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 nerve problems can occur after treatment with idecabtagene vicleucel. Tell your doctor right away if you have drowsiness, seizure(s), mental/mood changes (such as confusion, anxiety, memory loss), 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.
For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Abecma REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.