Glossary of multiple myeloma and CAR T cell therapy terms

CAR=chimeric antigen receptor.

Apheresis is a procedure in which blood is collected, part of the blood such as platelets or white blood cells are taken out, and the rest of the blood is returned to the donor.

B-cell maturation antigen (BCMA) is a specific marker found on plasma cells, including nearly all myeloma cells, making it a target for multiple myeloma treatments.

CAR T cell therapy is a type of treatment in which a patient’s T cells (a type of immune cell) are changed in a laboratory so they will attack target cells with a specific protein on their surface, such as BCMA.

Complete response (CR) or better is a term that means there is no detectable evidence of tumor in the body (all signs of myeloma have disappeared). A CR does not mean the myeloma has been cured.

Duration of response is the length of time a patient continues to respond to therapy without their multiple myeloma growing or spreading.

Follow-up time is the time between infusion and the most recent time point when data on the patient’s outcomes were recorded.

Low-dose chemotherapy, or lymphodepleting chemotherapy, used before CAR T cell therapy, is a short course of anticancer drugs given at lower doses than standard chemotherapy to help prepare your body for treatment.

Median is the middle number in a set of data. This means half the numbers in a group are more than the median and half the numbers in the group are less than the median.

Overall response is the term used when there is a meaningful decrease in signs of myeloma. This includes partial response (a decrease in the amount of myeloma in the body) and complete response.

T cells are a type of white blood cell that are part of the immune system. T cells develop from stem cells found in bone marrow and help protect the body from infection and abnormal cells, including cancer cells.

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Information, including
Boxed WARNINGS and
Medication Guide

Approved Use

What is ABECMA?

ABECMA (idecabtagene vicleucel) is for the treatment of multiple myeloma in patients who have received at least four kinds of treatment regimens that have not worked or have stopped working. ABECMA is a medicine made from your own white blood cells; the cells are genetically modified to recognize and attack your multiple myeloma cells.

Important Safety Information

What is the most important information I should know about ABECMA?

ABECMA may cause side effects that are severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following:

  • difficulty breathing
  • fever (100.4°F/38°C or higher)
  • chills/shivering
  • confusion
  • dizziness or lightheadedness
  • shaking or twitching (tremor)
  • fast or irregular heartbeat
  • severe fatigue
  • severe nausea, vomiting, diarrhea

It is important that you tell your healthcare providers that you have received ABECMA and to show them your ABECMA Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

How will I receive ABECMA?

  • ABECMA is made from your own white blood cells, so your blood will be collected by a process called “leukapheresis”.
  • Your blood cells will be sent to a manufacturing center to make your ABECMA. It takes about 4 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
  • Before you get ABECMA, your healthcare provider will give you chemotherapy for 3 days to prepare your body.
  • When your ABECMA is ready, your healthcare provider will give ABECMA to you through a catheter (tube) placed into your vein (intravenous infusion). Your dose of ABECMA may be given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag.
  • You will be monitored at the certified healthcare facility where you received your treatment daily for at least 7 days after the infusion.
  • You should plan to stay within 2 hours of this location for at least 4 weeks after getting ABECMA. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.

What should I avoid after receiving ABECMA?

  • Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you get ABECMA. This is because the treatment can cause temporary memory and coordination problems, sleepiness, confusion, dizziness, and seizures.
  • Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of ABECMA?

The most common side effects of ABECMA are:

  • fatigue
  • fever (100.4°F/38°C or higher)
  • chills/shivering
  • severe nausea or diarrhea
  • decreased appetite
  • headache
  • dizziness/lightheadedness
  • confusion
  • difficulty speaking or slurred speech
  • cough
  • difficulty breathing
  • fast or irregular heartbeat

ABECMA can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal. Symptoms of CRS include fever, difficulty breathing, dizziness or light-headedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue. Tell your healthcare provider right away if you develop fever or any of these other symptoms after receiving ABECMA.

ABECMA can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

ABECMA can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets), which may make you feel weak or tired or increase your risk of severe infection or bleeding. After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.

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

This is a summary of the most important safety information about ABECMA. These are not all the possible side effects of ABECMA. Call your doctor for medical advice about side effects. For more information, go to www.ABECMA.com or call 1-888-805-4555. You may report side effects to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

Approved Use

What is ABECMA?

ABECMA (idecabtagene vicleucel) is for the treatment of multiple myeloma in patients who have received at least four kinds of treatment regimens that have not worked or have stopped working. ABECMA is a medicine made from your own white blood cells; the cells are genetically modified to recognize and attack your multiple myeloma cells.

Important Safety Information

What is the most important information I should know about ABECMA?

ABECMA may cause side effects that are severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following:

  • difficulty breathing
  • fever (100.4°F/38°C or higher)
  • chills/shivering
  • confusion
  • dizziness or lightheadedness
  • shaking or twitching (tremor)
  • fast or irregular heartbeat
  • severe fatigue
  • severe nausea, vomiting, diarrhea

It is important that you tell your healthcare providers that you have received ABECMA and to show them your ABECMA Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

How will I receive ABECMA?

  • ABECMA is made from your own white blood cells, so your blood will be collected by a process called “leukapheresis”.
  • Your blood cells will be sent to a manufacturing center to make your ABECMA. It takes about 4 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
  • Before you get ABECMA, your healthcare provider will give you chemotherapy for 3 days to prepare your body.
  • When your ABECMA is ready, your healthcare provider will give ABECMA to you through a catheter (tube) placed into your vein (intravenous infusion). Your dose of ABECMA may be given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag.
  • You will be monitored at the certified healthcare facility where you received your treatment daily for at least 7 days after the infusion.
  • You should plan to stay within 2 hours of this location for at least 4 weeks after getting ABECMA. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.

What should I avoid after receiving ABECMA?

  • Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you get ABECMA. This is because the treatment can cause temporary memory and coordination problems, sleepiness, confusion, dizziness, and seizures.
  • Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of ABECMA?

The most common side effects of ABECMA are:

  • fatigue
  • fever (100.4°F/38°C or higher)
  • chills/shivering
  • severe nausea or diarrhea
  • decreased appetite
  • headache
  • dizziness/lightheadedness
  • confusion
  • difficulty speaking or slurred speech
  • cough
  • difficulty breathing
  • fast or irregular heartbeat

ABECMA can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal. Symptoms of CRS include fever, difficulty breathing, dizziness or light-headedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue. Tell your healthcare provider right away if you develop fever or any of these other symptoms after receiving ABECMA.

ABECMA can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

ABECMA can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets), which may make you feel weak or tired or increase your risk of severe infection or bleeding. After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.

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

This is a summary of the most important safety information about ABECMA. These are not all the possible side effects of ABECMA. Call your doctor for medical advice about side effects. For more information, go to www.ABECMA.com or call 1-888-805-4555. You may report side effects to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.