Tecelra

Pronunciation: Tuh-sel-ruh
Generic name: afamitresgene autoleucel
Dosage form: intravenous infusion

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 6, 2024.

What is Tecelra?

Tecelra is a T-cell immunotherapy used to treat synovial sarcoma in certain patients. Tecelra is a one-time infusion that uses each patient’s own immune cells to recognize and attack the cancer cells. White blood cells are collected from the patient and then modified (engineered) to include T cell receptors (TCR) that can target a protein (antigen) on the cancer cells and destroy them. For Tecelra to work, the cancer cells must have the protein MAGE-A4.

Tecelra's mechanism of action is as a genetically modified autologous T cell immunotherapy. The modified T cells in Tecelra target the antigen MAGE-A4 expressed by synovial sarcoma cancer cells.

Tecelra is FDA-approved for use in unresectable or metastatic synovial sarcoma in patients who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen. Biomarker tests for human leukocyte antigens (HLA) type and melanoma-associated antigen A4 (MAGE-A4) tumor expression are required before treatment with Tecelra. This medicine was approved under the Accelerated Approval pathway.

Clinical trials measured the effectiveness of Tecelra on synovial sarcoma; the overall response rate was 43.2%, and the median duration of response was six months.

Tecelra side effects

The most common Tecelra side effects are nausea, vomiting, tiredness, constipation, fever (100.4°F/38°C or higher), infection, 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. These side effects occur in 20% or more patients.

The most common serious Tecelra side effects are cytokine release syndrome and pleural effusion (abnormal fluid accumulation within the thin space surrounding the lungs). These side effects occurred in 5% or more of patients in clinical trials.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Also, see the Warnings section.

Warnings

Tecelra can cause Cytokine Release Syndrome (CRS), which may be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following symptoms: 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. You will likely be in a hospital before and after getting your infusion. Your healthcare providers administering Tecelra should have immediate access to medications and resuscitative equipment to manage CRS.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Monitor for ICANS events for at least 4 weeks after treatment with this infusion.

Prolonged Severe Cytopenia: Patients may experience low levels of red blood cells (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia) for several weeks following lymphodepleting chemotherapy and Tecelra infusion. Your blood counts will be monitored before and after this infusion.

Infections: You will be monitored for signs and symptoms of infection and then treated appropriately if you have one.

Secondary Malignancies: Patients treated with this medicine may develop secondary malignancies or recurrence of their cancer. Monitor for secondary malignancies.

Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion.

Effects on Ability to Drive and Use Machines: Patients should refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 4 weeks after receiving this infusion.

Before taking this medicine

Before taking Tecelra, tell your healthcare provider about all your medical problems, 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 which can be reactivated following treatment with this infusion
Low blood counts
Taking a blood thinner

Tell your healthcare provider if you are:

breastfeeding, there is no information regarding the presence of Tecelra in human milk, the effect on the breastfed infant, and the effects on milk production.
or think you may be pregnant or plan to become pregnant. Tecelra is not recommended for women who are pregnant, and pregnancy after treatment with this medicine should be discussed with the treating physician.

What should I avoid?

Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 4 weeks after you have this infusion. Do not donate blood, organs, tissues, or cells for transplantation.

How should I take Tecelra?

Tecelra is made from your own white blood cells. Your blood will be collected in a process called leukapheresis (loo-kah-fur-ee-sis), and this gets sent to a company that makes Tecelra for you, which takes about 6 weeks, but the time may vary.

Your healthcare provider may give you other medicines to stabilize your cancer while you wait for Tecelra to be made.
Before you get your Tecelra infusion, you will get 4 days of chemotherapy to prepare your body.

When your Tecelra is ready, a tube (intravenous catheter) is placed into your vein, and your Tecelra infusion is given. This may take up to 60 minutes for each infusion bag.

After having Tecelra, you will be monitored daily at the healthcare facility for at least seven days afterward.

You should plan to stay close to a healthcare facility for at least 4 weeks after treatment so your healthcare provider can check to see that your treatment is working and help you with any side effects that may occur.

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.

Tecelra dosing information

The recommended dose is between 2.68 x 109 to 10 x 109 MAGE-A4 T cell receptor (TCR) positive T cells administered as a single intravenous infusion.

Tecelra is provided as a single dose for infusion in one or more infusion bag(s). Prior to preparation for infusion, verify the number of bags received for the indicated dose.

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Not all possible interactions are listed in this medication guide.