Generic Name: brexucabtagene autoleucel
Trade Name: Tecartus®
For which conditions is Tecartus approved for? TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
This indication is approved under accelerated approval based on overall response rate and durability of response; continued approval may be contingent upon efficacy verification in ongoing clinical trials.
The labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and or life-threatening side effects including cytokine release syndrome (CRS) and neurological toxicities. Because of these risks, TECARTUS is being approved with a risk evaluation and mitigation strategy (REMS).
What is the mechanism of action? TECARTUS is a genetically-modified personalized immune cell therapy; a patient’s own white blood cells are genetically modified to recognize and attack mantle cell lymphoma cells that express a specific protein called CD-19.
How is TECARTUS typically given (administered)? Each dose of TECARTUS is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. Your T-cells are collected in a 3-6 hour procedure called leukapheresis and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill mantle cell lymphoma cells that have a specific antigen, CD-19, on the surface. Before you get TECARTUS, your healthcare provider may give you chemotherapy for three days to prepare your body. Once the cells are modified, TECARTUS is infused.
How are patients typically monitored? Patients will be monitored daily for 7 days after receiving TECARTUS and will usually have scheduled meetings with their healthcare provider while for the leukapheresis procedure, chemotherapy, treatment with TECARTUS, and follow up after treatment. Typically, blood will be drawn before and after treatment to check levels of blood cells and to monitor for low white blood cell counts and infections. In addition, patients may undergo physical examinations, scans, or other measures to assess side effects and response to therapy. You should plan to stay close to the location where you received your treatment for at least 4 weeks after treatment with TECARTUS.
What are the most common side effects of treatment with TECARTUS?
- Low white blood cells
- Low red blood cells
- Low blood pressure
- Fast heartbeat
- Difficulty speaking or slurred speech
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how TECARTUS works and can cause side effects.
- Tell your healthcare provider about all your medical conditions including neurologic problems, lung or breath problems, heart problems, liver problems, kidney problems or a recent or active infection.
- TECARTUS may cause severe or life-threatening side effects and it is important that you call your healthcare provider right away if you experience symptoms of CRS, infection, or neurologic toxicities. If you seek emergency care, it is important to let your healthcare providers know that you have received TECARTUS.
Are there any special precautions patients should be aware of before starting treatment?
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- You should plan to stay close to the location where you received your treatment for at least 4 weeks after treatment with TECARTUS.
- Do not operate heavy machinery or drive for at least 8 weeks after you receive TECARTUS; TECARTUS can cause sleepiness, confusion, dizziness and seizures as well as memory problems.
- Do not donate blood, organs, tissues or cells for transplantation.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. TECARTUS may cause severe or life-threatening side effects and it is important that you call your healthcare provider right away or seek emergency help if you experience:
- Difficulty breathing
- Chills or shaking chills
- Dizziness or lightheadedness
- Severe nausea, vomiting or diarrhea
- Fast or irregular heartbeat
- Severe fatigue or weakness
If you seek emergency care, it is important to let your healthcare providers know that you have received TECARTUS.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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