur during, after, or even without CRS. Patients must be monitored daily for at least a week.
- HLH/MAS (Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome): A rare but potentially fatal condition where the immune system damages the body's own organs, sometimes occurring alongside CRS or neurologic side effects.
- Prolonged low blood counts (cytopenias): Dangerously low levels of white blood cells or platelets can persist after treatment, leading to serious bleeding or infection. Some patients have needed stem cell transplants to recover.
- Secondary T cell malignancies: New T cell cancers have occurred in patients treated with CAR T cell therapies including Abecma. This risk, while rare, is serious and requires long-term monitoring.
📖 Idecabtagene Vicleucel Injection: Patient Information Guide
A plain-language walkthrough of Idecabtagene Vicleucel 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▾
Idecabtagene vicleucel (Abecma) is a CAR T cell immunotherapy approved for a specific group of adults with multiple myeloma.
- Abecma is indicated for adults with relapsed or refractory multiple myeloma — cancer that has returned or stopped responding to prior therapies — after at least two prior lines of treatment
- Those prior regimens must have included all three of the following: an immunomodulatory agent (such as lenalidomide or pomalidomide), a proteasome inhibitor (such as bortezomib or carfilzomib), and an anti-CD38 monoclonal antibody (such as daratumumab)
- Abecma is approved for adult patients only; safety and efficacy in patients under 18 have not been established
⚙️How it works▾
Abecma is a chimeric antigen receptor (CAR) T cell therapy. A patient's own T cells (a type of immune cell) are collected, then genetically engineered in a lab to display a special receptor — the CAR — on their surface. This CAR is designed to recognize and bind to a protein called BCMA (B-cell maturation antigen), which is found on the surface of normal and cancerous plasma cells in multiple myeloma. Once infused back into the patient, these engineered cells multiply, release immune-signaling proteins called cytokines, and directly kill BCMA-carrying cancer cells.
Because the therapy is made from each patient's own cells and targets a protein specific to plasma cells, it is highly personalized and targeted — but that same immune activation is also why serious side effects like cytokine release syndrome can occur.
💊How it's taken▾
Abecma is given as a single, one-time intravenous (IV) infusion at a specialized treatment center — it is not taken at home. Before the infusion, patients receive three days of lymphodepleting chemotherapy (cyclophosphamide and fludarabine given intravenously), and Abecma is infused about two days after that is complete. The dose is measured in CAR-positive T cells, determined individually for each patient.
- Patients are premedicated with acetaminophen and an antihistamine before infusion
- Systemic corticosteroids like dexamethasone should be avoided before infusion, as they may reduce the therapy's effectiveness
- After infusion, patients must remain near a healthcare facility and be monitored daily for at least one week
- Driving should be avoided for at least one week after infusion
🤒Side effects — in detail▾
Abecma commonly causes immune-related and blood count effects that are monitored closely by the care team.
- Fever (very common — in nearly 9 out of 10 patients as part of CRS)
- Low blood pressure (hypotension)
- Rapid heartbeat (tachycardia)
- Chills and fatigue
- Nausea, diarrhea, and headache
- Confusion or encephalopathy (altered brain function)
- Shortness of breath (dyspnea)
- Low white blood cell and platelet counts, which may raise infection and bleeding risk for weeks after treatment
Serious reactions — including life-threatening cytokine release syndrome, neurologic toxicity, dangerous immune overactivation (HLH/MAS), and severe infections — can occur and require immediate medical attention. Contact your care team immediately if any of these develop.
⚠️Warnings & precautions▾
- Cytokine Release Syndrome (CRS): Occurred in 89% of patients in clinical trials. Can range from fever and chills to life-threatening low blood pressure, organ failure, and death. Requires monitoring in a medical setting and may be treated with tocilizumab and/or corticosteroids.
- Neurologic toxicity: Occurred in 40% of patients. Symptoms include confusion, delirium, tremors, and in rare cases, cerebral edema or parkinsonism. Can occur at the same time as CRS or independently.
- HLH/MAS: A rare, potentially fatal immune overactivation affecting multiple organs. Occurred in about 3% of patients, typically within 10 days of infusion.
- Prolonged low blood counts: Low neutrophil and platelet counts lasting beyond one month occurred in roughly 40% of patients, increasing risk of bleeding and serious infection.
- Serious infections: Occurred in 61% of patients overall, including life-threatening bacterial, viral, and fungal infections. CMV and HBV reactivation have been reported.
- Low antibody levels (hypogammaglobulinemia): Can weaken the immune system long-term; immunoglobulin replacement therapy may be needed.
- Secondary T cell malignancies: Rare but serious new cancers have occurred after treatment with CAR T cell therapies including Abecma.
- Early death risk: In one clinical study, a higher proportion of patients died within nine months in the Abecma group compared to the standard treatment group — this was largely driven by deaths before infusion due to disease progression.
