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.
This website is best viewed using the horizontal display on your tablet device.
This website is best viewed using the vertical display on your mobile device.
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:
- 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
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 CRS. CRS happens when the immune system responds to an infection or a drug more aggressively than it should, which can be harmful, or in some cases, fatal.
Symptoms of cytokine release syndrome include:
- Fever
- Difficulty breathing
- Dizziness or lightheadedness
- Nausea
- Headache
- Fast heartbeat
- Low blood pressure
- Fatigue
These symptoms may feel similar to the flu. Please talk to your healthcare provider if you experience these symptoms.
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?*†
*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 severe or life-threatening cytokine release syndrome, including 3 patients who experienced cytokine release syndrome leading to death
What is neurologic toxicity?
ABECMA can cause a side effect called neurologic toxicity. It affects the body’s nervous system and can change how the brain works or its structure, 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?*
*The median time to onset was 2 days, with a range of 1 to 148 days.
†T cell–associated neurotoxicity resolved in 123 of 139 (88%) patients and median time to resolution was 5 days (range: 1 to 245 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 at the time of death or data cutoff.
In 2 ABECMA clinical studies, most people did not experience neurologic toxicity:
- 60% of participants (210/349) did not experience neurologic toxicity
- 4.6% of participants (16/349) experienced severe or life-threatening neurologic toxicity
- <1% of participants (1/349) experienced neurologic toxicity leading to death
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 www.fda.gov/medwatch.