Carvykti (ciltacabtagene autoleucel) is a prescription drug used to treat certain types of multiple myeloma. Carvykti comes as a liquid suspension for intravenous (IV) infusion given just one time.

Carvykti is used in adults to treat multiple myeloma that either:

Carvykti belongs to the group of drugs called CAR-T cell therapies.

To learn more about this drug’s uses, see the “What is Carvykti used for?” section.

Carvykti basics

Carvykti contains the active ingredient ciltacabtagene autoleucel.

Carvykti is a biologic drug, which means it’s made from parts of living organisms. It’s available only as a brand-name drug and not in a biosimilar form. Biosimilars are like generic drugs. But unlike generics, which are made for non-biologic drugs, biosimilars are made for biologics.

Carvykti has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). For details, see the “What should be considered before taking Carvykti?” section.

Carvykti is used to treat multiple myeloma that has either:

Your doctor may prescribe Carvykti if you’ve already received:

Multiple myeloma is a cancer that starts in the plasma cells of your bone marrow, where healthy cells are made. These cancer cells can multiply quickly and crowd out healthy cells. In early stages, you may not notice symptoms. As the cancer progresses, you may experience kidney problems, bone damage, and changes in the levels of calcium and iron in your blood.

Carvykti is made from your own white blood cells. T cells (a type of white blood cell) are altered in a lab to help your immune system better fight the cancer. Then the T cells are put back into your body through an intravenous (IV) infusion (an injection into a vein given over time). In this way, Carvykti works to treat multiple myeloma.

Like most drugs, Carvykti may cause mild to serious side effects. The lists below contain some of the more common side effects the drug may cause but don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Carvykti. They can also suggest ways to help reduce or manage them.

Mild side effects

Here’s a list of some of the mild side effects Carvykti can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read the drug’s prescribing information.

Mild side effects of Carvykti that have been reported include:

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Carvykti can occur. If you have serious side effects from this drug, call your doctor right away. If you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported with Carvykti include:

* For more information, see the “What should be considered before taking Carvykti?” section.

Allergic reaction

Based on the drug’s studies, Carvykti can cause an allergic reaction in some people.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should keep taking Carvykti.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Carvykti, they may have you switch to a different treatment.

Below is the commonly prescribed dosage of Carvykti, but the dosage you receive will be determined by your doctor. They’ll recommend the dosage that’s right for you.

Form and strength

Carvykti is made from your own white blood cells. Once your blood is collected, it’s sent to a lab. This lab alters your T cells (a type of white blood cell) to help them better fight cancer. This is a type of CAR-T cell therapy. The amount of T cells you receive from your modified blood depends on your body weight and factors specific to your cancer.

Carvykti is a liquid suspension (a type of liquid mixture). It’s given as an intravenous (IV) infusion (an injection into a vein over a period of time). You’ll receive just one Carvikti infusion. This is a complete treatment course.

Recommended dosage

The usual dose of Carvykti is a single IV infusion injected into your vein slowly over the course of 30 to 60 minutes. You’ll then stay where you received the infusion for 10 days so you can be monitored for side effects. After that, you should stay close to where you received the infusion for 4 weeks to be checked by your doctor at regular intervals.

Carvykti is made from your own white blood cells. Once your blood is collected, it’s sent to a lab. This lab alters your T cells to help them better fight cancer. This is a type of CAR-T cell therapy. The amount of T cells you receive from your modified blood depends on factors specific to your cancer and your weight in kilograms (kg). (1 kg equals approximately 2.2 pounds.)

How to take

Your doctor will explain how Carvykti will be given to you. They’ll also explain how much you’ll be given.

First, your white blood cells will be collected in a lab. This usually takes 3 to 6 hours, but you may have to do this collection more than once. Then your white blood cells will be sent to a specialty lab where they’ll alter your T cells to help them fight cancer better. This may take around 4 to 5 weeks.

Three days before your Carvykti infusion, you’ll be given chemotherapy. Then 30 to 60 minutes before your Carvykti infusion, you’ll receive acetaminophen and an antihistamine, such as diphenhydramine (Benadryl). This is to help reduce the severity of side effects.

Your Carvykti infusion will then be given as an IV infusion injected into a vein slowly over the course of 30 to 60 minutes.

To learn more about the Carvykti infusion process, check out the drugmaker’s website.

Questions about receiving Carvykti

Below are some common questions about receiving Carvykti.

  • What if I miss a dose of Carvykti? Carvykti is given as just one infusion. If you think you’ll miss your infusion appointment, call your doctor’s office as soon as possible to reschedule and receive further instructions.
  • Will I need to use Carvykti long term? No. Carvykti is given just one time.
  • How long does Carvykti take to work? Carvykti begins to work right after your infusion. While you may experience side effects, you likely won’t feel the drug working to fight the cancer in your body. Your doctor will order tests at varying intervals to make sure the drug is working to treat your condition.

Below is important information you should consider before Carvykti treatment.

Interactions

Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works. These effects are called interactions.

Carvykti is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer doesn’t list any interactions with these items in the drug’s prescribing information.

