Patient Medication Information: uses, side effects, how to take - Tecartus
What is Tecartus used for:
- Tecartus is a treatment for your mantle cell lymphoma (MCL) and acute lymphoblastic leukemia (ALL) – two forms of white blood cell cancer.
- For MCL, it is used when at least two other available medicines have stopped working for you.
- For ALL, it is used when at least one other available medicine has stopped working for you.
How Tecartus works:
Tecartus is made from your own white blood cells. Some of these cells are taken from your body and then genetically modified to make Tecartus. Tecartus is given to you by drip (infusion) into a vein. Tecartus recognizes and attacks your lymphoma cells.
The ingredients in Tecartus are:
Serious Warnings and Precautions
Tecartus can cause serious side effects that are life-threatening. Sometimes, these serious side effects that are life-threatening can lead to death. The serious adverse effects of Tecartus include the following:
You will only be given Tecartus by an experienced healthcare professional at specialized treatment centres. |
- Medicinal ingredients: brexucabtagene autoleucel
- Non-medicinal ingredients: Cryostor®, sodium chloride, human serum albumin
Tecartus comes in the following dosage forms:
Tecartus comes as a cell suspension in one infusion bag. The entire content of the bag should be given to you by drip into a vein as a single, one-time treatment.
Do not use Tecartus if:
- You are allergic to Tecartus or any of the other ingredients of this medicine (Read “What are the ingredients in Tecartus?” above).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Tecartus. Talk about any health conditions or problems you may have, including if you:
- Have a brain tumour or any other types of cancer.
- Have had a stem cell transplant and any related side effects from the transplant such as graft versus host disease (GVHD), or any other organ transplant in the past.
- Have or have had problems with the heart, blood pressure, lung, liver or kidney.
- Have had blood clots in the body.
- Have any symptoms of CRS (severe systemic inflammation), such as chills, high fever, feeling weak or very tired, nausea, vomiting, diarrhea, muscle or joint pain, dizzy, headache, cough, shortness of breath, or fast or irregular heartbeat.
- Have any symptoms of neurologic problems, such as fits, stroke, shaking, difficulty speaking or swallowing, confusion, delirium, memory loss, seizure, loss of balance, loss of consciousness or decreased level of consciousness.
- Have any symptoms of infection, such as fever (100.4°F/38°C), chill, sore throat, coughing, chest pain, stomach pain, vomiting, and diarrhea.
- Have any symptoms of low red blood cells, such as feeling weak or very tired, and shortness of breath.
- Have any symptoms of low platelets (a type of blood cell), such as bleeding or bruising more easily.
- Had or have hepatitis B or C or HIV (human immunodeficiency virus).
- Had a vaccine in the previous 6 weeks or are planning to have one in the next few months.
- Have any symptoms of severe allergic reactions, such as shortness of breath or trouble breathing, skin rash, swelling of the lips, tongue, or face, chest pain, feeling dizzy or faint.
- Have any symptoms of tumour lysis syndrome, such as nausea, vomiting, diarrhea, muscle cramps or twitches, weakness, numbness or tingling, feeling tired, less urine, irregular heartbeat, confusion, restless, delirium or seizure.
Are pregnant, think you are pregnant or plan to become pregnant.
- Are a man and you plan to father a child after Tecartus treatment.
- Are breast-feeding or plan to do so.
Other warnings you should know about:
Do not drive, use heavy machinery, or do other dangerous things for 8 weeks after you get Tecartus because the treatment can cause sleepiness, confusion, weakness, memory and coordination problems.
- Do not donate blood, organs, tissues and cells for transplantation after Tecartus treatment.
- Cases of progressive multifocal leukoencephalopathy (PML) have been reported following use of other CAR T products. PML is a rare brain infection that can be fatal. Tell your doctor right away if you notice or someone notices in you: progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes. Your doctor may request further testing if PML is suspected.
