Carvykti (Ciltacabtagene Autoleucel) for Multiple Myeloma

Carvykti (ciltacabtagene autoleucel) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treating adults with multiple myeloma.

How Carvykti Works and How It’s Taken

Carvykti is made from your own T cells, which are white blood cells. Some of your own cells are removed from your body by a healthcare professional. These cells are changed to recognize B-cell maturation antigen (BCMA), a marker found on multiple myeloma cells.

After the cells are given back to you, they can attach to BCMA-expressing cancer cells and help destroy them. This is a type of CAR T-cell therapy.

Doctors prescribe Carvykti for adults with multiple myeloma. It is used when at least one other treatment has not worked or has stopped working.

Typical Dosing for Multiple Myeloma

Carvykti is given as a one-time intravenous infusion (given into a vein) that takes approximately 30 to 60 minutes. Carvykti is made from your own white blood cells.

Your blood is collected using a process called leukapheresis. Your cells are then sent to a lab to make Carvykti. This process usually takes about four to five weeks, but timing can vary.

Before you receive Carvykti, your doctor will give you chemotherapy for three days to prepare your body. The Carvykti infusion is given two to four days after the chemotherapy is finished.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Carvykti Side Effects

In clinical trials of Carvykti in adults with multiple myeloma, the most common side effects were reported in about 10 percent to 96 percent of people. They include:

Fever of 100.4 degrees Fahrenheit/38 degrees Celsius or higher
Chills
Dizziness or lightheadedness
Headache, muscle or joint pain, and feeling very tired
Altered mental state and confusion
Infections
Low levels of immunoglobulins (antibodies) in the blood
Cough and being short of breath
Diarrhea, nausea, decreased appetite, and constipation
Fast or irregular heartbeat
Problems with blood clotting

Serious Side Effects and Warnings

Carvykti can cause serious side effects that require immediate medical attention. These include:

Cytokine release syndrome — A strong immune reaction that can cause fever, trouble breathing, low blood pressure, and can be life-threatening
Neurologic toxicities — Nervous system problems that can be severe, life-threatening, or fatal
Hemophagocytic lymphohistiocytosis/macrophage activation syndrome — A rare, severe immune overreaction that can be life-threatening
Prolonged or recurrent cytopenias — Low blood cell counts that can increase the risk of serious bleeding, severe anemia, or serious infections
Serious infections — Severe or fatal infections can happen, including COVID-19
Hypogammaglobulinemia — Low levels of antibodies in the blood that can increase the risk of serious infections
Hypersensitivity reactions, including anaphylaxis — A severe allergic reaction that can cause trouble breathing, chest tightness, or low blood pressure
Immune effector cell-associated enterocolitis — Severe or long-lasting diarrhea and stomach pain that can lead to serious complications
Increased risk of secondary cancers — New cancers that can develop after treatment

Get medical help right away if you think you are having a serious side effect from Carvykti.

How To Save on Carvykti

Janssen Biotech, the manufacturer of Carvykti, offers the MyCARVYKTI Patient Support Program. Eligible people prescribed Carvykti may be able to get support with travel-related expenses during treatment at an Activated Treatment Center, including transportation, lodging, meals, and other out-of-pocket travel expenses.

To learn more, visit the Carvykti resources and support page or call 800-559-7875.

What To Know Before Taking Carvykti

Tell your doctor if you have any allergies to ciltacabtagene autoleucel or any ingredients in Carvykti. Serious allergic reactions, including anaphylaxis, may occur and may be related to an ingredient in Carvykti known as dimethyl sulfoxide (DMSO).

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, and supplements.

Before you receive Carvykti, tell your healthcare provider about all your medical conditions, including if you have:

Current or past neurologic problems, such as seizures, stroke, or new or worsening memory loss
Lung or breathing problems
Heart problems
Liver problems
Kidney problems
A recent or active infection
Low blood counts

If you are pregnant, planning to become pregnant, or breastfeeding while taking Carvykti, talk with your doctor about the risks and benefits. Carvykti is not recommended to be given during pregnancy. Your doctor will verify pregnancy status before starting Carvykti.

If you can become pregnant, use effective birth control during treatment.

Community FAQs

How effective is Carvykti?
In one study of adults with multiple myeloma who had at least one prior treatment, more people responded to Carvykti than to standard therapy, 84.6 percent compared to 67.8 percent. Carvykti also helped people live longer without their disease getting worse. At 12 months, 75.9 percent of people who received Carvykti had no disease progression, compared with 49.5 percent of people who received standard therapy.

How long does Carvykti take to work for multiple myeloma?
The exact time it takes Carvykti to work is not known. After one infusion, the modified T cells start to grow and expand in the body. As they grow, levels of myeloma markers, like M-protein and free light chains, may go down.

The CAR T cells usually reach their highest levels about 12 to 13 days after the infusion.

What monitoring and precautions are needed after Carvykti for multiple myeloma?
After receiving Carvykti, you will be monitored at the certified healthcare facility where you received your treatment for at least seven days after the infusion. You should plan to stay close to the location where you received your treatment for at least two weeks. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.

You may be hospitalized if you develop serious side effects until your side effects are under control and it is safe for you to leave the hospital. Your doctor will do blood tests to monitor your condition after treatment.

Do not drive for at least two weeks after receiving Carvykti. Live vaccines should not be given for at least six weeks before the chemotherapy that is given before Carvykti, during treatment, and until your immune system has recovered. Do not donate blood, organs, tissues, or cells for transplantation after receiving Carvykti.