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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.

Brand name Carvykti
Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 →

✓No current FDA shortage listed · checked Oct 8, 2026
Ciltacabtagene Autoleucel Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Carvykti is a one-time CAR-T cell therapy, on the U.S. market since about 2022, for adults whose multiple myeloma has come back or stopped responding, including to lenalidomide; it reprograms your own T cells (immune cells) to recognize BCMA, a protein on myeloma cells, destroy them and multiply to keep fighting. It is given only at specialized centers, and most people get cytokine release syndrome, an immune surge causing fever and low blood pressure. Its boxed warning adds brain and nerve problems (confusion, Parkinson-like symptoms, sometimes months later), HLH/MAS (immune overactivation), prolonged low blood counts and secondary blood cancers, so get help immediately at any fever, confusion or trouble breathing.

Clinical pearls

  • Plan to stay near the treating center for at least two weeks after the infusion, and do not drive during that time.
  • Some commercial HIV blood tests can read falsely positive after Carvykti, so tell any lab or provider you received it.
  • Report any infection or inflammatory flare before the infusion, since active infection is a reason to delay treatment.
  • Severe or lasting diarrhea in the months after treatment can signal immune-related bowel inflammation, so call your care team promptly.
How we write & review this content — our editorial policy →
⚠️ 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.

Read the full warning on DailyMed →
Comes asInjection
Earliest FDA record2022
Companies listing it with the FDA1
FDA label last updatedJul 15, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Ciltacabtagene Autoleucel Injection, written from its FDA label.

What Ciltacabtagene Autoleucel Injection is used for

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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 Ciltacabtagene Autoleucel Injection works

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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.

Ciltacabtagene Autoleucel Injection dosage

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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.

Dosing details from the FDA-approved label

From the Ciltacabtagene Autoleucel 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.

  • Adults treated with CARVYKTI (autologous, single-dose intravenous infusion of CAR-positive viable T cells)
    • Recommended dose range is 0.5–1.0×10^6 CAR-positive viable T cells per kg of body weight, as a single infusion, given 2 to 4 days after completion of the lymphodepleting chemotherapy regimen
    • Maximum: 1×10^8 CAR-positive viable T cells per single infusion
    • Weight-based dosing per kg of body weight
  • Lymphodepleting chemotherapy (pretreatment before CARVYKTI infusion)
    • Cyclophosphamide 300 mg/m2 intravenously (IV) and fludarabine 30 mg/m2 IV daily for 3 days
    • See the cyclophosphamide and fludarabine prescribing information for dose adjustment in renal impairment
  • Premedication (all patients, 30–60 minutes prior to CARVYKTI infusion)
    • Oral or intravenous acetaminophen 650 to 1000 mg and oral or intravenous diphenhydramine 25 to 50 mg or equivalent
    • Avoid prophylactic use of systemic corticosteroids
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of CARVYKTI. ( 2.2 ) Do NOT use a leukodepleting filter. ( 2.2 ) Verify the patient's identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and an H1-antihistamine. ( 2.2 ) Avoid prophylactic use of systemic corticosteroids. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.2 ) Dosing of CARVYKTI is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. ( 2.1 ) Recommended dose range is 0.5–1.0×10 6 CAR-positive viable T cells per kg of body weight, with a maximum dose of 1×10 8 CAR-positive viable T cells per single-dose infusion. ( 2.1 ) 2.1 Dose CARVYKTI is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive viable T cells in one infusion bag. The recommended dose range is 0.5–1.0×10 6 CAR-positive viable T cells per kg of body weight, with a maximum dose of 1×10 8 CAR-positive viable T cells per single infusion. 2.2 Administration CARVYKTI is for autologous use only. For intravenous use only. The patient's identity must match the patient identifiers on the CARVYKTI cassette and infusion bag. Do not infuse CARVYKTI if the information on the patient-specific labels does not match the intended patient. Preparing the Patient for CARVYKTI Infusion Confirm availability of CARVYKTI 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 daily for 3 days. See the prescribing information of cyclophosphamide and fludarabine for information on dose adjustment in renal impairment. Lymphodepleting regimen must be delayed if a patient has serious adverse reactions from preceding bridging therapies (including clinically significant active infection, cardiac toxicity, and pulmonary toxicity) or active graft versus host disease in patient with prior allogeneic stem cell transplant. Consider repeating lymphodepleting regimen if CARVYKTI dosing is delayed by more than 14 days and patient has recovered from toxicity of the first lymphodepleting regimen.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ciltacabtagene Autoleucel Injection side effects