Tell your doctor about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Tecartus:
- Corticosteroids use prior to Tecartus infusion may make Tecartus less effective.
- Vaccines: Tecartus may make some vaccines less effective. It may not be safe for you to receive live viral vaccine (a type of vaccine made from weakened virus) during or shortly after Tecartus.
How will I receive Tecartus:
- Since Tecartus is made from your own white blood cells, your blood will be collected by a process called “leukapheresis” (loo-kah-fur-ee-sis), which will remove some of your white blood cells and concentrate them.
- Your blood cells will be sent to a manufacturing centre to make your Tecartus.
- Before you get Tecartus, you will get 3 days of chemotherapy to prepare your body.
- When your Tecartus is ready, your healthcare professional will give it to you through a catheter placed into your vein (intravenous infusion). The treatment usually takes less than 30 minutes.
- You will be monitored where you received your Tecartus daily for at least 7 days after the treatment. You should plan to stay close to the location where you received your treatment for at least 4 weeks after getting Tecartus. Your healthcare professional will help you with any side effects that may occur.
- You may be hospitalized for side effects and your healthcare professional will discharge you if your side effects are under control, and it is safe for you to leave the hospital.
- Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it.
- Always show the Patient Alert Card to the doctor or nurse when you see them or if you go to hospital.
- Your healthcare professional will want to do blood tests to follow your progress. It is important that you do have your blood tested. If you miss an appointment, call your healthcare professional as soon as possible to reschedule.
- You will be asked to enrol in a registry, maintained by the Center for International Blood and Marrow Transplant Research (CIBMTR), in order to better understand the long-term effects of Tecartus. Additional information can be obtained from: contactus@cibmtr.org.
Usual dose:
Tecartus comes as a cell suspension in one infusion bag. The target dose is 2 × 106 manufactured live T-cells (that is CAR T-cells) per kg body weight; with a maximum of 2 × 108 CAR T- cells (if you weigh 100 kg or higher) for MCL and 1 × 106 anti-CD19 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 108 CAR-positive viable T cells (if you weigh 100 kg or higher) for ALL. The entire content of the bag should be given to you as a single, one-time treatment.
Possible side effects from using Tecartus:
These are not all the possible side effects you may feel when taking Tecartus. If you experience any side effects not listed here, contact your healthcare professional.
Very common:
- Fever, chills, headache, difficulty in speaking, agitation, shaking, feeling sick, constipation, diarrhea, pain in the stomach or being sick
- Shortness of breath, cough
- Low levels of antibodies called immunoglobulins, which may lead to infections
- Muscle pains, back pain
- Extreme tiredness
- Changes in rate of the heartbeat
- Decreased appetite, sore mouth
- Difficulty sleeping, anxiety
- Swelling
- Rash
- Infections caused by fungi and bacteria
- Blurred vision
- Excessive bleeding
- Changes to the colour of the skin
Common:
- Dry mouth, dehydration
- Loss of control of body movements
- Increase of the pressure inside your skull
Serious side effects and what to do about them
| Frequency/Side-effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| High fever, chills, difficulty breathing, nausea, vomiting, diarrhea, muscle pain, joint pain, low blood pressure, or dizziness/light headedness (possible symptoms of cytokine release syndrome [CRS]) | ✓ | ✓ | |
| Fits (seizures), shaking, loss/decreased level of consciousness, confusion, loss of balance or coordination, difficulty self-caring, difficulty reading, writing, and understanding (possible symptoms of neurologic problems) | ✓ | ✓ | |
| Feeling warm, fever, chills or shivering; depending on the location of infection, you may also experience cough, difficulty breathing, painful urine or blood in urine, sore throat, or chest pain (possible symptom of infections) | ✓ | ✓ | |
