Tisagenlecleucel injection is used to treat certain acute lymphoblastic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells) in people 25 years of age or younger that has returned or is unresponsive to other treatment(s). It is also used to treat a certain type of non-Hodgkin’s lymphoma (a type of cancer that begins in a type of white blood cells that normally fights infection) in adults that has returned or is unresponsive after treatment with at least two other medications. Tisagenlecleucel injection is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient’s own blood. It works by causing the body’s immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.
Side Effects Of Tisagenlecleucel Injection
Tisagenlecleucel injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- back pain
Some side effects can be serious. If you experience any of these symptoms or those listed in the WARNING section, call your doctor immediately or get emergency medical treatment:
- unusual bleeding or bruising
- blood in urine
- decreased urination frequency or amount
- swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
- difficulty swallowing
- Tisagenlecleucel injection may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication.
Tisagenlecleucel injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
Warnings & Precautions
Before receiving tisagenlecleucel injection:
- tell your doctor and pharmacist if you are allergic to tisagenlecleucel, any other medications, dimethyl sulfoxide (DMSO), dextran 40, or any other ingredients in tisagenlecleucel injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: steroids such as dexamethasone, methylprednisolone (Medrol), prednisolone, and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have ever had reactions from previous chemotherapy treatments such as breathing problems or irregular heartbeat. Also, tell your doctor if you have or have ever had lung, kidney, heart, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to have a pregnancy test before you start tisagenlecleucel treatment. If you become pregnant while receiving tisagenlecleucel injection, call your doctor immediately. Tisagenlecleucel injection may cause fetal harm.
- you should know that tisagenlecleucel injection may make you drowsy and cause confusion, weakness, dizziness, and seizures. Do not drive a car or operate machinery for at least 8 weeks after your tisagenlecleucel dose.
- do not donate blood, organs, tissues, or cells for transplantation after you receive tisagenlecleucel injection.
- check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor for at least 2 weeks before starting chemotherapy, during your tisagenlecleucel treatment, and until your doctor tells you that your immune system has recovered.
Dosage Of Tisagenlecleucel Injection
Tisagenlecleucel injection comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a doctor’s office or infusion center. It is usually given over a period of up to 60 minutes as a one-time dose. Before you receive your tisagenlecleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for tisagenlecleucel.
About 3 to 4 weeks before your dose of tisagenlecleucel injection is to be given, a sample of your white blood cells will be taken at a cell collection center using a procedure called leukapheresis (a process that removes white blood cells from the body). This procedure will take about 3 to 6 hours and may need to be repeated. Because this medication is made from your own cells, it must be given only to you. It is important to be on time and not to miss your scheduled cell collection appointment(s) or to receive your treatment dose. You should plan to stay within 2 hours of the location where you received your tisagenlecleucel treatment for at least 4 weeks after your dose. Your healthcare provider will check to see if your treatment is working and monitor you for any possible side effects. Talk to your doctor about how to prepare for leukapheresis and what to expect during and after the procedure.
Keep all appointments with your doctor, the cell collection center, and the laboratory. Your doctor may order certain lab tests before, during, and after your treatment to check your body’s response to tisagenlecleucel injection.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving tisagenlecleucel injection. This medication may affect the results of certain laboratory tests.
Ask your pharmacist any questions you have about tisagenlecleucel injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.