What is ABECMA? ABECMA (idecabtagene vicleucel) is a prescription medicine for the treatment of multiple myeloma in patients who have received at least three 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.

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Possible side effects with ABECMA

Side effects are possible and should be managed by your healthcare team

Most common side effects

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
  • Coughing
  • Difficulty breathing
  • Fast or irregular heartbeat

When should I call my provider or get immediate help?

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.

What is cytokine release syndrome?

Treatment with ABECMA can sometimes cause a serious side effect called cytokine release syndrome. This happens when the immune cells release a large amount of cytokines into the blood. Cytokines are small immune cell proteins that have many different actions in the body. A large, rapid release of these proteins can be harmful, or in some cases, fatal.

Symptoms of cytokine release syndrome include:

  • Fever
  • Difficulty breathing
  • Dizziness/lightheadedness
  • Nausea
  • Headache
  • Fast heartbeat
  • Low blood pressure
  • Fatigue

You will need to stay in the certified treatment center for at least 7 days after your infusion so that your healthcare team can monitor you for any side effects. Call your doctor if you are experiencing any of these or other symptoms after leaving the hospital.

Side effects are possible and should be managed by your healthcare team.

When can cytokine release syndrome happen, and
how long might it last?

Clinical trial results showing cytokine release syndrome was most likely to happen about a day after ABECMA® (idecabtagene vicleucel) treatment and most likely to improve in 3 days

*The median time to onset was 1 day, with a range of 1 to 27 days.

†The median duration was 5 days, with a range of 1 to 63 days.

In 2 ABECMA clinical studies, most people who experienced cytokine release syndrome had mild to moderate symptoms:

  • 11% of participants (39/349) did not experience cytokine release syndrome
  • 7% of participants (23/349) experienced moderate to severe cytokine release syndrome
  • <1% of participants (3/349) experienced severe or life-threatening cytokine release syndrome

What is neurologic toxicity?

ABECMA can cause a side effect called neurologic toxicity. It affects the body’s nervous system and can be severe, making it hard to think clearly.

Other symptoms of neurologic toxicity include:

  • Confusion
  • Seizures
  • Shaking or twitching
  • Difficulty speaking or slurred speech
  • Disorientation
  • Severe sleepiness

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 receive ABECMA.

You will need to stay in the certified treatment center for at least 7 days after your infusion so that your healthcare team can monitor you for any side effects. Call your doctor if you are experiencing any of these or other symptoms after leaving the hospital.

Side effects are possible and should be managed by your healthcare team.

When can neurologic toxicity happen, and how long might it last?

Clinical trial results showing neurologic toxicity was most likely to happen 3 days after ABECMA® (idecabtagene vicleucel) treatment and most likely to improve in 3 days

*The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events.

†The median time to onset was 2 days, with a range of 1 to 148 days.

In 2 ABECMA clinical studies, most people did not experience neurologic toxicity:

  • 60% of participants (210/349) did not experience neurologic toxicity
  • 4% of participants (14/349) experienced moderate neurologic toxicity
  • <1% of participants (2/349) experienced neurologic toxicity that was severe or life-threatening

In a study comparing ABECMA to standard regimen, a higher proportion of patients experienced death within the first 9 months from randomization in the ABECMA arm compared to the standard regimens arm. This higher rate of early death was mainly observed before receiving ABECMA with the main reason being progression of multiple myeloma. There was also an increase in the rate of death from adverse events after 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.

ABECMA may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.

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

In the weeks following your ABECMA infusion, you will be monitored for side effects.

For the first 7 days after treatment

Monitoring at the treatment center

  • You will stay at the certified treatment center where you got your treatment for at least 7 days after the infusion to
    be monitored for side effects

During weeks 2 to 4

  • You should plan to stay within 2 hours of the certified treatment center for at least 4 weeks after receiving ABECMA.
    Your caregiver will keep an eye on how you're doing, check and record your temperature at least 3 times a day, and take you to scheduled appointments at the treatment center.

After at least 4 weeks of monitoring

Monitor for side effects and tell your doctor right away if you feel symptoms of cytokine release syndrome or neurologic toxicity.

  • 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 receive ABECMA

These are not all the possible side effects of ABECMA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or by visiting http://www.fda.gov/medwatch.

Important Facts About ABECMA®

(idecabtagene vicleucel)

This is a summary of important information that you need to know about ABECMA. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this document in a safe place, so you can refer to it before and during your treatment.

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Helpful information
to remember

What is ABECMA?

ABECMA is a prescription medicine used to treat adults with relapsed or refractory multiple myeloma (MM), when:

you have tried two or more kinds of treatments that have not worked or have stopped working, AND

you have received at least one therapy from each of these drug classes:

  • an immunomodulatory agent
  • a proteasome inhibitor
  • an anti CD38-antibody

WARNING: RISK OF SERIOUS SIDE EFFECTS

ABECMA may cause side effects that are life-threatening and can lead to death, including risk of cytokine release syndrome (CRS), neurologic toxicity, infections, low blood cell counts (cytopenia), and certain types of blood cancers.

