Ciltacabtagene Autoleucel Injection
Ciltacabtagene autoleucel is a personalized CAR-T cell therapy used to treat relapsed or refractory multiple myeloma in adults who have already received certain prior treatments.
🧬 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 ▾
Carvykti carries an FDA Boxed Warning — the most serious type of safety warning — for several potentially fatal reactions:
- Cytokine Release Syndrome (CRS): A powerful immune reaction that can be life-threatening. Signs include high fever, low blood pressure, and difficulty breathing. Carvykti must not be given to patients with active infections or inflammatory conditions.
- Serious Neurological Reactions (ICANS & others): Brain and nerve problems — including confusion, speech problems, Parkinson's-like symptoms, and Guillain-Barré syndrome — can be fatal. These can occur before, during, or after CRS.
- HLH/MAS: A life-threatening immune overactivation involving multiple organ systems, which can occur alongside CRS or neurological reactions.
- Prolonged Low Blood Cell Counts (Cytopenias): Dangerously low counts that increase risk of serious bleeding and infection; some patients have needed stem cell transplants to recover.
- Severe Bowel Inflammation (IEC-EC): Serious, potentially fatal gut inflammation can develop after treatment.
- Secondary Blood Cancers: New blood cancers — including myelodysplastic syndrome, acute myeloid leukemia, and T-cell malignancies — have been reported after treatment with Carvykti and similar therapies.
Watch for fever, confusion, weakness, difficulty breathing, or unusual bleeding and seek immediate medical care if these occur.
📖 Ciltacabtagene Autoleucel Injection: Patient Information Guide
A plain-language walkthrough of Ciltacabtagene Autoleucel 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▾
Ciltacabtagene autoleucel is a CAR-T cell immunotherapy approved for the following use:
- Carvykti (intravenous injection) is indicated for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent, and whose disease is refractory (no longer responding) to lenalidomide.
⚙️How it works▾
Carvykti works by harnessing and re-engineering your own immune system. Doctors collect your T cells (a type of immune cell) and genetically modify them in a lab to carry a special receptor called a CAR — short for chimeric antigen receptor. This CAR is programmed to recognize a protein called BCMA (B-cell maturation antigen), which is found on the surface of multiple myeloma cancer cells. Once the modified cells are infused back into your body, they attach to BCMA on the cancer cells, activate, multiply, and destroy those cells. The therapy uses two BCMA-targeting antibody fragments on each CAR for stronger binding, plus internal signals that help the T cells activate and expand robustly.
💊How it's taken▾
Carvykti is administered as a single, one-time intravenous infusion — it is not a pill or a repeated injection. Before receiving Carvykti, you will undergo a short course of chemotherapy (cyclophosphamide and fludarabine for 3 days) to prepare your immune system; Carvykti is then infused 2 to 4 days later. The entire infusion must be completed within 2.5 hours. After the infusion, you must be monitored at the treatment center or nearby for at least 2 weeks, and you should not drive during that period. Your care team will set and coordinate all scheduling.
🤒Side effects — in detail▾
Because Carvykti activates the immune system powerfully, a range of side effects are possible:
- Fever (very common)
- Low blood pressure (hypotension)
- Fatigue
- Nausea, diarrhea, vomiting, or constipation
- Cough or shortness of breath
- Headache or dizziness
- Muscle or bone pain
- Low antibody levels (hypogammaglobulinemia), raising infection risk
- Severely low blood cell counts (lymphopenia, neutropenia, thrombocytopenia, anemia) — common at Grade 3–4 severity
Serious reactions — including cytokine release syndrome, neurological problems, dangerous immune overactivation (HLH/MAS), severe bowel inflammation, and secondary blood cancers — require immediate medical attention. These are monitored closely by your care team but you should know the warning signs.
⚠️Warnings & precautions▾
- Cytokine Release Syndrome (CRS): Occurred in 84% of patients in clinical trials. Can be life-threatening — causes fever, low blood pressure, and breathing problems. Patients are monitored daily for at least 7 days after infusion.
- Serious Neurological Reactions: Include ICANS (confusion, difficulty speaking), Parkinson's-like symptoms, Guillain-Barré syndrome, peripheral neuropathy, and cranial nerve palsies. Some neurological effects can be delayed weeks to months and may be long-lasting.
- HLH/MAS (Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome): A rare but life-threatening immune overreaction that can cause organ failure and bleeding. Occurred in 1% of patients.
- Prolonged Low Blood Cell Counts: Occurred in 62% of patients at Grade 3 or higher. Increases risk of serious infection and bleeding; some patients needed stem cell transplants to recover.
- Immune-Related Bowel Inflammation (IEC-EC): Can cause severe, prolonged diarrhea months after infusion; potentially fatal.
- Secondary Blood Cancers: New blood cancers have been reported after Carvykti and similar therapies; contact the manufacturer if this occurs.
- Increased Early Mortality: In one clinical trial (CARTITUDE-4), there were numerically more early deaths in the Carvykti arm than in the control arm, many from infection.
🔀What it interacts with▾
Carvykti has limited traditional drug interactions because it is a living cell therapy, but there are important points to be aware of:
- HIV nucleic acid tests (NATs): The lentiviral vector used to make Carvykti shares some genetic material with HIV. Some commercial HIV blood tests may return a false-positive result — always inform any lab or provider that you have received Carvykti.
