Obecabtagene Autoleucel (Aucatzyl®)

This medication is a CD19-directed genetically-modified autologous (self-directed) T cell immunotherapy cancer treatment. T cells, part of your immune system, are removed from your body through an IV line by a process called leukapheresis. In a lab, they add a chimeric antigen receptor (CAR) to your T cells. These T cells are infused back into your body. CAR gives the T cells the ability to identify, attack and kill cancer cells.

How to Take Obecabtagene Autoleucel (Aucatzyl®)

Obecabtagene autoleucel is given through an intravenous (IV, into a vein) infusion on two separate days and your dose will be personalized to you. You will be given chemotherapy in the days before the infusion to prepare your body for treatment with obecabtagene autoleucel.

Before the obecabtagene autoleucel infusion, you will be given acetaminophen (Tylenol) as a pre-medication. You will need to be closely monitored after receiving obecabtagene autoleucel and may need to stay within a certain distance of the treatment facility that infused this medication for at least 4 weeks after the dose has been given.

Viruses in your body may reactivate after treatment with this medication. It is standard to be tested for hepatitis b, hepatitis c, and HIV prior to receiving obecabtagene autoleucel. You should ask your care provider before receiving any vaccines.

You should not drive or operate heavy machinery, or work a hazardous job for at least 8 weeks after the medication is given. This medication can cause side effects that can affect your ability to do these tasks.

You should not donate blood, tissue, cells, or organs after receiving this medication.

Possible Side Effects

There are a number of things you can do to manage the side effects of obecabtagene 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)

After receiving obecabtagene autoleucel, large numbers of white blood cells are activated and release inflammatory cytokines which can lead to cytokine release syndrome (CRS), sometimes severe cases are referred to as cytokine storms. Signs include high fever, low blood pressure, having a hard time breathing, severe nausea and vomiting, severe diarrhea, chills/shaking, severe muscle and joint pain, and bleeding. This serious side effect can happen up until 4 weeks after the infusion. You should call your provider right away if you have any signs or symptoms of cytokine release syndrome so that appropriate treatment can be given.

Neurologic/Central Nervous System (CNS) Effects

This medication may cause serious neurologic (brain and central nervous system) issues. These side effects are usually seen within the first 8 weeks after infusion, and include headache, seizure, personality changes, anxiety, drowsiness, weakness, disorientation, confusion, agitation, encephalopathy (disease or damage to the brain that can affect the way your brain works), aphasia (unable to understand or express speech), dizziness, and tremors (involuntary quivering movement, especially of the hands and legs). Call your care provider right away if you are having any of these changes.

Secondary Cancers

A secondary cancer is one that develops as a result of cancer treatment for another cancer. This medication can cause a secondary T cell malignancy (cancer). This is quite rare, but you should be aware of the risk. This can occur as soon as weeks after treatment with this medication, or years after treatment. Your provider will monitor your labs closely. You should be monitored for T cell malignancies for the rest of your life. Consider having a complete blood count with differential checked annually by your healthcare provider if you received high risk therapies.

Infection and Low White Blood Cell Count (Lymphocytopenia, Leukopenia or 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 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.

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.

Muscle or Joint Pain/Aches, Headache

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy /fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines or ginger ale to lessen symptoms. Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

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 to 10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Hypotension (Low Blood Pressure)

This medication can cause a lower-than-normal blood pressure. Your blood pressure will be monitored frequently. Call your care provider if you become lightheaded, dizzy, or your skin becomes clammy. Low blood pressure can lead to fainting so be careful in your daily activities such as showering, driving, or operating any type of machinery.

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.

Important but Less Common Side Effects

• Hypogammaglobulinemia: This medication can cause lowered levels of immunoglobulin. Your levels will be monitored and immunoglobulin will be administered as needed. While your levels are low, you are at an increased risk of getting an infection. Be sure to follow the recommendations above to decrease the chance of an infection. You should not receive any vaccines without talking with your oncology team first.
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome: This is a rare but serious side effect that causes inflammation of the immune system. If you have persistent fevers, fatigue, headache, feel foggy, enlarged lymph nodes, enlarged liver and spleen, bleeding, clotting issues, rash, change in blood pressure or heart rate, liver is not working right, or low blood counts, contact your provider right away.
• Allergic (Hypersensitivity) Reaction: In some cases, patients can have an allergic reaction to this therapy. Signs of a reaction can include: shortness of breath or difficulty breathing, rash, and flushing. If you notice any changes in how you feel during the infusion, let your nurse know immediately. The infusion will be slowed or stopped if this occurs. Depending on the severity of your reaction, you may still be able to receive the therapy with a pre-medication to prevent a reaction, or if the therapy is given at a slower rate.

Reproductive Concerns

Exposure of an unborn child to this therapy could cause birth defects, so you should not become pregnant or father a child while on this therapy or for a year after having received it. Effective birth control is necessary during treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should consult with your healthcare team before breastfeeding while receiving this therapy.