Pronunciation: car-vick-tee
Generic name: ciltacabtagene autoleucel
Dosage form: intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on July 28, 2025.

What is Carvykti?

Carvykti is a one-time infusion used to treat relapsed or refractory multiple myeloma (RRMM), starting as early as the first relapse.

Carvykti is a type of immunotherapy called BCMA-targeted CAR-T cell therapy. In this treatment, T cells (a type of immune cell) are collected and genetically modified to recognize and attack the BCMA protein on multiple myeloma cells. These modified T cells are then multiplied in a lab and returned to your body as a personalized infusion.

Carvykti (ciltacabtagene autoleucel) is used in adults with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.

Carvykti FDA approval was first granted on February 28, 2022, for certain adults with relapsed or refractory multiple myeloma. Then on April 5, 2024, the FDA expanded Carvykti’s approval to include patients experiencing their first multiple myeloma relapse, following new data from the Phase 3 CARTITUDE-4 study (NCT04181827) demonstrating 65.9% Carvykti patients had a stringent complete response.

Carvykti side effects

Common side effects of Carvykti may include:

• confusion, cough, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired;
• headache, dizziness;
• problems with speech;
• low blood cell counts;
• fever, chills, tiredness, or other signs of infection;
• decreased appetite, constipation, nausea or diarrhea; or
• pain in your joints or muscles.
  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Serious Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

A serious side effect of ciltacabtagene autoleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also, call your doctor at once if you have:

• confusion, loss of consciousness, seizures, problems with speech, reading or writing, depression;
• tingling and numbness of hands and feet, leg and arm weakness, facial numbness; or
  
  

Patients should be closely monitored for any adverse reactions. Contact a healthcare provider immediately if experiencing severe side effects.

These are not all of the possible side effects of Carvykti. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

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Warnings & precautions

• Avoid Carvykti if you have an active infection or inflammatory disorder.
• Do not receive live vaccines before or after treatment.
• Drowsiness & Cognitive Impairment: Refrain from driving or operating heavy machinery for at least 2 weeks after treatment.
• Increased risk of false-positive HIV tests.
• Avoid blood, organ, or tissue donation after receiving this medicine.
• Also see the serious side effects section.

Before taking this medicine

Tell your doctor if you have ever had:

• neurologic problems (such as stroke, seizures, memory loss);
• breathing problems;
• heart problems;
• liver or kidney disease;
• recent or active infection; or
• low blood counts.

Pregnancy

Carvykti is not recommended for women who are pregnant or for women of childbearing potential not using contraception. Pregnant women should be advised that there may be risks to the fetus. Pregnancy after this therapy should be discussed with the treating physician.

Women will need pregnancy testing before receiving this medicine. You will also need to use birth control to prevent pregnancy during treatment with this medicine. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

Carvykti dosage & administration

Recommended dose: 0.5-1.0×10^6 CAR-positive viable T cells per kg, with a maximum dose of 1×10^8 CAR-positive viable T cells per infusion.

Pre-medication required: Acetaminophen and an H1-antihistamine before infusion.

Administered intravenously at an authorized facility.

Patients should stay within 2 hours of the treatment facility for at least 4 weeks post-infusion for monitoring.

Carvykti Package Insert

HCPs and patients often use the Carvykti Package Insert (PI) for more detailed information about this medicine. The Carvykti Package Insert contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the FDA label, or Carvykti Prescribing Information (PI).

What should I avoid after receiving this medicine?

• Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert for at least 8 weeks after you get Carvykti. This is because the treatment can cause memory and coordination problems, sleepiness, confusion, dizziness, seizures, or other neurologic side effects, as discussed by your healthcare provider.
• You must not be given certain vaccines called live vaccines for some time before and after Carvykti treatment. Talk to your healthcare provider if you need to have any vaccinations.
• Do not donate blood, organs, tissues, or cells for transplantation.

What other drugs will affect Carvykti?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some commercial Human Immunodeficiency Virus (HIV) tests may incorrectly give you an HIV-positive result while you are receiving treatment with Carvykti.

Ingredients

Active ingredient: ciltacabtagene autoleucel

Inactive ingredients: DMSO

Manufacturer Information

Carvykti Manufacturer Janssen Biotech, Inc., Horsham, PA, USA.

Marketing Partner Legend Biotech, Somerset, NJ, USA.

Carvykti Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Carvykti.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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