Breyanzi Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Breyanzi Injection (lisocabtagene maraleucel) is a CAR T-cell therapy made from a patient's own white blood cells, genetically modified to recognize cancer cells and infused back as a one-time treatment. It is used to treat adults with relapsed or refractory large B-cell lymphoma after two or more prior therapies. It belongs to the antineoplastic agent / CAR T-cell therapy drug class and must be given at a specialized treatment center due to serious potential side effects.

What is Breyanzi Injection

Breyanzi is a personalized cell therapy made from a patient's own white blood cells. The cells are collected, genetically modified so they can recognize the patient's cancer cells, and then infused back into the body as a one-time treatment.

Breyanzi Injection uses

• Treatment of adults with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma) after two or more lines of systemic therapy

Benefits of Breyanzi Injection

• Treats certain large B-cell lymphomas
• Treats certain follicular lymphomas
• Treats mantle cell lymphoma
• Treats selected CLL/SLL
• Treats marginal zone lymphoma
• Uses the patient's own genetically modified T cells to target CD19-positive cancer cells

How Breyanzi Injection works

Breyanzi cells are made from the patient's own white blood cells and are changed so they can recognize lymphoma cells. When put back into the blood, they attack and kill the cancer cells.

Breyanzi Injection dosage

Breyanzi is given as a single one-time intravenous infusion, not a regular ongoing medicine. Before the infusion, patients receive a short course of chemotherapy to clear away existing white blood cells. Shortly before the infusion, patients are given acetaminophen and an antihistamine to reduce the risk of infusion reactions. The treatment is given as two separate infusions of different cell types, one right after the other. Patients should stay close to the treatment center for several weeks after infusion and return for monitoring visits in the first week. Patients should avoid driving or operating hazardous machinery for a period of time after the infusion because of possible confusion, dizziness, sleepiness, or seizures. Patients should not donate blood, organs, tissues, or cells after receiving this treatment. Certain vaccines (live vaccines) should not be given for a period before, during, and after treatment until the immune system recovers.

Available forms and strengths

• Cell suspension for intravenous infusion

Side effects of Breyanzi Injection

Common

• Fever and chills
• Tiredness
• Headache
• Nausea or vomiting
• Diarrhea or constipation
• Stomach pain
• Difficulty sleeping
• Confused thinking or feeling anxious
• Numbness and tingling in feet or hands
• Low or high blood pressure
• Cough
• Swollen ankles, arms, legs, and face
• Low red blood cells causing weakness or tiredness
• Easy bruising or bleeding

Serious

• Cytokine release syndrome (CRS) - fever, chills, difficulty breathing, dizziness, fast heartbeat, low blood pressure
• Neurologic problems - confusion, memory difficulty, trouble speaking, loss of balance, disorientation, decreased consciousness, seizures, weakness on one side of the body
• Severe infections
• Prolonged low blood cell counts (cytopenias)
• Hypogammaglobulinemia (low antibody levels)
• Severe allergic reactions including anaphylaxis
• Secondary cancers
• Hepatitis B virus reactivation
• Blood clots, stroke or mini-strokes
• Heart weakness or arrhythmias

Warnings and precautions

• Cytokine release syndrome, including fatal or life-threatening reactions, can occur after treatment. The infusion should be delayed if the patient has unresolved serious medical events, active uncontrolled infection, or active graft-versus-host disease.
• Severe or life-threatening neurologic problems can occur after treatment, sometimes along with cytokine release syndrome, after it resolves, or without it occurring at all.
• This treatment must only be given at a specialized treatment center by healthcare professionals experienced in treating blood cancers and trained to manage its serious side effects.
• Patients may develop new (secondary) cancers after treatment and should be monitored for life.
• Patients should not donate blood, organs, tissues, or cells for transplant after receiving this treatment.
• Live vaccines should not be given for at least 6 weeks before starting the chemotherapy that prepares the body for this treatment, during treatment, or until the immune system has recovered afterward.
• Serious allergic reactions, including life-threatening anaphylaxis, may occur, possibly due to an ingredient (DMSO) used to preserve the cells.
• After treatment, some commercial HIV tests may give a false-positive result because of shared genetic material between HIV and the virus used to make this medicine.
• Breyanzi is not recommended for women who are pregnant. A pregnancy test will be done before treatment, and treatment should only proceed if the result is negative. It is not known if it can harm an unborn baby.
• It is not known whether Breyanzi passes into breast milk or affects a breastfeeding child. Discuss the risks and benefits with your doctor.
• Kidney function and suitability for lymphodepleting chemotherapy require specialist assessment.
• Liver function should be evaluated as part of CAR T-cell treatment monitoring.
• It isn't known for certain if alcohol affects this treatment, but heavy drinking can weaken the immune system and make it harder for the body to fight infection and cancer.
• Do not drive, operate heavy machinery, or do other potentially dangerous activities for at least 8 weeks after receiving Breyanzi because of the risk of memory and coordination problems, sleepiness, confusion, dizziness, and seizures.

Storage

• Breyanzi is stored by health care staff in the vapor phase of liquid nitrogen (at or below minus 130°C) in a temperature-monitored system
• Once drawn into syringes, the product should be used as soon as possible and administration should not exceed 2 hours from removal from frozen storage at room temperature
• All material that has contact with Breyanzi should be handled and disposed of as potentially infectious waste according to local biosafety guidelines
• Work surfaces that may have contacted Breyanzi must be decontaminated with appropriate disinfectant

When to see a doctor

• Seek immediate medical attention for fever, chills, difficulty breathing, dizziness, nausea, headache, fast heartbeat, low blood pressure, fatigue, vomiting, diarrhea, or muscle/joint pain, which may signal cytokine release syndrome.
• Seek immediate medical attention for confusion, memory trouble, speech difficulty, trouble understanding speech, loss of balance or coordination, disorientation, reduced alertness, excessive sleepiness, loss of consciousness, delirium, seizures, shaking, or weakness on one side of the body.
• Get help right away for signs of a severe allergic reaction, such as shortness of breath or trouble breathing, skin rash, swelling of the lips, tongue, or face, chest pain, or feeling dizzy or faint.
• Talk to your doctor immediately if you think you might be pregnant after being treated.

Alternatives

• Kymriah (tisagenlecleucel)
• Tecartus (brexucabtagene autoleucel)
• Epkinly (epcoritamab)