Tecelra
Tecelra (afamitresgene autoleucel) is a type of immunotherapy called T‑cell receptor (TCR) therapy. It’s approved for a rare cancer called synovial sarcoma that can't be removed by surgery or has spread in the body. Tecelra is for certain eligible adults. They must have a specific version of the HLA‑A*02 protein and cancer that has the MAGE‑A4 biomarker. Tecelra is made from your own immune cells, which get collected and then engineered in a lab to destroy your cancer cells better. These immune cells are given back as a one-time infusion into your vein. But the whole treatment process can take about 6 weeks. Common side effects include fever, nausea, and fatigue.
What is Tecelra?
What is Tecelra used for?
- Advanced synovial sarcoma in certain adults who are eligible for treatment
How Tecelra works
Tecelra is a type of treatment called T‑cell receptor (TCR) therapy. T cells are part of your immune system that's important for fighting infections and cancer.
With TCR therapy, your care team collects your own T cells and modifies them in a lab. The cells are trained to better recognize a protein on your cancer cells called MAGE‑A4. Then, the modified T cells are given back to you through an infusion into the vein.
Once in your body, these T cells find and attach to the cancer cells and destroy them. This helps the cancer stop growing or spreading.
Drug facts
| Common Brands | Tecelra |
|---|---|
| Drug Class | TCR therapy |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Tecelra
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low white blood cells (up to 98%)
- Low red blood cells (96%)
- Low platelets (82%)
- Cytokine release syndrome (75%)
- Nausea (66%)
- Higher liver enzyme levels (46%)
- Vomiting (36%)
- Fatigue (34%)
- Infection (32%)
- Fever (32%)
- Constipation (32%)
- Stomach pain (25%)
- Shortness of breath (25%)
- Lower appetite (23%)
- Diarrhea (21%)
- Swelling (21%)
- Back pain (21%)
- Low blood pressure (21%)
- Fast heart rate (21%)
Less Common Side Effects
- Headache
- Chills
- Dizziness
- Weakness
- Cough
- Chest pain
- Pain in arm or leg
- High blood pressure
- Hair loss
- Weight loss
Tecelra serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome (CRS): fever, headache, rash, cough, trouble breathing, muscle or joint aches, nausea, vomiting, fast heart rate, low blood pressure.
- Neurologic problem called ICANS: dizziness, sleepiness, trouble focusing, headache, confusion, trouble speaking or thinking, problems with movement, changes in handwriting, seizures
- Very low blood counts: easy bruising or bleeding, bleeding that's hard to stop, blood in your urine or stool, fever, tiredness, shortness of breath
- Infections: fever, chills, night sweats, cough, shortness of breath, feeling very unwell, burning with urination
- Allergic reactions: rash, hives, swelling in your face or lips, chest tightness, trouble breathing
- Abnormal buildup of fluid around the lungs: chest pain, trouble breathing, cough
The following Tecelra side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Constipation
- Fatigue
- Nausea
- Shortness of breath
- Vomiting
Pros and cons of Tecelra
Pros
- Personalized therapy using your own immune cells to fight synovial sarcoma
- Given as a one‑time treatment
- An option when other treatments haven't worked
- Can help shrink the tumor in some people
Cons
- Complex treatment process that can take about 6 weeks
- Risk that there could be delays in treatment (e.g., when making or delivering Tecelra)
- Need several weeks of close follow‑up at a hospital or medical center for serious safety risks
- Only for people with a specific genetic profile and cancer with a specific biomarker
Pharmacist tips for Tecelra
- There are many steps involved in treatment with Tecelra. Your oncology team can explain all the steps in the treatment process in detail. Ask them if you have any questions or concerns.
- Plan ahead to stay at or near the medical center or hospital after your Tecelra treatment. You’ll stay at the medical center or hospital for at least 7 days right after treatment. Then, you'll need to stay close by for another 3 weeks. This makes sure your care team is easy to reach. They can watch for serious risks like cytokine release syndrome (CRS) or infections and treat them as soon as possible.