Call your healthcare provider or get emergency help right away if you experience any of the following symptoms:

  • trouble breathing
  • fever (100.4°F/38°C or higher)
  • chills or shivering
  •  
  • confusion
  • feeling dizzy or lightheaded
  • shaking or twitching (tremor)
  • fast or irregular heartbeat
  • feeling severely tired or weak
  • severe nausea, vomiting, or diarrhea

Because of the risk of serious side effects, your healthcare provider will give you an ABECMA Patient Wallet Card that describes symptoms to look out for that require emergency medical care right away. It’s 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 a CAR (chimeric antigen receptor) T-cell therapy. It is a prescription medicine made using your own white blood cells. These white blood cells have been changed (genetically modified) to find and attack your multiple myeloma cells. ABECMA is given as an intravenous (IV) infusion.

Before receiving your ABECMA infusion:

Your blood cells will be collected by a process called leukapheresis (LOO-kuh-feh-REE-sis), sometimes called apheresis.

Your blood cells will be sent to a manufacturing site to make your ABECMA. Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary.

Your healthcare provider will give you 3 days of chemotherapy to prepare your body before receiving your ABECMA treatment.

On the day of your ABECMA infusion:

You will receive ABECMA through a tube (catheter) placed into your vein (intravenous infusion). Your dose of ABECMA may be given in one or more infusion bags. Each infusion bag usually takes up to 30 min.

After receiving your ABECMA infusion:

For at least 1 week (7 days) after receiving ABECMA, you will stay at the facility where you received your treatment and be monitored daily.

For 4 weeks after receiving ABECMA, you should plan to stay close (within 2 hours) to the facility where you received your treatment. During this time, 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 any other activity that could be dangerous if you are not mentally alert, for at least 8 weeks after you get ABECMA. This is because ABECMA may affect your ability to be mentally alert in the following ways:

  • temporary memory and coordination problems
  • sleepiness
  • dizziness
  • confusion
  • seizures

Do not donate blood, organs, tissues, or cells for transplantation.

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

Serious side effects

ABECMA can increase the risk of serious side effects. A serious side effect is a side effect that is severe or life-threatening and can lead to death. The serious side effects of ABECMA include, but are not limited to:

Early deaths. In a clinical study comparing ABECMA to standard treatments, a higher proportion of people died in the first 9 months from when they were assigned to receive ABECMA compared to people assigned to receive standard treatments. The higher rate of early death was seen before people received ABECMA, and the main reason was that their multiple myeloma had gotten worse. There was also an increase in the rate of death from side effects after receiving ABECMA.

Cytokine release syndrome (CRS). ABECMA can increase the risk of CRS, a very common side effect which can be severe or fatal. CRS happens when the immune system responds to an infection or a drug more aggressively than it should. Symptoms to look out for include:

  • fever (100.4°F/38°C or higher)
  • trouble breathing
  • dizziness or lightheadedness
  • nausea
  • headache
  • fast heartbeat
  • low blood pressure
  • feeling tired or weak

Infections. ABECMA can increase the risk of life-threatening infections that may lead to death. Symptoms to look out for include:

  • fever (100.4°F/38°C or higher)
  • chills
  • any other signs or symptoms of an infection

Low blood cell counts (cytopenia). ABECMA can lower the amount of one or more types of your blood cells (red blood cells, white blood cells, or platelets), which may make you feel weak or tired, and could increase your risk of severe infection or bleeding. After treatment, your healthcare provider will test your blood to check for this. Symptoms to look out for include:

  • fever (100.4°F/38°C or higher)
  • feeling weak or tired
  • bruising
  • bleeding

Other (secondary) blood cancers. ABECMA may increase your risk of getting certain types of cancers, including certain types of blood cancers. You may hear your healthcare provider call these "secondary hematological malignancies."

Your healthcare provider should monitor you for any signs of secondary cancers.

ABECMA may cause a false-positive HIV (Human Immunodeficiency Virus) test result by some commercial tests.

Call your healthcare provider right away if you have any of these symptoms after receiving ABECMA. Remember to bring and show your ABECMA Patient Wallet Card to any healthcare provider who treats you.

Most common side effects

The most common side effects of ABECMA include:

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

These are not all of the possible side effects of ABECMA.

Talk to your healthcare team for medical advice about side effects. You are encouraged to report side effects to Bristol Myers Squibb at ABECMA.com or by calling 1-888-805-4555, or to the FDA by calling 1-800-FDA-1088.

For more information, please see the U.S. Full Prescribing Information, including Boxed WARNINGS, and Medication Guide for ABECMA. Talk to your healthcare provider for more information about this medication.