Lisocabtagene Maraleucel (Breyanzi®)
Pronounce: LIS-oh-KAB-ta-jeen MAR-a-LOO-sel
Classification: CAR-T Immunotherapy
About Lisocabtagene Maraleucel (Breyanzi®)
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 this Medication
This medication is given through an intravenous (IV) infusion. Your dose will be personalized to you. You may be given chemotherapy in the days prior to the infusion to prepare your body for treatment with this medication. Before the infusion, you will be given pre-medications, including acetaminophen (Tylenol) and an H1 antihistamine, such as diphenhydramine (Benadryl). You will need to be closely monitored after receiving this medication and may need to stay within a certain distance of the treatment facility that infused this medication for several 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 this medication. You should ask your care provider before receiving any vaccines.
You should not drive or operate heavy machinery for at least 2 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
These are some of the most common or most serious side effects of this medication. Talk with your provider about the side effects you are having and how they can be managed.
Cytokine Release Syndrome
Cytokine release syndrome (CRS) is an inflammatory reaction that affects your whole body. This medication can cause a quick and sudden release of cytokines (proteins) from your immune cells into your blood. Your body may become overwhelmed by this release of cytokines. This serious side effect can happen up to 4 weeks after the infusion.
Symptoms of CRS include
- Fever.
- Fatigue.
- Nausea or vomiting.
- Feeling dizzy or lightheaded.
- Headache.
- Trouble breathing or swallowing.
- Swelling of your face.
- Chest pain or racing heartbeat.
- Coughing or wheezing.
This can be a very serious side effect. Let your provider know right away so that treatment can be started if needed.
Neurologic Changes
Your brain, spinal cord, and nerves make up your nervous system. This medication can cause brain (neurological) changes that can affect other parts of your body through your nervous system. These side effects are usually seen within the first 8 weeks after infusion. You may have:
- Headaches.
- Numbness or tingling (neuropathy).
- Motor skill changes, like loss of control of your arms or legs.
- A hard time understanding when someone speaks to you or being unable to speak as you normally would (called aphasia).
- A change in your mental status, such as confusion, extreme tiredness (lethargy), memory loss, being unable to focus, sleep problems, and seeing or hearing things that aren’t really there (hallucinations), among others.
- A lack of blood flow and oxygen to your brain (called encephalopathy).
- Seizures.
Contact your provider if you are having any neurological symptoms.
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 provider if you received high risk therapies.
Infection and Low White Blood Cell Count (Leukopenia or Neutropenia)
This medication can cause serious infections, with or without a decrease in white blood cell counts.
White blood cells (WBC) help your body fight infection. While you are having cancer treatment, your WBC count can drop, putting you at a higher risk of an infection. Tell your provider right away if you have a fever (a 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 for preventing infection:
- Hand washing, both yours and your visitors, is the best way to prevent the spread of infection.
- Avoid large crowds and people who are sick (those who have a cold, fever, or cough, or if someone you live with has these symptoms).
- When working outside, wear clothes that protect you, like long pants and gloves.
- Do not handle pet waste.
- Keep all cuts and scratches clean.
- Shower or bathe daily.
- Brush your teeth at least twice a day.
- Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
- Ask your providers before scheduling dental appointments or procedures.
Ask your providers before you or someone you live with has any vaccines.
Fatigue
Fatigue can cause exhaustion, feeling worn out and that your body is "heavy" and hard to move, or being unable to focus. It is common when you have cancer, and it is not the same as feeling tired. You may need to adjust your schedule to manage fatigue. Plan times to rest during the day and save your energy for more important activities. Exercise can help lessen fatigue. Talk to your providers about ways to deal with this side effect.
Low Platelet Count (Thrombocytopenia)
Platelets are blood cells that help your blood clot. Thrombocytopenia is when your platelet count is lower than normal, and you are at a higher risk of bleeding. Tell your providers if you have any bruising or bleeding, including nose bleeds, bleeding gums, or blood in your urine or stool. If your count gets too low, you may receive platelets from a donor.
- Do not use a razor (an electric razor is fine).
- Do not do activities that can cause injury or bleeding.
- Talk to your provider before taking any non-steroidal, anti-inflammatory medications (NSAIDs) like Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib), and others. These can raise the risk of bleeding.
- Use a soft-bristle toothbrush to brush your teeth. Ask your provider about flossing or using toothpicks.
Muscle or Joint Pain/Aches, Headache, Abdominal (belly) Pain
Your healthcare provider can recommend medications and other strategies to help relieve pain.
