What is ABECMA? ABECMA (idecabtagene vicleucel) is a prescription medicine 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.

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Possible
side effects
with ABECMA®

Not an actual patient and caregiver.

How you may be monitored after your ABECMA infusion

After your ABECMA infusion, you may be monitored for signs and symptoms of side effects. Work with your healthcare provider and follow the guidance of your treating physician.

Typical ABECMA timeline

When should I call my healthcare 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.

Common side effects associated
with ABECMA

  • 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

Not an actual patient.

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.

What is cytokine release syndrome (CRS)?

ABECMA can cause a very common side effect called cytokine release syndrome, or CRS, which can be severe or, in some cases, fatal. Cytokines are small immune proteins that have many different actions in the body, and treatments like ABECMA can sometimes cause a large, rapid release of these proteins into the blood, which can be harmful.

What does it feel like to have CRS?

After your infusion, you may want to call your healthcare provider if you experience any of the symptoms below:

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

Specialized healthcare teams are trained to monitor and manage side effects of ABECMA treatment if they occur.

During the ABECMA clinical trial:

  • 15% of participants (19/127) did not report experiencing CRS
  • 76% of participants (96/127) experienced mild or moderate CRS
  • 9% of participants (12/127) experienced severe or life-threatening CRS, with one case leading to death

When might CRS happen, and how long might it last?

Based on the ABECMA clinical trial, CRS associated with ABECMA was likely to happen early, starting about a day after the infusion. In the clinical trial, CRS generally improved in about 7 days.

*The median time to onset was 1 day, with a range of 1 to 23 days.
The median duration was 7 days, with a range of 1 to 63 days.

What are neurologic toxicities?

ABECMA can cause a very common side effect called neurologic toxicity, which can be severe. Neurologic toxicity affects the body’s nervous system.

Neurologic toxicity can be felt as one or more neurological symptoms. 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.

What does it feel like to have neurologic toxicity?

After your infusion, you may want to call your healthcare provider if you experience any of the symptoms below:

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

Specialized healthcare teams are trained to monitor and manage side effects of ABECMA treatment if they occur.

During the ABECMA clinical trial:

  • 72% of participants (91/127) did not report experiencing neurologic toxicity
  • 25% of participants (31/127) experienced mild or moderate neurologic toxicity
  • 4% of participants (5/127) experienced severe neurologic toxicity
  • No participants experienced neurologic toxicity that was life-threatening or led to death

In another multiple myeloma study, other serious side effects, including 1 patient with life-threatening neurologic toxicity, have been reported with ABECMA.

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

In the ABECMA clinical trial, neurologic toxicity was likely to happen early—starting within 2 days after the infusion and improving in about 5 days.

§The median time to onset was 2 days, with a range of 1 to 42 days.
||The median duration was 5 days, with a range of 1 to 61 days in patients whose neurologic toxicity resolved. For patients who experienced neurologic toxicity, including 3 patients with ongoing neurologic toxicity, the median duration of neurologic toxicity was 6 days, with a range of 1 to 578 days.

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.