What is the most important information I should know about axicabtagene ciloleucel?
A serious side effect of this medicine is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.
Axicabtagene ciloleucel can also cause life-threatening nerve problems. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.
What is axicabtagene ciloleucel?
Axicabtagene ciloleucel is an immunotherapy medicine used to treat large B-cell lymphoma in adults. This medicine is given after at least two other treatments have failed.
Axicabtagene ciloleucel is made using white blood cells removed from blood that is drawn from your body through a vein.
Axicabtagene ciloleucel is available under a special program. You must be registered in the program and understand the risks and benefits of this medicine.
Axicabtagene ciloleucel may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving axicabtagene ciloleucel?
Tell your doctor if you have ever had:
- an active or chronic infection;
- memory problems;
- a seizure;
- liver or kidney disease;
- a stroke; or
- if you have received a vaccine in the past 2 weeks.
Women may need pregnancy testing before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with axicabtagene ciloleucel and chemotherapy.
If you receive axicabtagene ciloleucel during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
How is axicabtagene ciloleucel given?
Axicabtagene ciloleucel is available only at an authorized hospital or clinic, and must be given by specially trained healthcare professionals.
Axicabtagene ciloleucel is given after a procedure called leukapheresis (LOO-kuh-fuh-REE-sis).
During leukapheresis, some of your blood is collected through a small tube (catheter) placed into a vein. The catheter is connected to a machine that separates your white blood cells from other parts of the blood.
The cells are then sent to a laboratory where they are made into axicabtagene ciloleucel. Because it will take time to process your blood cells into axicabtagene ciloleucel, you will not receive the medicine on the same day your blood cells are drawn.
About 3 to 5 days before axicabtagene ciloleucel is given, you will be pre-treated with chemotherapy to help prepare your body for axicabtagene ciloleucel.
Just before you receive axicabtagene ciloleucel, you will be given other medications to help prevent serious side effects or allergic reaction.
Once your body is ready to receive axicabtagene ciloleucel, your care providers will inject the medicine into a vein through an IV.
You will be watched closely for at least 7 days after you receive axicabtagene ciloleucel, to make sure you do not have an allergic reaction or serious side effects.
You will need frequent blood tests to be sure this medicine has not caused harmful effects.
For at least 4 weeks, plan to stay near the hospital or clinic where you received axicabtagene ciloleucel. Avoid being so far away that it takes you longer than 2 hours to travel back to the hospital.
What happens if I miss a dose?
Call your doctor for instructions if you miss any of your chemotherapy treatment, or if you miss a dose of your medications to prevent side effects of axicabtagene ciloleucel.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid after receiving axicabtagene ciloleucel?
This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after you are treated with axicabtagene ciloleucel.
Ask your doctor before you receive a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Do not donate blood, an organ, or any tissues or cells from your own body.
What are the possible side effects of axicabtagene ciloleucel?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
A serious side effect of axicabtagene ciloleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed, or feeling very weak or tired. Your caregivers will have medication available to quickly treat CRS if it occurs.
Also tell your caregivers or seek emergency medical attention if you have signs of life-threatening nerve problems: problems with speech, problems with thinking or memory, confusion, or a seizure.
Also call your doctor at once if you have:
- headaches, dizziness;
- tremors, anxiety, trouble sleeping;
- unusual thoughts or behavior;
- trouble speaking or understanding what is said to you; 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.
Common side effects may include:
- nausea, diarrhea;
- low blood cells;
- confusion; or
- fast heartbeats.
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 FDA at 1-800-FDA-1088.
What other drugs will affect axicabtagene ciloleucel?
Other drugs may affect axicabtagene ciloleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about axicabtagene ciloleucel.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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