Jim and his care partner were compensated by Bristol Myers Squibb for sharing their stories.
ABECMA has a well-established side effect profile
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 the safety profile of 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. This 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 days)
How long might it last?
5 days†
after symptoms begin
(range: 1 to 63 days)
Your healthcare team will monitor you for signs of side effects
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 for at least 2 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 days)
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
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 seen before receiving ABECMA. The main reason was progression of multiple myeloma. There was also an increase in the rate of death from side effects after ABECMA.
It’s important to be well informed for conversations with your healthcare team
before deciding on a treatment option.
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 be monitored daily for side effects
During week 2
You should plan to stay close to a treatment center for at least 2 weeks after receiving ABECMA. Your care partner 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 the monitoring period
Monitor for side effects and tell your doctor right away if you feel symptoms of cytokine release syndrome or neurologic toxicity. Do not drive for at least 2 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.
Cecilia and her care partner were compensated by Bristol Myers Squibb for sharing their stories.
