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(ax i cab" tay jeen)
Axicabtagene injection may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). A doctor or nurse will monitor you carefully during your infusion and for at least 4 weeks afterwards. Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. You will be given medications 60 minutes before your infusion to help prevent reactions to axicabtagene. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, fast or irregular heartbeat, shaking, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, confusion, nausea, vomiting, dizziness, or lightheadedness.
Axicabtagene injection may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with axicabtagene. Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, difficulty understanding, or difficulty speaking.
Axicabtagene injection is only available through a special restricted distribution program. A Yescarta REMS program (Risk Evaluation and Mitigation Strategy) has been set up because of the risks of CRS and neurological toxicities. You can only receive the medication from a doctor and healthcare facility that participates in the program. Ask your doctor if you have any questions about this program.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with axicabtagene. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.