Afamitresgene autoleucel (Tecelra®)

This medication is a melanoma-associated antigen A4 (MAGE-A4)-directed autologous (self-directed) T cell immunotherapy cancer treatment used to treat some types of synovial sarcoma. T cells, a key part of your immune system, are removed from your body through an intravenous (IV, from a vein) line through a process called leukapheresis. In a lab, your T cells are modified to increase the number of receptors specifically targeted for the MAGE-A4 antigen found in synovial sarcomas. These T cells are placed (infused) back into your body.  These modified T cell receptors (TCRs) allow the body the ability to find, attack, and kill cancer cells. Your tumor will be tested before treatment for certain antigens that must be on the cancer cells to receive this medication.

How to Take Afamitresgene autoleucel (Tecelra®)

Afamitresgene autoleucel is given through an intravenous (IV, into a vein) infusion. You will be given chemotherapy in the days before the infusion to prepare your body for treatment with afamitresgene autoleucel.

Before the infusion, you will be given pre-medications including acetaminophen (Tylenol) and an H1 antihistamine, such as diphenhydramine (Benadryl), to prevent a reaction. Some people have reactions like fevers, chills, shaking, higher than normal heart rate, rash, low blood pressure, shortness of breath, cough, chest tightness, or wheezing. If you have any changes in how you are feeling, tell your provider right away.

After treatment with afamitresgene autoleucel, you will need to stay in a healthcare facility for at least 7 days. You must stay within close range of your cancer center for at least 4 weeks after treatment. You will not be able to drive or operate heavy machinery for 4 weeks after treatment.

Having afamitresgene autoleucel in your blood may cause a false-positive human immunodeficiency virus (HIV) test result by some commercial tests. Tell all of your care providers that you have received this medication.

Possible Side Effects

There are a number of things you can do to manage the side effects of afamitresgene autoleucel. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Cytokine Release Syndrome (CRS)

Cytokine release syndrome (CRS) can occur. T cells are activated by this medication, causing them to release many cytokines. The cytokines cause an inflammatory response in the body. This reaction, if left untreated, can be very dangerous. Signs and symptoms may be fever, having a hard time breathing, chills, low blood pressure, fast heart rate, headache, and higher levels of liver enzymes in your blood. Your care team will monitor you closely for CRS while you are on therapy with afamitresgene autoleucel. You should call your provider right away if you have any signs or symptoms of CRS so that treatment can be started.

Infection and Low White Blood Cell Count (Lymphocytopenia/Neutropenia)

This medication can cause life-threatening infections, with or without a decrease in white blood cell counts.

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care. Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with, has any vaccinations.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding use of these agents and all over the counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Nausea and/or Vomiting

Nausea, with or without vomiting, can be a side effect. For some patients, it lasts just a few days. You may find that eating or not eating when taking this medication may be helpful. Talk to your healthcare team so they can prescribe medications to help you manage nausea and vomiting.

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen (belly), as these can be signs of liver toxicity.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Constipation

There are several things you can do to prevent or relieve constipation. Include fiber in your diet (fruits and vegetables), drink 8-10 glasses of non-alcoholic fluids a day, and keep active. A stool softener once or twice a day may prevent constipation. If you do not have a bowel movement for 2-3 days, you should contact your healthcare team for suggestions to relieve the constipation.

Fever

Fever can be a side effect of this medication. Call your care provider for a temperature of 100.4°F or 38°C or greater.

Shortness of Breath (Dyspnea)

This medication can make you feel short of breath. Your care team will monitor you closely after treatment with afamitresgene autoleucel. If you have shortness of breath or have a hard time catching your breath after treatment, tell your care team right away.

Abdominal (Belly) and Chest Pain

This medication can cause pain in your abdomen (belly) and chest (not related to your heart). Tell your care team if you start having pain. They will be monitoring you closely during and after your treatment.

Decrease in Appetite

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your oncology care team about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce or dressings. Use seasonings like basil, oregano or rosemary to add flavor. Bacon, ham and onion can add flavor to vegetables.

Diarrhea

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Swelling (Edema)

This medication can cause swelling in your body. The swelling can become uncomfortable. This can also be a sign of other problems, so tell your care team right away if you are having any new or worsening swelling.

Back Pain

Your care team can recommend medication and other strategies to help with pain.

Hypotension (Low Blood Pressure)

This medication can cause a drop in your blood pressure (hypotension). Your blood pressure will be monitored by your healthcare team before, during, and after treatment.

Tachycardia (Fast Heart Rate)

This medication can cause tachycardia, or a higher-than-normal heart rate. Tell your care provider if you feel like your heart is racing, if you become short of breath, dizzy, or faint.

Important but Less Common Side Effects

• Neurologic Toxicity including ICANS (immune effector cell-associated neurotoxicity syndrome): Neurological (brain) toxicities, such as aphasia (being unable to understand speech or speak normally), a change in mental status, encephalopathy (lack of blood flow and oxygen to your brain), and seizures have happened in patients who received this medication. Other neurological side effects can include headaches, neuropathy (numbness or tingling), and/or changes to your motor skills (loss of control, often of the arms or legs). Your care team will be monitoring you very closely for any changes in your mental status.
• Secondary Cancers: A secondary cancer is one that develops as a result of cancer treatment for another cancer. This is quite rare, but you should be aware of the risk. This can occur years after treatment. Your provider will monitor your labs closely. Consider having a complete blood count with differential checked annually by your healthcare provider if you received high risk therapies. There is also a risk of reoccurrence with this medication (the same cancer coming back).
• Allergic Reactions: Some patients may experience an allergic reaction to this medication. This can range from a mild reaction to anaphylaxis. Symptoms of a reaction include itching, flushing, burning, swelling of the face, or difficulty breathing. Report any unusual symptoms to your healthcare provider.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control may be necessary during treatment and for a period of time after your last dose. Talk with your provider about how long you will need to use effective birth control. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while taking this medication.