- Ask your oncologist before taking any steroids around your Tecelra infusion. Steroids might make Tecelra work less well.
- What to expect on treatment day: The nurse will give you acetaminophen (Tylenol) and an antihistamine 30 to 60 minutes before your Tecelra infusion. This helps lower the risk of allergic reactions from the infusion. The infusion is given through a vein and can take an hour or more. This depends on how many infusion bags your Tecelra comes in. Your care team will watch you closely during and after the infusion. Tell your nurse right away if you feel warm or have hives, swelling in your face or lips, or trouble breathing.
- Don't drive or use heavy or dangerous machines for at least 4 weeks after receiving Tecelra. The medication has a risk of making you dizzy, weak, or have trouble focusing during this time. Your care team will tell you when it’s okay.
- Check your temperature often and call your care team if it’s 100.4°F or higher. Fever is often the first sign of infection or CRS. Your care team can give you quick treatment. This can help prevent serious complications.
- Help prevent getting sick after your Tecelra treatment. Your white blood cell count can drop, so it can be easier to get an infection. Wash your hands often and stay away from people who are sick. Tell your care team if you have signs of infection like a fever, chills, a cough, trouble breathing, or burning with urination.
- Watch for unusual bleeding or bruising after Tecelra. Your platelet levels can drop, which can make you bleed or bruise more easily. Tell your care team if you have bruises that don't go away, bleeding that won't stop, frequent nosebleeds, or blood in your urine or stool. These can be signs of serious bleeding.
- Expect frequent blood tests for several weeks after Tecelra. The chemotherapy during pre-treatment and Tecelra can lower your blood cell counts. Regular lab work helps your care team keep you safe. They can decide if you need therapy, like growth factors or blood transfusions, to help get your blood count back up.
- Get medical help right away if you have a headache, dizziness, trouble focusing, trouble breathing, confusion, or a fast heartbeat. Also get help if you have trouble speaking or thinking, problems moving, or a seizure. These can be signs of serious complications from Tecelra.
Risks and warnings for Tecelra
Tecelra can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) is an intense immune reaction that can happen within a few days after you receive Tecelra. It can resolve within a few days to a couple weeks with management. But this reaction can be serious and life-threatening.
Because of the risk of CRS, you’ll be monitored during the Tecelra infusion. You'll continue to be monitored for 4 weeks after treatment.
Symptoms of CRS can include fever, headache, rash, muscle or joint aches, nausea, or vomiting. You might also have a cough, trouble breathing, a fast heart rate, or low blood pressure. These symptoms can get worse and lead to more serious and dangerous problems if not treated.
Tell your care team right away if you have a fever of 100.4°F or higher or any of these CRS symptoms. CRS is treatable when caught early. Your team might give you medications like Actemra (tocilizumab) and steroids to help.
Immune effector cell‑associated neurotoxicity syndrome (ICANS)
Immune effector cell‑associated neurotoxicity syndrome (ICANS) is a serious brain problem. It's happened to someone within days after receiving Tecelra. But with early management and treatment, it can get better quickly.
Signs can include dizziness, sleepiness, trouble focusing, headache, and confusion. More serious signs include trouble speaking or thinking, problems with movement, changes in handwriting, or seizures.
Because of the risk of ICANS, your care team will watch you during the Tecelra infusion. They'll keep checking your thinking and alertness for 4 weeks after treatment.
Watch for signs of ICANS during and after Tecelra treatment. This reaction can cause dizziness, make you less alert, and affect your coordination. So, avoid driving and doing anything risky for at least 4 weeks after the infusion. Get medical care right away if you have sudden confusion, a seizure, or a severe headache.
