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Carvykti

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 Jul 9, 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, your T cells (a type of immune cell) are collected and genetically modified to recognize and attack a protein called BCMA, found 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 Carvykti side effects

Common side effects of Carvykti include:

These common side effects occurred in at least 10% of Carvykti patients in the CARTITUDE-4 clinical trial. 

Serious Side Effects

See the boxed warning in the full prescribing information.

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

Warnings & precautions

Before taking this medicine

Tell your doctor if you have ever had:

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?

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.

Does Carvykti interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

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.

Carvykti (ciltacabtagene autoleucel) - Janssen Biotech, Inc.
Formulation type Strength
Bag 0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion

Popular FAQ

What is the success rate for Carvykti for Multiple Myeloma?

In the CARTITUDE-1 study, 95 of 97 of patients with relapsed or refractory multiple myeloma (bone marrow cancer) responded to Carvykti after one infusion for an overall response rate of 98%. Relapsed cancer is cancer that has come back and refractory cancer has stopped responding to treatment. Continue reading

What’s the mechanism of action of Carvykti?

Carvykti is a personalized CAR T cell therapy that works by helping your own white blood cells (called T cells) recognize and fight multiple myeloma, a type of bone marrow cancer. Carvykti is given as a one-time intravenous (IV) infusion of genetically modified T cells called CAR T cells.

Continue reading

Further information

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