This medication may cause serious (even fatal) reactions (cytokine release syndrome-CRS, hemophagocytic lymphohistiocytosis-HLH/macrophage activation syndrome-MAS). Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection. Tell your doctor right away if you have any symptoms such as high fever, trouble breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness, or signs of kidney problems (such as change in the amount of urine).
Serious (even fatal) nerve problems can occur after treatment with ciltacabtagene autoleucel. Nerve problems can occur days or weeks after you receive this medication. Tell your doctor right away if you have mental/mood changes (such as confusion, anxiety, memory loss), drowsiness, seizure, tremor, loss of coordination, numbness/tingling/pain of the hands or feet, leg or arm weakness, facial numbness, difficulty moving the muscles of the face or eyes, or trouble with reading, writing, speaking, or understanding.
This product may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection and any infection you have may get worse. Tell your doctor right away if you have signs of infection (such as a sore throat that doesn't go away, fever, chills, cough), easy or unusual bruising/bleeding, or unusual tiredness.
To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the Carvykti REMS Program. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.