Idecabtagene Vicleucel (Abecma®)

How to take Idecabtagene Vicleucel

Idecabtagene vicleucel is given through an intravenous (IV, into a vein) infusion and your dose will be personalized to you. You may be given chemotherapy in the days prior to infusion to prepare your body for treatment with idecabtagene vicleucel. Before the idecabtagene vicleucel 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 human immunodeficiency virus (HIV) prior to receiving this medication. You should ask your care provider prior to receiving any vaccines.

Idecabtagene vicleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. This ensures that the facility where you are receiving this medication is qualified to administer the medication and has the required supportive medications available to treat side effects if you should need them.

You should not drive or operate heavy machinery 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.

Having idecabtagene vicleucel in your blood may cause a false-positive human immunodeficiency virus (HIV) test result by some commercial tests.

Possible Side Effects of Idecabtagene Vicleucel

There are a number of things you can do to manage the side effects of idecabtagene vicleucel. 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

After receiving idecabtagene vicleucel, large numbers of white blood cells are activated and release inflammatory cytokines which can lead to cytokine release syndrome, sometimes severe cases are referred to as cytokine storms. Signs include high fever, lower than normal blood pressure, difficulty 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 immediately if you have any signs or symptoms of cytokine release syndrome so that appropriate treatment can be given.

Neurologic Toxicity including ICANS

This medication can cause neurologic toxicity and immune effector cell-associated neurotoxicity (ICANS). Your care team will be monitoring you very closely for any changes in your mental status. These side effects are usually seen within the first 8 weeks after infusion and include headache, seizure, personality changes, anxiety, disorientation, confusion, agitation, and tremors. If you notice any changes, call your care team right away.

Hemophagocytic Lymphohistiocytosis (HLH)/ Macrophage activation syndrome

In rare cases, this syndrome can occur after CAR-T cell therapy. It causes excess inflammation in your body, leading to persistent fevers, rash, enlarged spleen or liver, hepatitis, jaundice, low blood counts, enlarged lymph nodes, respiratory issues, and altered mental status. You provider will monitor you closely for these syndromes.

Infection and Low White Blood Cell Count (Leukopenia or Neutropenia)

This medication can cause life threatening infections, with or without a decrease in white blood cell counts. Your provider may recommend antimicrobials to decrease the risk of infections.

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 the 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.

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 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).

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.

Muscle or Joint Pain/Aches and Headache

Idecabtagene vicleucel can cause joint or muscle aches and pains, which can interfere with quality of life. Be sure to talk to your oncology care team if you develop this side effect. Be sure to discuss which pain relievers you can safely take with your oncology team, as these are not without their own side effects.

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.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (phosphate, calcium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

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.

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.

Central Nervous System (CNS) Effects

This medication may affect the central nervous system. Some side effects are encephalopathy (disease or damage to the brain that can alter the way your brain works), aphasia (unable to understand or express speech), tremor (involuntary quivering movement, especially of the hands and legs), drowsiness, feeling nervous, headache, dizziness, and weakness. If you have any of these symptoms during or after the infusion of idecabtagene vicleucel, tell your care team right away.

Peripheral Edema

Peripheral edema is swelling of the extremities caused by retention of fluid. It can cause swelling of the hands, arms, legs, ankles and feet. The swelling can become uncomfortable. Notify your oncology care team if you are experiencing any new or worsening swelling.

Less common, but important side effects can include:

• Allergic Reactions: In some cases, patients can have an allergic reaction to this medication. Signs of a reaction can include: shortness of breath or difficulty breathing, chest pain, rash, flushing or itching, or a decrease in blood pressure. If you notice any changes in how you feel during the infusion, let your care team know right away.
• 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.

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 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 medication.