IMPORTANT WARNING:
Ciltacabtagene autoleucel 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 10 days 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 30 to 60 minutes before your infusion to help prevent reactions to ciltacabtagene autoleucel. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, headache, fast or irregular heartbeat, muscle pain, shaking, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, dizziness, or lightheadedness.
Ciltacabtagene autoleucel injection may cause severe, life-threatening, or fatal central nervous system reactions. These reactions can occur days, weeks or months after treatment with ciltacabtagene autoleucel. 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: dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, difficulty with handwriting, agitation, seizures, slow moving, change in personality or loss in interest in usual activities, loss of coordination or balance, weakness, difficulty speaking, or numbness in the face.
Ciltacabtagene autoleucel injection may cause a severe decrease in the number of certain types of blood cells in your blood. This may cause certain symptoms and may increase the risk that you will develop a serious infection or bleeding. Tell your doctor if you have or recently had an infection. If you experience any of the following symptoms after your treatment, tell your doctor immediately: fever, chills, or other signs of infection; feeling tired; or have bruising or bleeding.
Ciltacabtagene autoleucel injection is only available through a special restricted distribution program. A Carvykti REMS program (Risk Evaluation and Mitigation Strategy) has been set up because of the risks of CRS and central nervous system and blood cell problems. 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 ciltacabtagene autoleucel and each time you refill your prescription. 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.
IMPORTANT NOTICE:
Special Alert:
The Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies such as ciltacabtagene autoleucel injection. At this time, benefits still outweigh the risks, but your doctor will monitor you during and after receiving treatment. Talk to your doctor about any concerns you have regarding your treatment.