Full Prescribing Information

Medication Guide

REMS Website

Indications

For US Healthcare Professionals >

WHAT ARE THE POSSIBLE SIDE EFFECTS OF BREYANZI®?

Home > How Breyanzi Can Help > Potential Side Effects

YOUR HEALTHCARE TEAM KNOWS WHAT TO LOOK FOR DURING TREATMENT WITH BREYANZI AND IS PREPARED TO MANAGE SIDE EFFECTS THAT MAY OCCUR

The most common side effects of Breyanzi are:

  • Fatigue
  • Difficulty breathing
  • Fever (100.4°F/38°C or higher)
  • Chills/shaking chills
  • Confusion
  • Difficulty speaking or slurred speech
  • Severe nausea, vomiting, diarrhea
  • Headache
  • Dizziness/lightheadedness
  • Fast or irregular heartbeat
  • Swelling
  • Low blood pressure
  • Muscle pain

Breyanzi can increase the risk of life-threatening infections that may lead to death, can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets), and may increase the risk of getting cancers including certain types of blood cancers. Tell your healthcare provider right away if you develop fever, chills, signs of an infection, feel tired or have bruising or bleeding. 

These are not all the side effects with Breyanzi. See possible serious side effects below.

It is important that you tell your healthcare providers that you have received Breyanzi and to show them your Breyanzi Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

Phone call
CALL YOUR HEALTHCARE PROVIDER OR GET EMERGENCY HELP RIGHT AWAY IF YOU HAVE ANY OF THE SIDE EFFECTS LISTED ABOVE OR BELOW

POSSIBLE SERIOUS SIDE EFFECTS TO KNOW ABOUT

Breyanzi may cause severe side effects that are life-threatening and can lead to death. Your healthcare team is trained to manage the side effects of Breyanzi, such as cytokine release syndrome (CRS) and neurologic toxicity (NT).

Let your healthcare team know if you experience any signs or symptoms of CRS or NT.

Warning symbol CYTOKINE RELEASE SYNDROME (CRS)

Cytokine release syndrome (CRS) happens when the immune cells release a large amount of proteins, called cytokines, into the blood.

Across the Breyanzi clinical trials, 54% experienced cytokine release syndrome, with severe cases occurring in 3.2% of people.*

  • Some symptoms of CRS include fever, low blood pressure, chills, fast heart rate, headache, and not enough oxygen getting into the tissues of the body
  • CRS was most likely* to happen around 5 days after infusion (range 1-63 days) and most likely* to improve around 5 days after onset (range 1-37 days)

*Based on median days from the clinical study.

Warning symbol NEUROTOXICITY (NT)

Neurologic toxicity, or NT, is a serious side effect that can cause damage to the nervous system.

Across the Breyanzi clinical trials, 31% of people experienced neurologic toxicity, with severe cases occurring in 10% of people.

  • NT can cause brain disease, shaking, difficulty speaking, headache, and can make it hard to think clearly
  • NT was most likely* to happen around 8 days after infusion (range 1-63 days) and most likely* to improve around 7 days after onset (range 1-119 days)

Important Facts About
BREYANZI®
(lisocabtagene maraleucel)

This is a summary of important information that you need to know about BREYANZI. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this document in a safe place, so you can refer to it before and during your treatment.

Look out for the following icons as you read:

Conversation bubbles

Talk to your
healthcare team

Phone call

Call your healthcare
provider right away

Information

Helpful information
to remember

What is BREYANZI?

BREYANZI is a prescription medicine used to treat four types of non-Hodgkin lymphoma in adults with:

Large B cell lymphoma (LBCL), when:

checkmark

your first treatment has not worked or cancer has returned within 1 year; OR

checkmark

your first treatment has not worked or cancer has returned, and you cannot receive hematopoietic stem cell transplantation (HSCT); OR

checkmark

you have tried two or more types of treatment that have not worked or stopped working.

X mark

BREYANZI cannot be used to treat primary central nervous system (CNS) lymphoma.

Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), when:

checkmark

you have tried two or more types of treatment that have not worked or have stopped working, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.

