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 observed before receiving ABECMA, with the main reason being progression of multiple myeloma.

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.