Before starting Carvykti treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Carvykti interaction with lab tests and vaccines

Carvykti can interact with the following lab tests and vaccines:

  • HIV: Carvykti may interact with certain tests that detect HIV. If you’ve received Carvykti, certain HIV tests may return a false positive. (This means the test could indicate that you have HIV when, in fact, you do not. This is because of how your own cells are modified to create Carvykti.)
  • Live vaccines: You should not receive live vaccines* for at least 6 weeks before starting Carvykti treatment, as this increases your risk of infection. Examples of live vaccines include those for measles, mumps, rubella (MMR), rotavirus, and chickenpox. If you need to receive a vaccine, talk with your doctor first to make sure it’s safe.

* Live vaccines contain weakened versions of the bacteria or virus they’re meant to protect against.

Pregnancy and breastfeeding

It’s not known whether it’s safe to take Carvykti during pregnancy or while breastfeeding. If you’re pregnant, your doctor will likely recommend you not receive Carvykti.

If you’re pregnant or breastfeeding, or planning to become pregnant or to breastfeed, talk with your doctor before starting Carvykti treatment.

Birth control

It’s not known how long females* who can become pregnant or males* with partners who can become pregnant should use a highly effective form of birth control after receiving Carvykti. In the drug’s studies, females and males were told to use highly effective birth control for 1 year after their Carvykti infusion.

* In this article, we use the terms “male” and “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

Boxed warnings

Carvykti has boxed warnings for the risks of cytokine release syndrome (CRS), neurologic toxicities, certain dangerous immune system conditions, lower than normal blood cell counts, and developing certain other types of blood cancers. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Carvykti’s boxed warnings include:

Risk of CRS: Carvykti helps your immune system fight cancer. But your immune system could go into overdrive while attacking cancer cells, which may lead to CRS. This condition causes inflammation and various other symptoms depending on its severity. Mild symptoms of CRS include fever, dizziness, and fatigue. But if CRS becomes severe, you may experience respiratory failure, high heart rate, or low blood pressure.

If you develop CRS, your doctor will likely prescribe tocilizumab (Actemra) or a corticosteroid such as dexamethasone to help. Due to the risk of CRS, your doctor won’t give you a Carvykti infusion if you have an active infection or another condition that causes inflammation.

Risk of neurologic toxicities: Carvykti may damage your brain or spinal cord, which may cause neurologic toxicities. Mild symptoms of neurologic toxicities include changes in your handwriting, confusion, or peripheral neuropathy. More severe neurologic toxicities include seizure, parkinsonism, Guillain-Barré syndrome, or problems with the nerves in your brain.

If you develop neurologic toxicities, your doctor will likely prescribe a corticosteroid, such as dexamethasone, or a medication to prevent seizure, such as levetiracetam (Keppra). Due to this risk, you should avoid any activities where you need to be mentally alert (such as driving) for at least 8 weeks after receiving Carvykti. If you develop symptoms of neurologic toxicities, you’ll need to wait to restart these activities until your doctor tells you to.

Due to the risks of CRS and neurologic toxicities, Carvykti is only available through a risk evaluation and mitigation strategy (REMS) program. The FDA requires REMS programs for certain drugs to help make sure they’re administered safely.

Risk of certain dangerous immune system conditions: Carvykti may increase your risk of certain types of dangerous immune system conditions. Symptoms of these conditions include serious problems in your kidneys or lungs, in addition to severe bleeding.

Risk of having lower than normal blood cell counts: Carvykti may lower the amount of certain cells in your blood (white blood cells, red blood cells, or platelets). These levels may stay low for long periods of time. Or they may revert to being low after returning to normal ranges. If your blood cell counts are lower than normal, you may be more prone to infection, bruise or bleed more easily, or have less color in your skin. To correct low blood cell counts, your doctor may recommend a stem cell transplant in certain situations.

Risk of developing certain other types of blood cancer: Carvykti may increase your risk of certain types of other blood cancers, such as myelodysplastic syndrome and acute myeloid leukemia. Your doctor will monitor you for these conditions. If you develop one of these cancers any time after receiving Carvykti, you or your doctor should call the manufacturer, Janssen Biotech, at 800-526-7736 to report it and determine the next steps.

Due to these risks, you’ll stay in the facility where you received Carvykti for 10 days so you can be monitored. You’ll then stay close to this facility for another 4 weeks to be periodically checked.

Warnings

Carvykti can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Carvykti is a good treatment option for you. Talk with your doctor about your health history before receiving Carvykti. Be sure to tell them if any of the following factors apply to you:

Whether you have health insurance or not, price may be a factor when considering Carvykti. A program called MyCARVYKTI Patient Support Program is available. Visit the program’s website to learn more and see if you’re eligible.

Other drugs are available that can treat your condition. Abecma (idecabtagene vicleucel) is another CAR-T cell therapy for multiple myeloma that’s either returned after being successfully treated or hasn’t responded to other therapies.

Abecma and Carvykti work in a similar way and are both one-time infusions used to treat multiple myeloma. They also have similar side effects. There are slight differences in when you would qualify for Abecma or Carvykti based on which multiple myeloma treatments you’ve tried in the past.

If you’d like to explore an alternative to Carvykti, talk with your doctor. They can tell you about other medications that might work well for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.