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Because Carvykti activates the immune system powerfully, a range of side effects are possible:

Common side effects

  • Fever (pyrexia)
  • Low blood pressure (hypotension)
  • Fatigue
  • Nausea, diarrhea, or vomiting
  • Cough or shortness of breath
  • Headache or dizziness
  • Muscle or bone pain
  • Low levels of protective antibodies (hypogammaglobulinemia)
  • Nausea, diarrhea, vomiting, or constipation
  • Severely low blood cell counts (lymphopenia, neutropenia, thrombocytopenia, anemia) — common at Grade 3–4 severity

When to get medical help

  • Get immediate medical help if you develop high fever, chills, difficulty breathing, or a rapid heartbeat — these can be signs of cytokine release syndrome (CRS), a potentially life-threatening immune reaction
  • Seek emergency care for confusion, difficulty speaking, seizures, tremors, or any sudden neurological changes — these may signal a serious brain or nerve reaction (ICANS or parkinsonism)
  • Call your doctor right away if you develop signs of serious infection such as fever, chills, or feeling very unwell — prolonged low white blood cell counts increase infection risk
  • Report any unusual bleeding, bruising, or signs of very low platelet or red blood cell counts (cytopenias)
  • Tell your doctor immediately if you develop severe or prolonged diarrhea in the months after treatment — this may signal immune-related bowel inflammation (IEC-EC)
  • Contact your care team if you develop weakness, numbness, facial drooping, or changes in vision or hearing — these may be signs of nerve problems such as Guillain-Barré syndrome or cranial nerve palsy
  • Inform your doctor of any new or unusual fatigue, bruising, or frequent infections that could signal a secondary blood cancer

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.

Ciltacabtagene Autoleucel Injection warnings and precautions

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  • 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.

Ciltacabtagene Autoleucel Injection interactions

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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.

Interactions listed in the FDA-approved label

From the Ciltacabtagene Autoleucel Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • HIV nucleic acid tests (NATs): HIV and the lentivirus used to make CARVYKTI share limited, short spans of identical genetic material (RNA), so some commercial HIV NATs may give false-positive results in patients who have received CARVYKTI.
Read the label’s full interactions text

7 DRUG INTERACTIONS HIV and the lentivirus used to make CARVYKTI have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid tests (NATs) may yield false-positive results in patients who have received CARVYKTI.

Read the full Drug Interactions section on DailyMed →

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.

Check Ciltacabtagene Autoleucel Injection against a supplement or herb →

Before taking Ciltacabtagene Autoleucel Injection

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  • 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.

What Ciltacabtagene Autoleucel Injection does in the body

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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.

How your body processes Ciltacabtagene Autoleucel Injection

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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 Ciltacabtagene Autoleucel Injection

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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 the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Ciltacabtagene Autoleucel Injection: pharmacist answers to common questions

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?

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No — Carvykti is nothing like a daily chemotherapy pill. It's a one-time infusion made specifically from your own T cells. The process involves collecting your cells, having them genetically modified in a lab over several weeks, and then receiving them back as a single IV infusion at your treatment center. After that infusion, you won't be taking Carvykti again.

What should I watch for after I get the infusion — and when should I go to the ER?

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The biggest thing to watch for in the first week or two is cytokine release syndrome (CRS) — signs include a high fever, chills, low blood pressure, or trouble breathing. You should also watch for any neurological changes: confusion, difficulty speaking, tremors, or weakness. If any of these happen, don't wait — go to the ER or call your care team immediately. You're required to stay near a medical facility for at least 2 weeks after the infusion for exactly this reason.

Will I be able to drive myself home after the infusion?

