Carvykti

Generic name: Ciltacabtagene Autoleucel
Dosage form: intravenous infusion
Drug class: Miscellaneous antineoplastics

Usage of Carvykti

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 side effects

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.

Before taking Carvykti

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.

Relate drugs

How to use Carvykti

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.

Warnings

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).

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.

Popular FAQ

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

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