Follicular lymphoma (FL), when:

checkmark

you have tried two or more types of treatment that have not worked or have stopped working.

Mantle cell lymphoma (MCL), when:

checkmark

you have tried two or more types of treatment that have not worked or have stopped working, including a Bruton tyrosine kinase (BTK) inhibitor medicine.

Information

BREYANZI is different than other cancer medicines because it is made from your own white blood cells, which have been genetically modified to recognize and attack your lymphoma cells.

WARNING: RISK OF SERIOUS SIDE EFFECTS

A serious side effect is a side effect that may be life-threatening and can lead to death.

Warning symbol

BREYANZI may cause serious side effects including cytokine release syndrome (CRS) and neurologic toxicity.

Phone call

Call your healthcare provider or get emergency help right away if you experience any of the following symptoms:

  • trouble breathing
  • fever (100.4°F/38°C or higher)
  • chills/shaking chills
  • confusion
  • severe nausea, vomiting, or diarrhea
  • fast or irregular heartbeat
  • dizziness or lightheadedness
  • feeling very tired or weak
Warning symbol

BREYANZI may increase your risk of getting certain cancers, including specific types of blood cancers.

These are not the only serious side effects. See below for additional side effects.

Because of the risk of serious side effects, your healthcare provider will give you a BREYANZI Patient Wallet Card that describes symptoms to look out for that require emergency medical care right away.

Marked checkbox

Carry this card with you at all times during and following your treatment with BREYANZI. Your healthcare provider may give you other medicines to treat your side effects.

Marked checkbox

It’s important to tell your healthcare providers that you have received BREYANZI and to show your Patient Wallet Card to any other healthcare provider who treats you.

What should I discuss with my healthcare team before starting BREYANZI?

Conversation bubbles

Talk to your healthcare provider about all of your medical conditions, including if you have or have had:

  • nervous system problems (including seizures, stroke, or memory loss)
  • lung or breathing problems
  • liver problems
  • heart problems
  • kidney problems
  • a recent or current infection
Conversation bubbles

Talk to your healthcare team about all the medicines you are taking, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements
Conversation bubbles

Talk to your healthcare provider if you have recently received or are scheduled to receive a vaccine (immunization)

Vaccination with live virus vaccines should be avoided for at least 6 weeks prior to start of chemotherapy, during BREYANZI treatment, and until your immune system recovers following treatment with BREYANZI.

What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding?

Conversation bubbles

Talk to your healthcare team if:

Pregnancy symbol

You are pregnant or plan to become pregnant – BREYANZI may harm your unborn baby

If you are able to become pregnant, your healthcare team should do a pregnancy test before starting treatment with BREYANZI.

Phone call

Call your healthcare provider right away if you become pregnant or think you are pregnant during treatment with BREYANZI.

Breastfeeding symbol

You are breastfeeding or plan to breastfeed

It is not known if BREYANZI passes into your breast milk. Talk to your healthcare team about the best way to feed your baby at this time.

How will I receive BREYANZI?

BREYANZI is different than other cancer medicines because it is a prescription medicine made from your own white blood cells and given as an intravenous (IV) infusion. These cells are genetically modified to recognize and attack your lymphoma cells.

Waiting for your BREYANZI dose to be prepared:

Blood bag

BREYANZI is made from your own white blood cells, so your blood will be collected by a process called “leukapheresis” (LOO-kuh-feh-REE-sis) or “apheresis.”

Calendar

Your white blood cells will be sent to a manufacturing site and be used to prepare your BREYANZI. It takes about 3-4 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.

Before receiving BREYANZI:

Chemotherapy medicine bag

You will get 3 days of chemotherapy to prepare your body before receiving your BREYANZI treatment. Your BREYANZI treatment will usually happen 2-7 days after receiving chemotherapy.

While receiving BREYANZI:

Hourglass

You will receive BREYANZI as an intravenous (IV) infusion of 2 different cell types. These infusions will be given one after the other. Each infusion may take approximately 15 minutes but time will vary.

After receiving BREYANZI:

Calendar

For 1 week after receiving BREYANZI, you will be monitored daily at the facility where you received your treatment.