| Weakness, loss of energy, rapid heartbeat, shortness of breath, pale skin, low level of red blood cells in blood test (possible symptoms of low level of red blood cells) | ✓ | ||
| Spontaneous bleeding or bruising (possible symptoms of low levels of blood platelets or thrombocytopenia) | ✓ | ||
| Spontaneous or prolonged and excessive bleeding (coagulopathy) | ✓ | ✓ | |
| Very little or no urine (possible symptoms of acute kidney injury) | ✓ | ||
| Blood clots that lower blood flow (thrombosis) | ✓ | ||
| Changes in functioning or rhythm of the heart (tachycardias, bradycardias, non-ventricular arrythmias) | ✓ | ||
| Dizziness, light headedness caused by low blood pressure (hypotension) | ✓ | ||
| Headache or dizziness caused by high blood pressure (hypertension) | ✓ | ||
| Shortness of breath, fast heartbeat, blue discolouration of lips or extremities (possible symptoms of hypoxia) | ✓ | ||
| Chest pain, cough, shortness of breath, caused by fluid around the lungs (pleural effusion) | ✓ | ||
| State of severe confusion (delirium) | ✓ | ✓ | |
| Reduced level of sodium in the blood, sometimes leading to nausea, headache, drowsiness, restlessness, irritability muscle weakness and cramps (hyponatremia) | ✓ | ||
| Reduced level of phosphate in the blood, sometime leading to muscle weakness (hypophosphatemia) | ✓ | ||
| Reduced levels of potassium in the blood, possibly leading to muscle weakness, muscle spasms, abnormal heart rhythm (hypokalemia) | ✓ | ||
| Reduced levels of calcium in the blood, possible leading to muscle spasms, numbness of the hands, feet, or lips (hypocalcemia) | ✓ | ||
| COMMON | |||
| Low number of white blood cells in your blood test; you may or may not have an infection at the same time (neutropenia or febrile neutropenia) | ✓ | ||
| Extreme shortness of breath or difficulty breathing, feeling suffocated, anxious, restless, cough, frothy sputum with or without blood, blue coloured lips, or | ✓ | ✓ | |
| fast heartbeat, caused by fluid in the lungs (possible symptoms of pulmonary edema) | |||
| Difficulty to swallow (dysphagia) | ✓ | ✓ | |
| A syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme inflammation such as fever, malaise, yellow colour of your skin and eyes (hemophagocytic lymphohistiocytosis/macrophage activation syndrome [HLH/MAS]) | ✓ | ✓ | |
| Breathlessness, difficulty breathing when lying down (possible symptoms of heart failure) | ✓ | ✓ | |
| RARE | |||
| Symptoms of new cancer including new lymphoma or leukemia from a type of white blood cells called T-cells. If you have T-cell leukemia this might include symptoms of fever, feeling weak, bleeding gums, bruising. If you have T-cell lymphoma, this might include symptoms of unexplained fever, feeling weak, night sweats, sudden weight loss | ✓ | ✓ | |
Progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes (Progressive multifocal leukoencephalopathy [PML]) | ✓ | ✓ | |
Producing less urine than normal and/or muscle spasms, possible symptom of an increase in potassium, phosphate and uric acid in the blood that can cause kidney problems (possible symptom of tumour lysis syndrome) | ✓ | ✓ | |
| Severe headache, weakness, loss of consciousness (possible brain herniation) | ✓ | ✓ | |
| Fever, chills, shivering, nausea, vomiting, tiredness, dizziness, pain where the infusion needle is inserted, blisters, itching, and/or shortness of breath or wheezing during or shortly after infusion (possible infusion-related reaction) | ✓ | ✓ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
If you want more information about Tecartus:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html ); the manufacturer’s website www.gilead.ca, or by calling 1-866-207-4267.
Date of Authorization: July 20, 2026
Kite Pharma, Inc.
Santa Monica, CA 90404
USA
Manufactured for:
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 7K2
Tecartus® is a trademark of Kite Pharma, Inc., a wholly owned subsidiary of Gilead Sciences, Inc.
All other marks referenced herein are the property of their respective owners.
© 2026 Kite Pharma Inc.
e230191-GS-006