Carvykti (ciltacabtagene autoleucel) is used to treat multiple myeloma, a type of cancer of the bone marrow. Carvykti is used in adults who have multiple myeloma that has returned, or that did not respond to at least 4 other treatments. Carvykti is an immunotherapy that is made from a patient’s own immune cells, which have been collected and genetically modified to be able to find and kill cancer cells.

Carvykti is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy.

Carvykti may cause side effects that are severe or life-threatening and can lead to death.

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with this medicine. Do not have Carvykti therapy if you have an active infection or inflammatory disorder. Severe or life-threatening CRS should be treated with tocilizumab or tocilizumab and corticosteroids.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with this medicine, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. You will be monitored for neurologic events after treatment with this medicine. Supportive care and/or corticosteroids may be needed.

Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with this medicine.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, have occurred in patients following treatment with this medicine. HLH/MAS can occur with CRS or neurologic toxicities.

Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with Carvykti.

Carvykti REMS. This medicine is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Carvykti is available only at an authorized hospital or clinic and must be given by specially trained healthcare professionals.

Carvykti is given after a procedure called leukapheresis (LOO-kuh-fuh-REE-sis). Leukapheresis is a process in which some of your blood is collected through a small tube (catheter) placed into a vein. The catheter is connected to a machine that separates your white blood cells from other parts of the blood. The cells are then sent to a laboratory where they are made into Carvykti, a process that will take 4 to 5 weeks.

About 3 days before your treatment is given, you will be pre-treated with chemotherapy to help prepare your body for Carvykti.

Just before you receive Carvykti, you will be given other medications to help prevent serious side effects or allergic reactions.

Once your body is ready to receive your treatment, your care providers will inject the medicine into a vein through an IV.

You will be watched closely after your injection, to make sure you do not have an allergic reaction or serious side effects.

You will need frequent blood tests to be sure the treatment has not caused harmful effects.

Using this medicine may increase your risk of developing other cancers. Ask your doctor about this risk. You may need cancer screening tests for the rest of your life.

Carvykti may cause false results on a laboratory test for human immunodeficiency virus (HIV). Tell any doctor who treats you that you are using this medicine.

For at least 4 weeks, plan to stay near the hospital or clinic where you received this medicine. Avoid being so far away that it takes you longer than 2 hours to travel back to the hospital.

Recommended Adult Dose Range for Multiple Myeloma: 0.5-1.0×106 CAR-positive viable T cells per kg of body weight, with a maximum dose of 1×108 CAR-positive viable T cells per single-dose infusion.

Comments For autologous use only. For intravenous use only. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of Carvykti.
Premedicate with acetaminophen and an H1-antihistamine.

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 Carvykti therapy should be discussed with the treating physician.

Women will need pregnancy testing before receiving this medicine. You also will 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.

• Do not drive, or 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.

Common Carvykti side effects

• 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.

Serious side effects

Also see Warnings section below.

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

A serious side effect of this medicine 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
• low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

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 the FDA at 1-800-FDA-1088.

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.