Severely low blood cell counts
Before you get the Tecelra infusion, you'll first receive chemotherapy as part of the preparation step. This can make your blood cell counts dangerously low. People have had very low blood cell counts after receiving this chemotherapy and the Tecelra infusion. Blood cell counts can stay low for weeks, sometimes for 2 months or longer.
Low red blood cells can cause anemia and make you feel very tired. Low white blood cells can make it easier for you to get sick. And low platelets can cause easy bleeding or bruising. Call your care team right away if you have a fever, unusual bleeding, or signs of infection.
Your care team will monitor your blood counts after the Tecelra infusion. You might need medications called growth factors or blood transfusions. These can help get your blood count back up.
Infections
- Risk factors: Active infection | Inflammatory conditions | History of viral infections (e.g., hepatitis B or C, human immunodeficiency virus)
There's a risk of infection after you get chemotherapy and Tecelra. This is because the chemotherapy used for the preparation step can make your white blood cell count drop. This can make it easier to get sick. Past viral infections can also come back. In studies, about 1 in 3 people had an infection.
Because of this risk, your care team will check for infections before treatment. Tell them about your full medical history. If you have an active infection or an inflammatory condition, you might not be able to get Tecelra.
After your Tecelra infusion, your care team will keep watching for infections. You should also look out for signs of infection. These include fever, chills, cough, shortness of breath, night sweats, or burning with urination. If you notice any of these, call your care team. They can help manage and treat the infection.
Risk of new cancers or cancer coming back
People treated with Tecelra might have a small chance of developing another cancer. There's also a small chance that their cancer could come back.
Go to all your follow‑up visits and routine cancer screenings as your care team recommends you to. Tell your care team if you notice any new or concerning symptoms.
If you're diagnosed with a new cancer, tell your care team that you received Tecelra. Also tell the manufacturer about this new cancer by calling 1-855-246-9232.
Allergic reactions
- Risk factors: Sensitivity to dimethyl sulfoxide (DMSO), an ingredient in Tecelra
Serious allergic reactions, including anaphylaxis, can happen during the Tecelra infusion. Before the infusion, your nurse will give you medications to help prevent or reduce these reactions. They include acetaminophen (Tylenol) and an antihistamine like diphenhydramine (Benadryl).
Your nurse will still watch you closely during the infusion. Tell them right away if you feel flushed or itchy, get hives, have trouble breathing, or have swelling in your face. These reactions need urgent care.
Potential for false‑positive results on HIV testing
Because of how Tecelra is made, a certain type of HIV test might show a false positive after treatment. This means the test might say you have HIV when you actually don't.
If you need an HIV test, tell the clinician and the lab know that you received Tecelra. They might choose a different test to get a more accurate result. This can help avoid confusion and extra unnecessary testing.
Tecelra dosage
Typical dosage for Tecelra
Tecelra is given at a qualified treatment center or hospital. In general, there are a few steps in the treatment process.
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Blood cell collection: The care team collects some of your immune cells from your body. During this procedure, your T cells are separated and collected . The rest of your blood cells are returned back to you. This process takes up to 8 hours.
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Making Tecelra: The collected T cells are sent to a lab. This is where they'll make Tecelra from your T cells and personalize treatment for you. Your modified T cells are tested for quality and then frozen until you're ready. This step takes about 6 weeks, though it can vary.
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Pre-treatment with chemotherapy: To prepare your body for Tecelra, you'll get a short course of chemotherapy. You'll receive fludarabine and cyclophosphamide each day for a few days, starting a week before Tecelra. This helps make room for the modified T cells to grow and work in your body.
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Receiving Tecelra: Tecelra (your modified T cells) is given as a one-time infusion into your vein. Tecelra can come in more than 1 infusion bag. Each bag can take up to 1 hour to infuse.
After treatment, you’ll need to stay at or near the treatment center or hospital for at least 4 weeks. Your care team will monitor you for serious side effects.
Tecelra contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Tecelra will not be safe for you to take.
- Have an HLA‑A*02:05P genetic profile (heterozygous or homozygous)