Heart Problems (Low Blood Pressure/ Fast Heart Rate)
This medication can cause a lower than normal blood pressure. Your blood pressure will be monitored frequently. Notify 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. This medication can also cause a faster than normal heartbeat, also called tachycardia. If you feel your heart racing or experience palpitations, contact your provider.
Nausea and/or Vomiting
Talk to your providers if you have nausea and/or vomiting. They can prescribe medications to help you. Making changes to your diet can also help. Avoid things that make your symptoms worse, like heavy or greasy/fatty foods and spicy or acidic foods, like tomatoes, lemons, and oranges. Try saltines or ginger ale to help your symptoms.
Call your providers if you cannot keep fluids down for more than 12 hours or if you feel lightheaded or dizzy.
Hypogammaglobulinemia
Hypogammaglobulinemia is low levels of immunoglobulin. This medication can cause low levels of immunoglobulin. Immunoglobulins are antibodies made by your immune system to help you fight infections. Your levels will be checked while on treatment and you may get immunoglobulin if needed. While your levels are low, you are at a higher risk of getting an infection. Talk with your provider before you get any vaccines and about ways you can decrease your chance of an infection.
Decrease in Appetite or Taste Changes
Nutrition is an important part of your care. Cancer treatment can affect your appetite and make it hard to eat. Ask your provider about nutrition counseling services. Some tips you can follow are:
- Try to eat five or six small meals or snacks during the day, instead of 3 larger meals.
- Nutritional supplements may help if you are not eating enough.
- You may have a metallic taste or find that food has no taste. You may dislike foods or beverages that you liked before cancer treatment. These symptoms can last for 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 dressing.
- Use seasonings like basil, oregano, or rosemary to add flavor.
Diarrhea
Diarrhea is when you pass three or more stools in a day. Your providers can suggest medications to relieve diarrhea. Do not take any medications to manage your diarrhea without talking to your provider first, as your stool may need to be tested. To manage it, try eating foods that are low in fiber and bland, like white rice and boiled or baked chicken. Try not to eat raw fruits, vegetables, whole grain breads, cereals, and seeds. Soluble fiber is a type of fiber found in some foods that helps absorb (soak up) fluid. Foods high in soluble fiber are applesauce, bananas (ripe), canned fruit, oranges, boiled potatoes, white rice, foods made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Stay hydrated by drinking 8 to 10 glasses of non-alcoholic, non-caffeinated fluid each day.
Constipation
Constipation is when you have less bowel movements than usual or are having trouble passing stool. To relieve constipation, you can include fiber in your diet (fruits like prunes, apples, peaches, and pear nectars/juices), drink 8 to 10 glasses of non-alcoholic fluids a day, and stay active. Taking a stool softener once or twice a day can prevent constipation. If you do not have a bowel movement for 2 to 3 days, call your provider.
Low Red Blood Cell Count (Anemia)
Anemia is when your red blood cell count is lower than normal. Red blood cells carry oxygen to the tissues in your body. When your red cell count is low, you may feel tired or weak. Tell your providers if you have shortness of breath, trouble breathing, or pain in your chest. If your count gets too low, you may receive a blood transfusion.
Peripheral Edema
Peripheral edema is swelling in your hands, arms, legs, ankles, and feet. It is caused by retention (buildup) of fluid. To help get rid of the fluid, you can elevate (lift up) the affected body part and rest it on a pillow. You may need medications to help your body get rid of the extra fluid, and you may be told to follow a low salt diet. Tell your providers if you have any new or worsening swelling.
Reproductive Concerns
There is a higher risk of health problems for your baby if you are pregnant, become pregnant, or get someone pregnant while on this medication. To lower the risk of birth defects, you should use birth control (contraception) to avoid pregnancy. Talk with your provider about what kind of birth control is safest for you and your partner.
Talk to your provider before breastfeeding while receiving this medication.
Important but Less Common Side Effects
Allergic Reactions
Some people may have an allergic reaction to this medication. Signs of an allergic reaction are:
- Shortness of breath or trouble breathing.
- Chest pain.
- Rash.
- Itching.
- Flushing (reddening of the skin, often on the face, neck, or chest).
- A drop in blood pressure (you may feel lightheaded, dizzy, or weak).
If you have any of these signs while you are getting an infusion, tell your provider right away. The infusion will be slowed down or stopped. Depending on your reaction, you may still be able to get the medication if you are given medicine to prevent a reaction or if the medication is given at a slower rate.