Pronunciation:

lis-oh-KAB-ta-jeen mar-a-LOO-sel

Brand Names:

• Breyanzi

Dosage Forms:

• Suspension

Warnings:

Warning: Cytokine Release Syndrome and Neurologic ToxicitiesCytokine 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.T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including lisocabtagene maraleucel.Lisocabtagene maraleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi(R) REMS .

Classifications:

Therapeutic—

Antineoplastic Agent

Chemical—

CAR T-Cell Agent

Uses of This Medicine:

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 injection is also used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have received at least 2 types of cancer treatment (eg, BTK inhibitor, BCL-2 inhibitor) that did not work well.

Lisocabtagene maraleucel injection is also used to treat follicular lymphoma (FL) that has come back (relapsed) or did not respond to the treatment (refractory) in patients who have received at least 2 prior treatments.

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 This Medicine:

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.

Children—

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.

Older adults—

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.

Other 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other interactions—

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:

• Heart problems or
• Heart rhythm problems (eg, arrhythmia, tachycardia) or
• Hypotension (low blood pressure) or
• Infections (including hepatitis B), active or history of or
• Kidney disease or
• Seizures, history of or
• Stroke, history of—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. The medicine must be injected slowly, so your IV will need to stay in place for at least 15 minutes for each cell type. 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 daily for at least 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.

Precautions While Using This Medicine:

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 require immediate treatment. Tell your doctor right away if you have a fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

This medicine may cause serious nerve problems, which may be life-threatening and require immediate medical attention, including immune effector cell-associated neurotoxicity syndrome (ICANS). Call your doctor or emergency services right away if you have a seizure, loss of balance, loss of consciousness, confusion, disorientation, difficulty speaking, or slurred speech.

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

This medicine may increase your risk of getting secondary 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 This Medicine:

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

Agitation

back pain

bleeding gums

bloody urine

blurred vision

body aches or pain

burning, numbness, tingling, or painful sensations

chest pain

chills

coma

confusion

cough

coughing up blood

decrease frequency or amount of urine

diarrhea

difficulty swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

ear congestion

fast, pounding, or irregular heartbeat or pulse

fever

hallucinations

headache

hives, itching

holding false beliefs that cannot be changed by fact

increased menstrual flow or vaginal bleeding

increased thirst

irritability

loss of appetite

loss of voice

lower back or side pain

mood or mental changes

muscle or bone pain

muscle spasm, tenderness, twitching, jerking, wasting, or weakness

nausea

nosebleeds

painful or difficult urination

paralysis

pounding in the ears

problems with speech or speaking

prolonged bleeding from cuts

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red or black, tarry stools

red or dark brown urine

runny or stuffy nose

seizures

shakiness and unsteady walk

shakiness in the legs, arms, hands, or feet

skin rash

slow or fast heartbeat

sneezing

sore throat

stiff neck

stomach pain

sweating

trembling and shaking of the hands or feet

trouble breathing

ulcers, sores, or white spots in the mouth

unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

vomiting

weight gain

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

Constipation

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site

trouble sleeping

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.