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No — you should not drive for at least 2 weeks after your infusion. The potential for neurological side effects like confusion, dizziness, or other brain-related reactions is real, and driving would not be safe during that window. Make sure you have someone available to help with transportation during your recovery period.

I've heard this can cause something that looks like Parkinson's disease — is that true?

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Yes, a small number of patients in clinical trials — about 3% — developed Parkinson's-like symptoms such as movement problems, cognitive changes, and personality changes after Carvykti. These symptoms tended to appear weeks to months after the infusion and were often long-lasting. It's an important risk to be aware of, and your care team will monitor you for it. If you notice any tremor, slowed movement, or personality changes, report them promptly.

Can I get pregnant after receiving Carvykti?

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Pregnancy after Carvykti should definitely be discussed with your doctor before you start treatment. Because the modified cells could potentially cross the placenta and harm a developing baby, Carvykti is not recommended during pregnancy. You'll be advised to use effective contraception — and in the clinical trials, patients were asked to continue contraception for at least a year after the infusion. A pregnancy test is done before treatment begins.

I recently got a blood test for HIV and it came back positive — could Carvykti be causing a false result?

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Yes, that's possible. Carvykti is made using a modified viral carrier (a lentiviral vector) that shares a small amount of genetic material with HIV. Some commercial HIV blood tests can mistakenly detect this as a positive HIV result. This does not mean you have HIV. Always let any lab or new provider know that you have received Carvykti so they can interpret your test results correctly.

When was Ciltacabtagene Autoleucel Injection first available?

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The earliest FDA record we hold for Ciltacabtagene Autoleucel Injection is from 2022: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ciltacabtagene Autoleucel Injection was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

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Detailed data & references for Ciltacabtagene Autoleucel Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ciltacabtagene Autoleucel Injection forms and strengths (how it 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ciltacabtagene Autoleucel Injection inactive ingredients by manufacturer.

Injection

Into a vein
Brands Carvykti
How this form is used
What it may be used for
  • 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
Important instructions
  • 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
Available strengths 3 strengths
100000000 1 100000000 1-Jan CILTACABTAGENE AUTOLEUCEL 100000000 1
5 FDA-listed product records ⓘ

Ciltacabtagene Autoleucel Injection on the U.S. market: products, makers and brands

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.

1 company lists 1 Ciltacabtagene Autoleucel Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2022. Brand names on the directory include Carvykti; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2022
Earliest FDA record ⓘ

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
CILTACABTAGENE AUTOLEUCEL 100000000 1 Intravenous Janssen Biotech, Inc. BLA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Ciltacabtagene Autoleucel Injection NDCs →

Ciltacabtagene Autoleucel 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 Ciltacabtagene Autoleucel recalls since July 2021.

✅No Ciltacabtagene Autoleucel recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 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.

Ingredient (IN) Ciltacabtagene Autoleucel Injection RxCUI 2594775 1 dose form · 2 strengths

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.

Ciltacabtagene Autoleucel Injection brand names

Ciltacabtagene Autoleucel Injection is sold under one brand name in the FDA directory — Carvykti. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Carvykti

Who makes Ciltacabtagene Autoleucel Injection: manufacturers and labelers

One company lists Ciltacabtagene Autoleucel Injection products with the FDA. By number of product records, the largest are Janssen Biotech, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Janssen Biotech, Inc. 1

Ciltacabtagene Autoleucel Injection drug class (RxNorm)

Ciltacabtagene Autoleucel Injection belongs to the Antineoplastic cell and gene therapy class.

Drug family (ATC) Antineoplastic cell and gene therapy

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.

Sources for this Ciltacabtagene Autoleucel 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 15, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ciltacabtagene Autoleucel Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ciltacabtagene Autoleucel Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Janssen Biotech, Inc
Linked label effective
Jul 15, 2026
Composite sections available
24
Linked SPL Set ID
7d040b91-3fb8-41db-ba7f-60a36f06e2c2
Linked SPL Document ID
49401d9c-3707-4a8e-9cfd-7e648bfe0f43
Open the linked representative label on DailyMed ↗

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. Janssen Biotech, Inc 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 →