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Dosing for TECELRA is unique—after pre-treatment, it takes a single infusion of your own individualized, engineered T cells to target and destroy synovial sarcoma cells in your body. Learn more about each step of the treatment journey below.
This is how your doctor will determine if you are able to receive TECELRA. You will need:
This is when you undergo
leukapheresis
to collect T cells
that will be engineered to create TECELRA.
TIME: up to 8 hours
Explore more about this procedure.Before receiving TECELRA, you will undergo lymphodepletion, which is a short-course pre-treatment chemotherapy regimen that lasts 4 days. This is different than a normal course of chemotherapy used to treat cancer, as lymphodepletion is intended only to prepare your body to receive your engineered T cells. This 4-day regimen will start 7 days before your TECELRA infusion.
TIME: 4 days
When it's time to receive your uniquely engineered TECELRA, your doctor will thaw your stored T cells and administer premedication. This will consist of an antihistamine and acetaminophen 30 minutes to 1 hour before your infusion to help prevent reactions. Then you will receive your TECELRA infusion, which can come in 1 or more infusion bags, and may take up to 1 hour per bag.‡
TIME: Up to 1 hour for 1 infusion bag‡ + premedication time
After your TECELRA infusion, your doctor and care team will check to ensure your treatment is working and help you with any side effects that may occur. TECELRA may cause side effects that can be severe or life-threatening. To learn more about these side effects, explore the Possible Serious Side Effects page.
After infusion, you will be monitored daily for at least 7 days at the healthcare facility where you received your treatment, and should then remain close to a healthcare facility for the following 3 weeks to continue to monitor for side effects. This means you will be monitored for a total of at least 4 weeks after infusion.
See Important Safety Information, including Important Warning, below.
TIME: For at least 4 weeks
HLA=human leukocyte antigen; MAGE=melanoma-associated antigen.
Positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, -A*02:06P, and negative for HLA-A*02:05P.
A dose of TECELRA may be contained in 1 or more infusion bag(s). A healthcare provider will determine the number of bags needed for your dose of TECELRA before preparing your infusion.
TECELRA is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you. TECELRA is approved based on patient response data. Additional data are needed to confirm the clinical benefit of TECELRA. It is not known if TECELRA is safe and effective in children.
Please see Medication Guide, including Important Warning.
Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.
After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 4 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 4 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.
Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.
The most common side effects of TECELRA include nausea, vomiting, fatigue, infection, constipation, fever (100.4°F/38°C or higher), abdominal pain, difficulty breathing, decreased appetite, diarrhea, low blood pressure, back pain, fast heart rate, chest pain, general body swelling, low white blood cells, low red blood cells, and low platelets.
You are encouraged to report side effects to the FDA at (800) FDA‑1088 or www.fda.gov/
Please see Medication Guide, including Important Warning.
TECELRA is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you. TECELRA is approved based on patient response data. Additional data are needed to confirm the clinical benefit of TECELRA. It is not known if TECELRA is safe and effective in children.
Please see Medication Guide, including Important Warning.
Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.
After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 4 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 4 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.
Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.
The most common side effects of TECELRA include nausea, vomiting, fatigue, infection, constipation, fever (100.4°F/38°C or higher), abdominal pain, difficulty breathing, decreased appetite, diarrhea, low blood pressure, back pain, fast heart rate, chest pain, general body swelling, low white blood cells, low red blood cells, and low platelets.
You are encouraged to report side effects to the FDA at (800) FDA‑1088 or www.fda.gov/
Please see Medication Guide, including Important Warning.
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