🔀What it interacts with▾
Abecma has a limited number of known drug and lab test interactions, but one is important to be aware of.
- HIV nucleic acid tests (lab tests): Because the lentiviral vector used to make Abecma shares limited genetic material with HIV, some commercial HIV tests may give a false-positive result. Always tell any provider ordering HIV testing that you have received Abecma.
- Corticosteroids (such as dexamethasone): Prophylactic (preventive) use of systemic corticosteroids before infusion should be avoided, as they may interfere with how well Abecma works — though corticosteroids may still be used to treat serious side effects after infusion if needed.
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▾
- Active infection or inflammation: Abecma must not be given to patients with active infections or inflammatory disorders — infusion should be delayed until these resolve
- Pregnancy: Abecma is not recommended during pregnancy. If the engineered cells cross the placenta, they could cause harm to the fetus, including plasma cell aplasia. Newborns of mothers treated with Abecma should have their immunoglobulin levels checked.
- Breastfeeding: It is unknown if Abecma is present in breast milk; discuss risks and benefits with your care team
- Women and men of reproductive potential: Pregnancy should be ruled out before starting treatment; contraception guidance from the lymphodepleting chemotherapy prescribing information should be followed
- Children (under 18): Safety and effectiveness have not been established
- Older adults (65 and older): Abecma has been used safely in this age group, but all Grade 3 neurologic toxicity cases in one study occurred in patients aged 65–74; closer monitoring is warranted
- CNS disease history: Patients requiring ongoing immunosuppression or with active CNS disease were excluded from clinical trials
- Screening before treatment: Patients should be screened for CMV, HBV, HCV, and HIV before their cells are collected for manufacturing
📡Pharmacodynamics — effects in the body▾
After Abecma is infused, the engineered CAR T cells activate and begin working quickly. Cytokines, chemokines, and other immune signals peak in the blood within 14 days of infusion and generally return to baseline within a month. Tumor markers — including a protein called soluble BCMA and cancer cells in the bone marrow — begin to drop within the first month, reflecting the therapy's anti-cancer activity. In clinical studies, patients who showed higher levels of Abecma expansion in the blood were significantly more likely to respond to treatment.
🔬Pharmacokinetics — how your body processes it▾
After the infusion, Abecma's CAR-positive T cells rapidly multiply (expand) in the body, reaching peak levels in peripheral blood at a median of 11 days post-infusion. After that peak, cell levels decline in a two-phase pattern but Abecma can continue to be detected in the blood for up to one year after infusion. Higher expansion of the cells in the body was associated with better tumor responses in clinical studies. Age, sex, race, and ethnicity did not significantly affect how well the cells expanded, though patients with lower body weight tended to have somewhat higher expansion levels.
📦How to store it▾
Store ABECMA frozen in the vapor phase of liquid nitrogen (less than or equal to minus 130°C).
📄 Written from Idecabtagene Vicleucel 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 Idecabtagene Vicleucel Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Abecma and how is it different from regular chemotherapy? ▾
What are the most important side effects I should know about? ▾
Will I be able to go home the same day as my infusion? ▾
Is this safe if I'm pregnant or planning to become pregnant? ▾
I had an HIV test recently — could Abecma affect the result? ▾
What happens with my immune system after treatment — am I more vulnerable to infections? ▾
When was Idecabtagene Vicleucel Injection first available? ▾
💬 Answers drafted from Idecabtagene Vicleucel 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 Idecabtagene Vicleucel Injection 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.
Injection
How this form is used
- Abecma is used to treat adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy that included specific drug classes
- Abecma is for autologous use only — it is made from the individual patient's own T cells and can only be given back to that same patient
- Abecma is given as a single intravenous (IV) infusion at a qualified medical center, approximately two days after completion of lymphodepleting chemotherapy
- Abecma must be thawed before infusion and administered within one hour of the start of the thaw process
- Patients must be premedicated with acetaminophen and an antihistamine before infusion; systemic corticosteroids such as dexamethasone should be avoided beforehand
- Abecma must not be filtered with a leukodepleting filter; central venous access is encouraged in patients with poor peripheral vein access
📊 Idecabtagene Vicleucel Injection across the U.S. market
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.
🔍 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 | ||||
| 300000000 1 | Intravenous | Celgene Corporation | BLA | View NDC → |
| 300000000 1-Jan | Intravenous | Celgene Corporation | BLA | View NDC → |
| IDECABTAGENE VICLEUCEL 300000000 1 | Intravenous | Celgene Corporation × 2 listings | BLA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Idecabtagene Vicleucel 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 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.
🏛️ The road to your pharmacy
How Idecabtagene Vicleucel 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.
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
-
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.
📦 Supply & 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Idecabtagene Vicleucel Injection belongs to the Antineoplastic cell and gene therapy 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 1 FDA-filed SPL label set 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. Celgene Corporation 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.