For at least 4 weeks after getting BREYANZI, you should plan to stay close (within 2 hours) to the facility where you received your treatment. During this time:

  • Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.
  • You may be hospitalized for side effects. Your healthcare provider will discharge you if your side effects are under control, and it is safe for you to leave the hospital.

Long-term monitoring:

Blood collection vial

Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested.

What if I miss a blood test appointment?

Phone call

Call your healthcare provider as soon as possible to reschedule your appointment.

What should I avoid after receiving BREYANZI?

X mark

Do not drive, operate heavy machinery, or do any other activity that could be dangerous if you are not mentally alert, for at least 8 weeks after you get BREYANZI. BREYANZI may affect your ability to be mentally alert in the following ways:

  • temporary memory and coordination problems
  • sleepiness
  • confusion
  • dizziness
  • seizures
X mark

Do not donate blood, organs, tissues, or cells for transplantation

What are the possible or reasonably likely side effects of BREYANZI?

Serious side effects

BREYANZI can increase the risk of serious side effects. A serious side effect is a side effect that may be life threatening and can lead to death. The side effects of BREYANZI include, but are not limited to:

Cytokine release syndrome (CRS) and neurologic toxicity. BREYANZI can increase the risk of CRS and neurologic toxicity, two very common serious side effects which can be fatal or life-threatening. CRS happens when the immune system responds to an infection or a drug more aggressively than it should. Neurologic toxicity is a serious side effect of the nervous system and may cause a condition that could change how the brain works or its structure.

Symptoms to look out for include:

  • trouble breathing
  • fever (100.4°F/38°C or higher)
  • chills/shaking chills
  • confusion
  • severe nausea, vomiting, or diarrhea
  • fast or irregular heartbeat
  • dizziness or lightheadedness
  • feeling very tired or weak
Phone call

Call your healthcare provider right away if you have any symptoms of CRS or neurologic toxicity.

Remember to bring and show your BREYANZI Patient Wallet Card.

Infections. BREYANZI can increase the risk of life-threatening infections that may lead to death.

Symptoms to look out for include:

  • fever (100.4°F/38°C or higher)
  • chills
  • any other signs or symptoms of an infection
Conversation bubbles

Talk to your healthcare team about other signs of infection to look out for.

Phone call

Call your healthcare provider right away if you have any symptoms of an infection.

Low blood cell counts (cytopenia). BREYANZI can lower the amount of one, or more, types of your blood cells (red blood cells, white blood cells, or platelets). Your healthcare provider will test your blood to check for this.

Symptoms to look out for include:

  • fever (100.4°F/38°C or higher)
  • feeling tired
  • bruising
  • bleeding
Phone call

Call your healthcare provider right away if you have any symptoms of low blood cell counts.

Other cancers. BREYANZI may increase your risk of getting cancer, including certain types of blood cancers. You may hear your doctor call these secondary hematological malignancies or T cell malignancies.

Information

Your healthcare provider should monitor you for any signs of other cancers.

BREYANZI may cause a false-positive HIV (human immunodeficiency virus) test result by some commercial tests.

Most common side effects

The most common side effects of BREYANZI include:

  • feeling tired
  • trouble breathing
  • fever (100.4°F/38°C or higher)
  • chills/shaking chills
  • confusion

 

  • trouble speaking or slurred speech
  • severe nausea, vomiting, or diarrhea
  • headache
  • dizziness or lightheadedness
  • fast or irregular heartbeat
  • swelling
  • low blood pressure
  • muscle pain

These are not all of the possible side effects of BREYANZI.

Conversation bubbles

Talk to your healthcare team for more information about side effects. You are encouraged to report side effects to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Information

For more information, please see the U.S. Full Prescribing Information, including Boxed WARNINGS, and Medication Guide for BREYANZI. Talk to your healthcare provider for more information about this medication.

Bristol Myers Squibb® logo

© 2024 Juno Therapeutics, Inc., a Bristol Myers Squibb company. All Rights Reserved.

BREYANZI and the related logo are trademarks of Juno Therapeutics, Inc., a Bristol Myers Squibb company.



2009-US-2400823, 2009-US-2400825 12/24