What is the Axicabtagene Ciloleucel?
Axicabtagene is used as an immunotherapy to treat adults with large B-cell lymphoma. Axicabtagene is used after two or more other therapies have failed.The Axicabtagene Cioleucel medication is created using the white blood cells that are removed from blood drawn through your vein.Axicabtagene Cioleucel can be obtained under a specific program. The program requires that you register and fully understand all the benefits and risks of the medicine.This medication guide does not list all possible uses of Axicabtagene Cioleucel.
Side effects of Axicabtagene ciloleucel
If you experience any of the following symptoms of an allergy: difficulty breathing, hives, swelling in your lips, face, throat, or tongueCytokine Release Syndrome (CRS), a serious side-effect of axicabtagene, If you experience any of the following symptoms, tell your caregivers immediately: a fever; chills; trouble breathing; or confusion. severe vomiting and severe diarrhea. Fast or irregular heartbeats. Feeling light-headed. If CRS occurs, your caregivers have medications available.Finally, if you experience any of the following symptoms, tell someone or go to an emergency room.
Call your doctor immediately if:
- Headaches, dizziness;
- Anxiety; trouble sleeping
- Unusual thoughts or behaviors
- You may have difficulty understanding or speaking.
- Low blood counts, such as fever, chills, and tiredness. Flu Mouth sores or skin sores easy bruising. Unusual bleeding. Pale skin. Cold hands and feet. Feeling lightheaded.
Side effects associated with axicabtagene include:
- Nausea, diarrhea;
- Low blood cells
- Confuse or confuse
- Fast heartbeats.
There may be other side effects. For medical advice on side effects, call your doctor. Report side effects by calling the FDA at 1-800-FDA-1088.
Warning
A side effect that can be serious is cytokine release syndrome. This condition causes vomiting, nausea, fever, and chills. If this occurs, your caregivers have medications to treat it quickly.Nerve problems can be life-threatening with Axicabtagene Cioleucel. Inform your caregivers if you experience difficulties with speaking, thinking, memory, or confusion.
Before you take this drug
If you've ever:
- Is a chronic or active
- Memory problems
- A seizure;
- Liver or kidney disease
- A stroke;
- If you received a vaccination in the last 2 weeks,
Before receiving this medication, women may be required to undergo pregnancy tests. Birth control may be needed to avoid pregnancy while receiving axicabtagene and chemotherapy.After your baby is born, it may be necessary to test the blood of your child to see if you received axicabtagene during pregnancy. The blood test is done to determine if the medication had any effect on your baby.Breastfeeding may be unsafe while taking this medication. Before undertaking any form of treatment, always consult a medical provider about the potential risks.
How to take Axicabtagene Ciloleucel?
Only authorized hospitals or clinics can provide Axicabtagene Cioleucel. It must also be administered by healthcare professionals who are specially trained.Axicabtagene ciloleucel must be administered through leukapheresis (LOO-kuh-fuh-REE-sis).Leukapheresis is the process of collecting some blood through a catheter placed in a vein. The catheter is attached to a machine that separates white blood cells and other blood components.They are sent to a lab, where they will be made into an axicabtagene celoleucel. As it takes time to convert your blood into axicabtagene, the medication will not be available the day after your blood is drawn.You will receive chemotherapy about 3 to 5 weeks before you are given axicabtagene. This helps prepare your body to accept axicabtagene.You will receive other medicines to prevent side effects and allergic reactions.Your care provider will administer the medicine through an IV once your body is ready.After receiving axicabtagene, you will be closely monitored for 7 days to ensure you don't have any serious reactions or allergic reactions.Blood tests will be required to ensure that axicabtagene isoleucel does not cause any harmful side effects.Plan to live near the clinic or hospital where you were treated with axicabtagene. You should not be so far from the hospital that you have to drive more than two hours.
Details on dosage
Adult dose for lymphoma:Infuse 2 x 10(6) CAR-positive T cells per kg of body weight by IV infusion within 30 minutes.
Maximum Dose: 2 x 10(8) CAR-positive viable T cells
Comments:
Pretreatment: Give a chemotherapy regimen that depletes lymphocytes: Cyclophosphamide 500 mg/m2 intravenously and Fludarabine 30 mg/m2 intravenously on the 5th, 4th, and 3rd days prior to infusion.
Premedication: Give Acetaminophen 650 mg orally and Diphenhydramine 12.50 mg intravenously or orally about 1 hour prior to infusion.
Avoid prophylactic systemic corticosteroids, as they may interfere with this drug's activity.
Use: Relapsed and refractory large-cell lymphoma following 2 or more systemic therapies, such as diffuse B-cell lymphoma, DLBCL, not otherwise specified. Also used for primary mediastinal B-cell lymphoma (HGBCL) and high-grade B-cell lymphoma arising from follicular lymphoma HTML3
What happens if I miss the dose?
If you are unable to attend your scheduled chemotherapy sessions or miss your medication doses, you should call your doctor.
What happens if I overdose?
Overdoses are unlikely because axicabtagene is administered by healthcare professionals in medical settings.
Avoid this
The medicine may cause confusion, memory problems, or seizures. It can also make you feel weak. Do not drive or operate machinery for 8 weeks following treatment with axicabtagene.Consult your doctor prior to receiving a live vaccine. The live vaccines are measles (chickenpox), rubella, mumps (MMR), yellow fever (typhoid), varicella, rotavirus (typhoid), polio (rotavirus), zoster, and influenza (nasal flu).Don't donate any organs, tissues, or cells from your body.
Interaction with other drug
Other medications, such as vitamins and herbs, may interact with axicabtagene. Inform your doctor of all the medicines you are currently taking and those that you will begin or stop using.
