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Overview: Breyanzi is used to treat certain blood cancers. Common side effects include fever, tiredness, and nausea. Get emergency help if you have trouble breathing, fever of more than 100.4 F (38 C), confusion, fast heart beat, dizziness, or severe tiredness, nausea, or diarrhea. Breyanzi is an infusion into your vein (IV) that is given by your healthcare provider.

Uses

What is Breyanzi used for?

Breyanzi (lisocabtagene maraleucel) is commonly used to treat certain kinds of the following blood cancers. 

Learn more about Breyanzi for Large B-Cell Lymphoma

Breyanzi may also be used for other conditions as determined by your healthcare provider.

How does Breyanzi work (mechanism of action)?

Breyanzi is a type of medicine known as cellular therapy. It is a personalized treatment that uses your own immune system cells to create the medicine. This allows Breyanzi to work to kill your specific cancer cells. 

How is Breyanzi supplied (dosage forms)?

Brands and other names

  • Breyanzi

Dosage forms and strengths

Breyanzi is available in an injectable form that is given by a healthcare provider.

How should I store Breyanzi?

Breyanzi is usually given by a healthcare provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Breyanzi?

The most common side effects of Breyanzi are listed below. Tell your healthcare provider if you have any of these side effects that bother you. Your side effects may vary depending on the condition you are being treated for.

  • Fever or chills
  • Tiredness
  • Shortness of breath
  • Muscle and bone pain
  • Dizziness
  • Nausea or diarrhea
  • Headache
  • Blood disorders (see below)
  • Encephalopathy
  • Swelling

There may be other side effects of Breyanzi that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Breyanzi?

While less common, the most serious side effects of Breyanzi are described below, along with what to do if they happen.

Severe Allergic Reactions. Breyanzi may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Overactive Immune Response. Breyanzi can cause dangerous and life-threatening conditions called cytokine release syndrome (CRS) and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). Both occur when your immune system responds too much to medicines, cancer, or infection. Get emergency help if you have any of the following symptoms even several weeks after you use Breyanzi.

  • Fever or chills
  • Fast or racing heart
  • Dizziness or feeling lightheaded
  • Trouble breathing
  • Severe nausea, vomiting, or diarrhea
  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Severe headache

Neurologic Problems. Breyanzi can cause neurological problems, including a condition called immune effector cell-associated neurotoxicity syndrome (ICANS). Get emergency help if you have any of the following symptoms.

  • Confusion
  • Seizures
  • Balance problems
  • Trouble talking 
  • Tremor

Infections. Breyanzi can increase your risk of infections, including serious infections. Call your healthcare provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee
  • Cough or coughing up blood 
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Hepatitis B Virus Reactivation. If you have hepatitis B virus in your body or have had hepatitis B in the past, Breyanzi could make the virus active again. Keep all appointments for blood work before starting Breyanzi and during treatment. Call your healthcare provider right away if you have any of the following symptoms of hepatitis.

  • Unusual tiredness
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Nausea, vomiting, or loss of appetite
  • Dark-colored pee
  • Fever or chills
  • Pain in your side
  • Stool (poop) that is clay-colored    

Blood Disorders. Breyanzi can cause blood disorders, such as low red blood cells (anemia), low platelet levels (thrombocytopenia), and low neutrophils (neutropenia) including febrile neutropenia, which can lead to dangerous infections. Keep all appointments to have your blood checked. Get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Low Antibodies. Breyanzi may cause you to have low levels of certain types of antibodies, called immunoglobulins. Low immunoglobulin levels could increase your risk for infection. Keep all appointments to check your blood work after getting this medicine.

Cancer. Breyanzi can cause a new cancer to develop. Tell your healthcare provider about any new symptoms that you may get.

Warnings & Precautions

Who should not use Breyanzi?

Allergies to Ingredients. People who are allergic to any of the following should not use Breyanzi.

  • Lisocabtagene maraleucel
  • Breyanzi
  • Any of the ingredients in the specific product dispensed

Your healthcare provider can tell you all of the ingredients in Breyanzi.

What should I know about Breyanzi before using it?

Breyanzi is given by a healthcare provider in a hospital or clinic. 

Breyanzi has to be made from your own immune cells, so it will take several weeks for the medicine to be ready. Talk with your healthcare provider about what to expect from the process. 

Breyanzi is given as a single dose. Your healthcare provider will give you certain medicines on a specific schedule before you receive Breyanzi. Make sure to attend all appointments and take all medicines they give you as instructed.

Breyanzi can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination for at least eight weeks after receiving Breyanzi.

You should not donate blood, tissues, organs, or any cells meant for transplants after using Breyanzi. 

After using Breyanzi, it is possible that blood tests will give you a false-positive test result for HIV. Tell every healthcare provider you see that you have received Breyanzi. 

What should I tell my healthcare provider before using Breyanzi?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Breyanzi is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Neurologic problems including previous or current seizure, stroke, or memory loss
  • Lung or breathing problems
  • Heart problems
  • Liver problems
  • Kidney problems
  • A recent or active infection
  • Hepatitis B, hepatitis C, or HIV

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines six weeks before Breyanzi, during treatment, and until your immune system recovers after Breyanzi. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Pregnancy. Do not use Breyanzi if you are pregnant or think you may be pregnant. It is not known if Breyanzi may cause harm to an unborn baby, but it may cause serious problems if it reaches the baby.  Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will likely give you a pregnancy test before you use Breyanzi. Talk with your healthcare provider if you would like to get pregnant after using this medicine.

Breastfeeding. It is not known if Breyanzi passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Breyanzi?

For more information about Breyanzi, you can visit the manufacturer’s website at www.breyanzi.com or call them at 888-805-4555.

Interactions

Does Breyanzi interact with foods or drinks?

There are no known interactions between Breyanzi and foods or drinks.

It is unknown if drinking alcohol will affect Breyanzi, but heavy drinking can slow your immune response and make it harder for your body to fight infection and cancer.

Does Breyanzi interact with other medicines (drug interactions)?

There are no known interactions between Breyanzi and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Breyanzi?

If you or someone else has used too much Breyanzi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Breyanzi?

Breyanzi is given by a healthcare provider in a hospital. Call them right away if you are going to miss your appointment for Breyanzi or any of the other medicines you need before using Breyanzi.

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