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.
ABECMA® has a
well-established side
effect profile
The safety profile of ABECMA is specific to ABECMA and you should discuss it with your doctor. Relapsed/refractory multiple myeloma treatments, including this treatment or any other treatment, may have different side effects, including the types, when and how often they occur, along with how severe they may be. Be sure to talk with your healthcare team to understand all of your treatment options and their potential side effects.
The most common side effects of ABECMA are fatigue, 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, coughing, trouble breathing, and fast or irregular heartbeat. ABECMA may cause side effects that are severe or
life-threatening. Call your healthcare provider or get emergency help right away if you experience severe levels of these side effects, or if you experience shaking or twitching (tremor), severe fatigue, or vomiting.
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.
When can cytokine release syndrome happen, and how long might it last?
When might it start?
1 day*
after infusion
(range: 1 to 27)
How long might it last?
5 days†
after symptoms begin
(range: 1 to 63)
Your healthcare team will monitor you for signs of side effects at the certified treatment center for at least 7 days after your ABECMA infusion.
In 2 ABECMA clinical studies, most people who experienced cytokine release syndrome had mild to moderate symptoms:
*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.
‡Median is the middle number in a group of numbers arranged from lowest to highest.
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.
Call your doctor if you are experiencing any of these or other symptoms after leaving the hospital.
When can neurologic toxicity happen, and how long might it last?
When might it start?
2 days*
after infusion
(range: 1 to 148)
How long might it last?
5 days†
after symptoms begin
(range: 1 to 245 days in 123 out of 139 people whose neurologic toxicity resolved)
Your healthcare team will monitor you for signs of side effects at the certified treatment center for at least 7 days after your ABECMA infusion.
In 2 ABECMA clinical studies, most people did not experience neurologic toxicity:
*The median‡ time to onset was 2 days, with a range of 1 to 148 days.
†T cell-associated neurologic toxicity 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 neurologic toxicity 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.
‡Median is the middle number in a group of numbers arranged from lowest to highest.
Early death
In a study comparing ABECMA to standard regimens, a higher number of patients in the ABECMA group experienced death within 9 months of the start of the trial compared with the standard regimens group. This higher rate of early death was 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.
It’s important to be well informed for conversations with your healthcare team before deciding on a treatment option.
Need help getting started? Download this discussion guide to help you start the conversation.
Monitoring and follow up
In the weeks following your ABECMA infusion, you will be monitored for side effects.
For the first 7 days after treatment
You will stay at the certified treatment center where you received 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.