- Systemic corticosteroids (e.g., prednisone): Routine preventive use before infusion should be avoided because they may reduce how well Carvykti works. Corticosteroids are used only therapeutically for serious side effects like CRS or ICANS.
- Active infections or inflammatory conditions: Carvykti must not be given while these are present — they must be resolved before the infusion can proceed.
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: Carvykti must not be given until active infections or inflammatory conditions are resolved.
- History of Parkinson's disease or neurodegenerative disorders: Patients with these conditions were excluded from clinical trials — discuss with your doctor.
- CNS involvement from myeloma: Patients with known brain or spinal cord involvement by myeloma were excluded from trials.
- Pregnancy: Carvykti is not recommended during pregnancy. The modified cells could potentially cross the placenta and harm the fetus. Confirm you are not pregnant before starting, and use effective contraception.
- Breastfeeding: It is not known whether Carvykti passes into breast milk. Discuss risks and benefits with your doctor.
- Contraception: Female patients of childbearing potential and male patients with partners of childbearing potential should use effective contraception for at least one year after the infusion.
- Children: Safety and effectiveness in patients under 18 years of age have not been established.
- Older adults (65+): Neurological side effects occurred more frequently in patients 65 and older across clinical trials — closer monitoring is warranted.
- Prior stem cell transplant: Inform your care team; lymphodepleting chemotherapy may need to be delayed if graft-versus-host disease is active.
📡Pharmacodynamics — effects in the body▾
After a single infusion of Carvykti, the re-engineered CAR-T cells expand in the body, and this expansion coincides with measurable drops in markers of multiple myeloma — including soluble BCMA, M-protein, and free light chains in the blood. Immune signaling molecules (cytokines such as IL-6, IL-10, IFN-γ, and IL-2 receptor alpha) rise sharply in the first 1–2 weeks after infusion, reflecting strong immune activation, and generally return to baseline levels within 2–3 months.
🔬Pharmacokinetics — how your body processes it▾
After a single IV infusion, Carvykti's CAR-T cells go through an initial expansion phase — peaking around 12–13 days — followed by a rapid decline and then a slower, prolonged persistence phase. The median time for detectable CAR-T cell levels in the blood to return to pre-infusion baseline was approximately 100–109 days, though this varied widely between patients. Carvykti also distributes from the bloodstream into the bone marrow, where it can be detected. Patients with higher CAR-T cell expansion tended to have higher rates of CRS. Standard characteristics like age, sex, body weight, race, or mild kidney or liver impairment did not meaningfully affect how Carvykti expanded in the body.
📦How to store it▾
Store and transport below -120 °C, e. in the vapor phase of liquid nitrogen. Store CARVYKTI in the original packaging containing the cassette protecting the infusion bag.
📄 Written from Ciltacabtagene Autoleucel 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 Ciltacabtagene Autoleucel Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Is Carvykti a chemo drug I'll take every day? ▾
What should I watch for after I get the infusion — and when should I go to the ER? ▾
Will I be able to drive myself home after the infusion? ▾
I've heard this can cause something that looks like Parkinson's disease — is that true? ▾
Can I get pregnant after receiving Carvykti? ▾
I recently got a blood test for HIV and it came back positive — could Carvykti be causing a false result? ▾
When was Ciltacabtagene Autoleucel Injection first available? ▾
Who makes Ciltacabtagene Autoleucel Injection? ▾
💬 Answers drafted from Ciltacabtagene Autoleucel 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 Ciltacabtagene Autoleucel Injection comes
Ciltacabtagene Autoleucel 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
- Carvykti is indicated to treat adults with relapsed or refractory multiple myeloma who have received at least one prior therapy including a proteasome inhibitor and an immunomodulatory agent and whose disease is refractory to lenalidomide
- Carvykti is given as a single intravenous (IV) infusion at a certified medical center after a lymphodepleting chemotherapy course
- Carvykti must be thawed just before use and the entire infusion must be completed within 2.5 hours at room temperature
- Carvykti is for autologous use only — the product is made from and must be given only to the same patient whose cells were collected; patient identity must be confirmed before infusion
- Do not use a leukocyte-depleting filter during Carvykti infusion; premedicate with acetaminophen and an antihistamine 30–60 minutes before infusion
📊 Ciltacabtagene Autoleucel Injection across the U.S. market
How Ciltacabtagene Autoleucel 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 Ciltacabtagene Autoleucel Injection products
A representative set of FDA-listed product records for Ciltacabtagene Autoleucel 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 | ||||
| 100000000 1 | Intravenous | Janssen Biotech, Inc | BLA | View NDC → |
| 100000000 1-Jan | Intravenous | Janssen Biotech, Inc | BLA | View NDC → |
| CILTACABTAGENE AUTOLEUCEL 100000000 1 | Intravenous | Janssen Biotech, Inc. × 3 listings | BLA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Ciltacabtagene Autoleucel 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 Ciltacabtagene Autoleucel 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 Ciltacabtagene Autoleucel 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 Ciltacabtagene Autoleucel 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 2594775 1 dose form · 2 strengths
-
Dose form (SCDF) Injection RxCUI 2594779In current FDA listingsClinical drug / strength (SCD) 30 ML ciltacabtagene autoleucel 3330000 CELLS/MLRxCUI 259478970 ML ciltacabtagene autoleucel 1430000 CELLS/MLRxCUI 2594780
Look up RxCUI 2594775 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 Ciltacabtagene Autoleucel 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
Ciltacabtagene Autoleucel 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. Janssen Biotech, Inc 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.