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Lisocabtagene maraleucel (Intravenous)

Generic name: lisocabtagene maraleucel [ lis-oh-KAB-ta-jeen-mar-a-LOO-sel ]
Brand name: Breyanzi
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Sep 21, 2023.

Intravenous route(Suspension)

Warning: Cytokine Release Syndrome and Neurologic Toxicities

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving lisocabtagene maraleucel. Do not administer lisocabtagene maraleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.

Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving lisocabtagene maraleucel, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurological events after treatment with lisocabtagene maraleucel. Provide supportive care and/or corticosteroids as needed.

Lisocabtagene maraleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi(R) REMS .

Uses for lisocabtagene maraleucel

Lisocabtagene maraleucel injection is used to treat large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B that has come back (relapsed) or did not respond to the treatment (refractory) in patients who have received at least 2 previous treatments that did not work well.

Lisocabtagene maraleucel is an antineoplastic (cancer) medicine that is made from your own white blood cells, which have been modified to recognize and attack your cancer cells. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of receiving it.

This medicine is available only under a restricted distribution program called Breyanzi® REMS (Risk Evaluation and Mitigation Strategy) Program.

Before using lisocabtagene maraleucel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lisocabtagene maraleucel injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lisocabtagene maraleucel injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper use of lisocabtagene maraleucel

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins using a pump. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 15 minutes. It is given 2 to 7 days after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

You may also receive other medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before starting treatment with this medicine.

Your doctor will check you for unwanted effects at least daily for 7 days. Your doctor will also want you to stay close to the hospital or center for at least 4 weeks after your infusion.

It is very important that you understand the requirements of the Breyanzi® REMS program, and become familiar with the Breyanzi® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Detailed Lisocabtagene maraleucel dosage information

Precautions while using lisocabtagene maraleucel

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment.

This medicine may cause cytokine release syndrome (CRS), which may be life-threatening and requires immediate attention. Tell your doctor right away if you have fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These could be symptoms of a serious nerve problem.

This medicine may cause serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risks for hypogammaglobulinemia (immune system problem) and getting other cancers. Talk to your doctor if you have questions about these risks.

While you are being treated with lisocabtagene maraleucel injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 6 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

This medicine may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you, for at least 8 weeks after treatment.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Side Effects of lisocabtagene maraleucel

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Lisocabtagene maraleucel side effects (more detail)

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Therapeutic Class: Antineoplastic Agent

Chemical Class: CAR T-Cell Agent

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer